Petrelintide

updated

Petrelintide is an unapproved long-acting amylin analogue from Zealand Pharma, partnered with Roche, with a published randomized phase 2 trial in 493 adults without type 2 diabetes. Mean weight fell 7.9 to 9.8% across doses at 28 weeks versus 1.7% on placebo, and by up to 10.7% by week 42, an upper bound the abstract does not tie to a dose. Three phase 3 trials are registered and recruiting, with no results.

Long-acting amylin analogue (acylated peptide)

  • Petrelintide (ZP8396, RO7895515 in the registry) is an acylated peptide: PubChem CID 172915807, C185H305N49O61, 4192 g/mol, with no CAS number listed.
  • ZUPREME-1 randomized 493 adults (485 dosed) 5:1 to once-weekly petrelintide or placebo for 42 weeks; mean weight fell 7.9 to 9.8% at 28 weeks across doses of 1.0 to 9.0 mg versus 1.7% on placebo (efficacy estimand).
  • The 10.7% at 42 weeks is the abstract's upper bound (reductions of up to 10.7%), with no dose, estimand or placebo figure given for it.
  • The company reported on 7 October 2026 that ZUPREME-2, in 220 US participants with type 2 diabetes, gave up to 9.2% mean weight reduction at week 28 versus 2.0% on placebo. Full results are not published.
  • Three Roche-sponsored phase 3 trials (NCT07843498, NCT07843485, NCT07843472) were first posted on 28 September 2026 and are recruiting, with no results.
  • An openFDA Drugs@FDA query and a DailyMed search on 10 October 2026 found no application or label under the name petrelintide.

What is petrelintide, and is it approved?

Petrelintide is an investigational long-acting amylin analogue with no FDA approval record. Searches of FDA's Drugs@FDA and DailyMed on 10 October 2026 found no application or label under that name. The EMA was not searched.

PubChem lists petrelintide as CID 172915807, formula C185H305N49O61, molecular weight 4192 g/mol. The computed name includes an icosanoic acid chain joined through a glutamic acid unit, which marks it as an acylated peptide. The record lists no CAS number. Synonyms include ZP8396, ZP-8396 and GTPL13804.

ClinicalTrials.gov lists the intervention Petrelintide with the other name ZP8396 on the Zealand Pharma phase 2 records (NCT06662539, NCT06926842), and with the other names RO7895515 and ZP8396 on the Hoffmann-La Roche phase 3 and combination records (NCT07843498, NCT07589686). In the registry these are one intervention, and the sponsor moved from Zealand Pharma in phase 2 to Roche in phase 3. WHO Proposed INN List 129 (WHO Drug Information, Vol. 37, No. 2, 2023) lists petrelintide with the descriptor "amylin analogue" and a chemical name that includes a 19-carboxynonadecanoyl acyl group and a 3,8-anhydro (lactam) bridge, which fits the acylated peptide in the PubChem record. That list prints no development codes, so the link between the name and the codes rests on the registry and the journal papers.

On 12 March 2025, Roche announced an exclusive collaboration and licensing agreement with Zealand Pharma to co-develop and co-commercialise petrelintide, alone and as a fixed-dose combination with Roche's CT-388. The company statement described petrelintide as in phase 2 at that date, with co-commercialisation in the US and Europe and exclusive Roche commercialisation rights in the rest of the world. A 2025 medicinal chemistry paper from Zealand Pharma, with Boehringer Ingelheim co-authors, describes petrelintide as a potent, chemically stable, long-acting analogue of human amylin that can be formulated at about neutral pH. Its abstract gives no clinical efficacy data.

An openFDA Drugs@FDA query on the generic name "petrelintide" returned "No matches found" on 10 October 2026, while a control query for semaglutide returned records, and a DailyMed drug name search returned 0 labels. No FDA application or US label under that name appears in those two sources. The EMA was not searched, so status outside the United States is not covered here.

PubChem: petrelintide identity

Chemical identity record

National Library of Medicine. PubChem compound record CID 172915807 (petrelintide).

PubChem lists petrelintide with the code ZP8396 (also ZP-8396 and GTPL13804 among the synonyms), CID 172915807, formula C185H305N49O61 and molecular weight 4192 g/mol. The computed name includes an icosanoic acid chain joined through a glutamic acid unit, which marks it as an acylated peptide. The record lists no CAS number among its synonyms.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined peptide as listed in the PubChem record
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

The PubChem record lists no CAS number, so none is given on this page.

Read the original source
Registry: ZP8396, RO7895515 and petrelintide listed as one intervention

Trial registry record

ClinicalTrials.gov. NCT07843498 (Hoffmann-La Roche phase 3), with related records NCT06662539 and NCT06926842 (Zealand Pharma phase 2) and NCT07589686 (Hoffmann-La Roche combination study).

The registry lists the intervention Petrelintide with the other name ZP8396 on the Zealand Pharma phase 2 records (NCT06662539, NCT06926842), and with the other names RO7895515 and ZP8396 on the Hoffmann-La Roche phase 3 and combination records (NCT07843498, NCT07589686). In the registry, ZP8396, RO7895515 and petrelintide are therefore one intervention, and the sponsor moved from Zealand Pharma in phase 2 to Roche in phase 3. The peer-reviewed papers use petrelintide as the drug name.

Participants / model
Trial registry records, not a clinical population
Treatment
Registry intervention fields
Follow-up
Not applicable
Study design
Official trial registry
Funding
not stated in the source

The code-to-name mapping rests on the registry and the journal papers, because the WHO list prints no development codes.

Read the original source
WHO Proposed INN List 129: amylin analogue

Regulatory record

World Health Organization. Proposed International Nonproprietary Names: List 129. WHO Drug Information, Vol. 37, No. 2, 2023.

Petrelintide appears with the descriptor "amylin analogue" and a chemical name that includes a 19-carboxynonadecanoyl acyl group and a 3,8-anhydro (lactam) bridge, which fits the acylated peptide in the PubChem record. The list prints no development codes.

Participants / model
Chemical and regulatory description, not a clinical population
Treatment
Subcutaneous acylated peptide
Follow-up
Not applicable
Study design
WHO proposed INN list
Funding
not stated in the source

The list prints no development codes, so the link between the name and the codes ZP8396 and RO7895515 rests on the registry and the journal papers.

Read the original source
2025 chemistry paper: potent, stable, long-acting amylin analogue, near-neutral pH

Chemical identity record

Fischer Munch H et al. J Med Chem. 2025;68(22):23925-23940. PMID 41217931.

A 2025 medicinal chemistry paper from Zealand Pharma, with Boehringer Ingelheim co-authors, describes petrelintide as a potent, chemically stable, long-acting analogue of human amylin that can be formulated at about neutral pH, with an aim of allowing co-formulation with marketed peptide drugs. The abstract gives no clinical efficacy data.

Participants / model
Preclinical and chemistry description, not a clinical population
Treatment
Peptide design and formulation
Follow-up
Not applicable
Study design
Peer-reviewed medicinal chemistry paper (abstract only)
Funding
not stated in the source

Developer authors. The abstract gives no clinical efficacy data.

Read the original source
Roche release, 12 March 2025: petrelintide partnership with Zealand Pharma

Regulatory record

Roche. Media release dated 12 March 2025: exclusive collaboration and licensing agreement with Zealand Pharma to co-develop and co-commercialise petrelintide.

Roche announced an exclusive collaboration and licensing agreement with Zealand Pharma to co-develop and co-commercialise petrelintide, as a standalone therapy and as a fixed-dose combination with Roche's CT-388. The release described petrelintide as in phase 2 at that date, with co-commercialisation in the US and Europe and exclusive Roche commercialisation rights in the rest of the world.

Participants / model
Not a clinical population
Treatment
Not applicable
Follow-up
Statement dated 12 March 2025
Study design
Company media release
Funding
not stated in the source

A company statement dated 12 March 2025. Financial terms are not repeated here.

Read the original source
FDA record search, 10 October 2026: no application or label

Regulatory record

U.S. Food and Drug Administration, openFDA Drugs@FDA query on the generic name petrelintide, and DailyMed drug name search for petrelintide, both run on 10 October 2026.

An openFDA Drugs@FDA query on the generic name "petrelintide" returned "No matches found" (a control query for semaglutide returned records), and a DailyMed drug name search for "petrelintide" returned 0 labels. No FDA application or US label under that name appears in those two sources. The EMA was not searched.

Participants / model
FDA databases, not a clinical population
Treatment
Name search
Follow-up
Queries run on 10 October 2026
Study design
Dated US approval-record search
Funding
not stated in the source

A search result shows what the databases returned on that date. It is US-scoped and does not cover approvals elsewhere.

Read the original source

What did the phase 1 and phase 2 studies find?

In ZUPREME-1, a randomized placebo-controlled phase 2 in 493 adults without type 2 diabetes, mean weight fell 7.9 to 9.8% across doses at 28 weeks versus 1.7% on placebo, and by up to 10.7% by week 42.

ZUPREME-1 (NCT06662539) randomized 493 adults (485 dosed) 5:1 to once-weekly petrelintide at maintenance doses of 1.0 to 9.0 mg or placebo for 42 weeks including dose escalation, at 32 sites in Poland, Romania and the USA. Participants were adults without type 2 diabetes with a BMI of at least 30, or at least 27 with hypertension or dyslipidemia, with a mean baseline weight of 107.1 kg and BMI of 36.7. The primary endpoint was percent change in body weight at 28 weeks. Zealand Pharma funded the trial, and 5 of the 11 authors are Zealand employees. It was published online ahead of print on 29 September 2026.

At 28 weeks on the efficacy estimand, mean weight fell 7.9% at 1.0 mg, 7.9% at 2.5 mg, 9.8% at 5.0 mg, 9.3% at 7.0 mg and 9.4% at 9.0 mg, versus 1.7% on placebo. Estimated differences from placebo were 6.2, 6.2, 8.1, 7.7 and 7.7 percentage points. Weight kept falling to week 42, with reductions of up to 10.7% with petrelintide.

The 10.7% is the abstract's upper bound. The abstract names no dose or estimand for it and gives no placebo figure at week 42, so it is not a mean across doses and not a placebo-adjusted difference. This page draws on the abstract only, so the dose behind the 10.7%, serious adverse events, discontinuations and body composition are not described here.

Two randomized, double-blind, placebo-controlled phase 1 trials were also published, sponsored and funded by Zealand Pharma. The single ascending dose trial gave subcutaneous doses of 0.04 to 2.4 mg and one 0.35 mg intravenous dose to adults of normal weight or overweight. The multiple ascending dose trial gave six weekly 0.6 and 1.2 mg doses (part 1) and 16 weekly doses escalated to targets of 2.4, 4.8 and 9.0 mg (part 2, adults with overweight or obesity). Petrelintide was absorbed slowly with a half-life of about 10 days and dose-proportional steady state, and body weight fell by up to 8.6% after 16 weeks. The abstract does not give participant numbers.

ZUPREME-1: 493 randomized, mean weight down 7.9 to 9.8% at 28 weeks, up to 10.7% by week 42

Randomized controlled trial

Garvey WT et al. Lancet Diabetes Endocrinol. 2026. PMID 42810355.

ZUPREME-1 (NCT06662539) randomized 493 adults (485 dosed) 5:1 to once-weekly petrelintide maintenance doses of 1.0 to 9.0 mg or placebo for 42 weeks including dose escalation, at 32 sites in Poland, Romania and the USA. On the efficacy estimand, mean weight fell 7.9% (1.0 mg), 7.9% (2.5 mg), 9.8% (5.0 mg), 9.3% (7.0 mg) and 9.4% (9.0 mg) at 28 weeks, versus 1.7% with placebo, with estimated differences from placebo of 6.2, 6.2, 8.1, 7.7 and 7.7 percentage points. Weight kept falling to week 42, with reductions of up to 10.7% with petrelintide. Nausea occurred in 79 (20%) of 404 petrelintide participants versus 5 (6%) of 81 on placebo, vomiting in 12 (3%) versus 5 (6%), diarrhea in 30 (7%) versus 6 (7%) and constipation in 28 (7%) versus 3 (4%). No deaths were reported.

Participants / model
493 randomized adults (485 dosed) without type 2 diabetes with a BMI of at least 30, or at least 27 with hypertension or dyslipidemia; mean baseline weight 107.1 kg, BMI 36.7
Treatment
Subcutaneous petrelintide once weekly, maintenance doses of 1.0 to 9.0 mg, or placebo
Follow-up
42 weeks including dose escalation; primary endpoint at 28 weeks
Study design
Randomized, placebo-controlled phase 2 trial, 5:1, 32 sites in Poland, Romania and the USA
Funding
Funded by Zealand Pharma; 5 of the 11 authors are Zealand employees

Published online ahead of print on 29 September 2026. Only the abstract was available. The 10.7% is the abstract's upper bound: it names no dose or estimand and gives no placebo figure at week 42, so it is not a mean across doses and not a placebo-adjusted difference. Serious adverse event counts, discontinuation rates, heart rate, blood pressure and body composition are not in the abstract.

Read the original source
Phase 1: two randomized trials, half-life about 10 days, weight down by up to 8.6% at 16 weeks

Randomized controlled trial

Brændholt Olsen M et al. Diabetes Obes Metab. 2026;28(7):5915-5925. PMID 42017294.

Two randomized, double-blind, placebo-controlled phase 1 trials gave subcutaneous petrelintide at 0.04 to 2.4 mg and one 0.35 mg intravenous dose (single ascending dose), six weekly 0.6 and 1.2 mg doses (multiple ascending dose part 1), and 16 weekly doses escalated to targets of 2.4, 4.8 and 9.0 mg (part 2). There were no serious or severe treatment-emergent adverse events. The most common events were gastrointestinal and mostly mild, and one participant stopped for them. In part 2, nausea occurred in 16.7 to 33.3% of petrelintide participants versus 16.7% of placebo participants. Petrelintide was absorbed slowly with a half-life of about 10 days and dose-proportional steady state, and body weight fell by up to 8.6% after 16 weeks.

Participants / model
Adults of normal weight or overweight (single dose and multiple dose part 1) and adults with overweight or obesity (part 2); participant numbers not given in the abstract
Treatment
Subcutaneous petrelintide once weekly, and a single intravenous dose
Follow-up
Single dose; six weekly doses (part 1); 16 weekly doses (part 2)
Study design
Two randomized, double-blind, placebo-controlled phase 1 trials
Funding
Zealand Pharma sponsored and funded the work

The abstract does not give participant numbers. The 8.6% is an upper bound ("up to"), not a mean.

Read the original source

What did the type 2 diabetes phase 2 report?

The company reported on 7 October 2026 that in 220 US participants with type 2 diabetes, mean weight fell by up to 9.2% at week 28 versus 2.0% on placebo. These are topline figures from a company announcement, with no published full results and none posted in the registry.

On 7 October 2026, Zealand Pharma reported topline results from ZUPREME-2 (NCT06926842) in company announcement No. 54 / 2026. The study enrolled 220 US participants with overweight or obesity and type 2 diabetes on metformin with or without an SGLT2 inhibitor. The registry lists 221 enrolled, while the announcement says 220. The announcement does not state the doses of the three petrelintide arms.

At week 28 on the efficacy estimand, the company reported up to 9.2% mean weight reduction (a range of 7.4 to 9.2% across the three petrelintide arms) versus 2.0% with placebo. It described the treatment-regimen estimand as largely consistent and gave no figures for it. HbA1c fell by up to 0.65% versus a 0.23% rise on placebo, and the placebo-adjusted fall was 0.61 to 0.88 percentage points. The company reported discontinuation for gastrointestinal adverse events of 1.9% versus 1.7%, and no unexpected safety signals.

These figures come from a company announcement and are not peer reviewed. The "up to" figures describe the best arm, not a mean across arms.

Company statement, 7 October 2026: ZUPREME-2 in type 2 diabetes, up to 9.2% at 28 weeks

Clinical trial

Zealand Pharma. Company announcement No. 54 / 2026, dated 7 October 2026: topline results from ZUPREME-2 (NCT06926842).

The company reported results from 220 US participants with overweight or obesity and type 2 diabetes on metformin with or without an SGLT2 inhibitor. At week 28, it reported up to 9.2% mean weight reduction (range 7.4 to 9.2% across the three petrelintide arms) versus 2.0% with placebo on the efficacy estimand, and described the treatment-regimen estimand as largely consistent without giving figures. HbA1c fell by up to 0.65% versus a 0.23% rise on placebo, and the placebo-adjusted fall was 0.61 to 0.88 percentage points. Discontinuation for gastrointestinal adverse events was 1.9% versus 1.7%. The company reported no unexpected safety signals.

Participants / model
Adults with overweight or obesity and type 2 diabetes on metformin with or without an SGLT2 inhibitor (220 US participants per the announcement; the registry lists 221 enrolled)
Treatment
Subcutaneous petrelintide once weekly, three dose arms (doses not stated in the announcement), or placebo
Follow-up
28 weeks
Study design
Company topline announcement of a randomized phase 2 trial; not peer reviewed
Funding
not stated in the source

A company statement dated 7 October 2026. Full results had not been presented or published, and the registry has no posted results. Figures given as "up to" are the best arm, not a mean across arms.

Read the original source

Has phase 3 started, and what else is registered?

Three Roche-sponsored phase 3 trials were first posted on 28 September 2026 with start dates of 30 September 2026. All three are recruiting with no results. A registration is not an outcome.

The three trials are randomized, quadruple-masked and placebo-controlled, use a drug-device combination product, and have a primary outcome of percent change in body weight from baseline to week 64. The planned populations are adults with overweight or obesity: NCT07843498 (with a weight-related comorbidity and no type 2 diabetes, estimated 3900, primary completion 21 December 2028), NCT07843485 (with type 2 diabetes, estimated 600, 20 October 2028) and NCT07843472 (with established cardiovascular disease, estimated 2500, 28 July 2030). A company announcement dated 7 October 2026 says first participants have started treatment. These are registrations and a company statement, and no phase 3 result exists.

A combination study is also registered. NCT07589686 (Roche) is a randomized, double-blind phase 2 of petrelintide with enicepatide (also coded RO7795068, CT-388 and RG6640) against each alone and placebo, estimated 486 adults, with a primary outcome of percent change in body weight to week 40. It was listed as not yet recruiting at the 9 September 2026 update, with no results.

Clinical pharmacology studies are registered with no posted results: renal impairment (NCT07076030, 39 participants, completed), drug product concentrations (NCT07338214, 48, completed) and hepatic impairment (NCT07682818, 36, recruiting). No public organ-impairment dosing data were found in the records reviewed.

Registry: three Roche phase 3 trials, recruiting, no results

Trial registry record

ClinicalTrials.gov. NCT07843485, with related records NCT07843498 and NCT07843472 (Hoffmann-La Roche).

Three Roche-sponsored, randomized, quadruple-masked, placebo-controlled phase 3 trials were first posted on 28 September 2026 with start dates of 30 September 2026, a drug-device combination product and a primary outcome of percent change in body weight from baseline to week 64: NCT07843498 (obesity or overweight with a weight-related comorbidity, no type 2 diabetes, estimated 3900, primary completion 21 December 2028), NCT07843485 (with type 2 diabetes, estimated 600, 20 October 2028) and NCT07843472 (with established cardiovascular disease, estimated 2500, 28 July 2030). All three are recruiting with no results. A company announcement dated 7 October 2026 says first participants have started treatment. A registration is not an outcome.

Participants / model
Adults with overweight or obesity (planned populations)
Treatment
Subcutaneous petrelintide once weekly, drug-device combination product
Follow-up
Primary outcome at week 64 (planned)
Study design
Official trial registry
Funding
not stated in the source

Registrations and estimated dates, not outcomes. No phase 3 results exist.

Read the original source
Registry: petrelintide plus enicepatide, 486 planned, not yet recruiting

Trial registry record

ClinicalTrials.gov. NCT07589686 (Hoffmann-La Roche).

NCT07589686 (Roche) is a randomized, double-blind phase 2 of petrelintide with enicepatide (also coded RO7795068, CT-388 and RG6640) against each alone and placebo, estimated 486 adults, primary outcome percent change in body weight to week 40. It was listed as not yet recruiting at the 9 September 2026 update, with no results.

Participants / model
Adults with obesity or overweight (planned)
Treatment
Subcutaneous once weekly, two peptides
Follow-up
Primary outcome at week 40 (planned)
Study design
Official trial registry
Funding
not stated in the source

A registration, not an outcome.

Read the original source
Registry: renal, hepatic and drug product studies, no posted results

Trial registry record

ClinicalTrials.gov. NCT07076030, with related records NCT07338214 and NCT07682818.

Clinical pharmacology studies are registered with no posted results: renal impairment (NCT07076030, 39 participants, completed), drug product concentrations (NCT07338214, 48, completed) and hepatic impairment (NCT07682818, 36, recruiting). No public organ-impairment dosing data were found in the records reviewed.

Participants / model
Not a clinical population
Treatment
Subcutaneous
Follow-up
Not applicable
Study design
Official trial registry
Funding
not stated in the source

Registrations, not outcomes.

Read the original source

Is the claim of 10.7% weight loss at 42 weeks with phase 3 due in late 2026 accurate?

Partly. The 10.7% at 42 weeks is the abstract's upper bound (up to 10.7%), not a mean for a named dose. Phase 3 is not only planned: three Roche trials were first posted on 28 September 2026 with start dates of 30 September 2026.

The claim describes petrelintide as a long-acting amylin analog from Zealand Pharma, partnered with Roche, said to give 10.7% weight loss at 42 weeks with phase 3 starting in the second half of 2026.

The developer, the Roche partnership and the amylin analogue description are confirmed in the sources above. The 10.7% is real but narrower than it sounds: the published abstract says weight fell by up to 10.7% with petrelintide by week 42, and names no dose or estimand for it. It is not a mean across doses and not a placebo-adjusted difference, and the abstract gives no placebo figure at week 42. At 28 weeks, mean reductions by dose were 7.9 to 9.8% versus 1.7% on placebo.

Phase 3 is registered and under way rather than planned. Three Roche trials were first posted on 28 September 2026 with start dates of 30 September 2026, and a company announcement dated 7 October 2026 says first participants have started treatment. They have no results.

ZUPREME-1: 493 randomized, mean weight down 7.9 to 9.8% at 28 weeks, up to 10.7% by week 42

Randomized controlled trial

Garvey WT et al. Lancet Diabetes Endocrinol. 2026. PMID 42810355.

ZUPREME-1 (NCT06662539) randomized 493 adults (485 dosed) 5:1 to once-weekly petrelintide maintenance doses of 1.0 to 9.0 mg or placebo for 42 weeks including dose escalation, at 32 sites in Poland, Romania and the USA. On the efficacy estimand, mean weight fell 7.9% (1.0 mg), 7.9% (2.5 mg), 9.8% (5.0 mg), 9.3% (7.0 mg) and 9.4% (9.0 mg) at 28 weeks, versus 1.7% with placebo, with estimated differences from placebo of 6.2, 6.2, 8.1, 7.7 and 7.7 percentage points. Weight kept falling to week 42, with reductions of up to 10.7% with petrelintide. Nausea occurred in 79 (20%) of 404 petrelintide participants versus 5 (6%) of 81 on placebo, vomiting in 12 (3%) versus 5 (6%), diarrhea in 30 (7%) versus 6 (7%) and constipation in 28 (7%) versus 3 (4%). No deaths were reported.

Participants / model
493 randomized adults (485 dosed) without type 2 diabetes with a BMI of at least 30, or at least 27 with hypertension or dyslipidemia; mean baseline weight 107.1 kg, BMI 36.7
Treatment
Subcutaneous petrelintide once weekly, maintenance doses of 1.0 to 9.0 mg, or placebo
Follow-up
42 weeks including dose escalation; primary endpoint at 28 weeks
Study design
Randomized, placebo-controlled phase 2 trial, 5:1, 32 sites in Poland, Romania and the USA
Funding
Funded by Zealand Pharma; 5 of the 11 authors are Zealand employees

Published online ahead of print on 29 September 2026. Only the abstract was available. The 10.7% is the abstract's upper bound: it names no dose or estimand and gives no placebo figure at week 42, so it is not a mean across doses and not a placebo-adjusted difference. Serious adverse event counts, discontinuation rates, heart rate, blood pressure and body composition are not in the abstract.

Read the original source
Registry: three Roche phase 3 trials, recruiting, no results

Trial registry record

ClinicalTrials.gov. NCT07843485, with related records NCT07843498 and NCT07843472 (Hoffmann-La Roche).

Three Roche-sponsored, randomized, quadruple-masked, placebo-controlled phase 3 trials were first posted on 28 September 2026 with start dates of 30 September 2026, a drug-device combination product and a primary outcome of percent change in body weight from baseline to week 64: NCT07843498 (obesity or overweight with a weight-related comorbidity, no type 2 diabetes, estimated 3900, primary completion 21 December 2028), NCT07843485 (with type 2 diabetes, estimated 600, 20 October 2028) and NCT07843472 (with established cardiovascular disease, estimated 2500, 28 July 2030). All three are recruiting with no results. A company announcement dated 7 October 2026 says first participants have started treatment. A registration is not an outcome.

Participants / model
Adults with overweight or obesity (planned populations)
Treatment
Subcutaneous petrelintide once weekly, drug-device combination product
Follow-up
Primary outcome at week 64 (planned)
Study design
Official trial registry
Funding
not stated in the source

Registrations and estimated dates, not outcomes. No phase 3 results exist.

Read the original source
Roche release, 12 March 2025: petrelintide partnership with Zealand Pharma

Regulatory record

Roche. Media release dated 12 March 2025: exclusive collaboration and licensing agreement with Zealand Pharma to co-develop and co-commercialise petrelintide.

Roche announced an exclusive collaboration and licensing agreement with Zealand Pharma to co-develop and co-commercialise petrelintide, as a standalone therapy and as a fixed-dose combination with Roche's CT-388. The release described petrelintide as in phase 2 at that date, with co-commercialisation in the US and Europe and exclusive Roche commercialisation rights in the rest of the world.

Participants / model
Not a clinical population
Treatment
Not applicable
Follow-up
Statement dated 12 March 2025
Study design
Company media release
Funding
not stated in the source

A company statement dated 12 March 2025. Financial terms are not repeated here.

Read the original source

How does petrelintide work, and how long does it last in the body?

Petrelintide is a long-acting analogue of human amylin, built as an acylated peptide. In the published phase 1 trials it was absorbed slowly with a half-life of about 10 days.

A 2025 medicinal chemistry paper from Zealand Pharma describes petrelintide as a potent, chemically stable, long-acting analogue of human amylin that can be formulated at about neutral pH, with an aim of allowing co-formulation with marketed peptide drugs. PubChem lists an icosanoic acid chain joined through a glutamic acid unit, and WHO lists the name with the descriptor "amylin analogue". The chemistry paper's abstract gives no clinical data.

In the two phase 1 trials, petrelintide was absorbed slowly with a half-life of about 10 days and dose-proportional steady state after subcutaneous dosing. The abstract does not give participant numbers or other pharmacokinetic values. Studies in renal and hepatic impairment are registered with no posted results.

2025 chemistry paper: potent, stable, long-acting amylin analogue, near-neutral pH

Chemical identity record

Fischer Munch H et al. J Med Chem. 2025;68(22):23925-23940. PMID 41217931.

A 2025 medicinal chemistry paper from Zealand Pharma, with Boehringer Ingelheim co-authors, describes petrelintide as a potent, chemically stable, long-acting analogue of human amylin that can be formulated at about neutral pH, with an aim of allowing co-formulation with marketed peptide drugs. The abstract gives no clinical efficacy data.

Participants / model
Preclinical and chemistry description, not a clinical population
Treatment
Peptide design and formulation
Follow-up
Not applicable
Study design
Peer-reviewed medicinal chemistry paper (abstract only)
Funding
not stated in the source

Developer authors. The abstract gives no clinical efficacy data.

Read the original source
PubChem: petrelintide identity

Chemical identity record

National Library of Medicine. PubChem compound record CID 172915807 (petrelintide).

PubChem lists petrelintide with the code ZP8396 (also ZP-8396 and GTPL13804 among the synonyms), CID 172915807, formula C185H305N49O61 and molecular weight 4192 g/mol. The computed name includes an icosanoic acid chain joined through a glutamic acid unit, which marks it as an acylated peptide. The record lists no CAS number among its synonyms.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined peptide as listed in the PubChem record
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

The PubChem record lists no CAS number, so none is given on this page.

Read the original source
WHO Proposed INN List 129: amylin analogue

Regulatory record

World Health Organization. Proposed International Nonproprietary Names: List 129. WHO Drug Information, Vol. 37, No. 2, 2023.

Petrelintide appears with the descriptor "amylin analogue" and a chemical name that includes a 19-carboxynonadecanoyl acyl group and a 3,8-anhydro (lactam) bridge, which fits the acylated peptide in the PubChem record. The list prints no development codes.

Participants / model
Chemical and regulatory description, not a clinical population
Treatment
Subcutaneous acylated peptide
Follow-up
Not applicable
Study design
WHO proposed INN list
Funding
not stated in the source

The list prints no development codes, so the link between the name and the codes ZP8396 and RO7895515 rests on the registry and the journal papers.

Read the original source
Phase 1: two randomized trials, half-life about 10 days, weight down by up to 8.6% at 16 weeks

Randomized controlled trial

Brændholt Olsen M et al. Diabetes Obes Metab. 2026;28(7):5915-5925. PMID 42017294.

Two randomized, double-blind, placebo-controlled phase 1 trials gave subcutaneous petrelintide at 0.04 to 2.4 mg and one 0.35 mg intravenous dose (single ascending dose), six weekly 0.6 and 1.2 mg doses (multiple ascending dose part 1), and 16 weekly doses escalated to targets of 2.4, 4.8 and 9.0 mg (part 2). There were no serious or severe treatment-emergent adverse events. The most common events were gastrointestinal and mostly mild, and one participant stopped for them. In part 2, nausea occurred in 16.7 to 33.3% of petrelintide participants versus 16.7% of placebo participants. Petrelintide was absorbed slowly with a half-life of about 10 days and dose-proportional steady state, and body weight fell by up to 8.6% after 16 weeks.

Participants / model
Adults of normal weight or overweight (single dose and multiple dose part 1) and adults with overweight or obesity (part 2); participant numbers not given in the abstract
Treatment
Subcutaneous petrelintide once weekly, and a single intravenous dose
Follow-up
Single dose; six weekly doses (part 1); 16 weekly doses (part 2)
Study design
Two randomized, double-blind, placebo-controlled phase 1 trials
Funding
Zealand Pharma sponsored and funded the work

The abstract does not give participant numbers. The 8.6% is an upper bound ("up to"), not a mean.

Read the original source
Registry: renal, hepatic and drug product studies, no posted results

Trial registry record

ClinicalTrials.gov. NCT07076030, with related records NCT07338214 and NCT07682818.

Clinical pharmacology studies are registered with no posted results: renal impairment (NCT07076030, 39 participants, completed), drug product concentrations (NCT07338214, 48, completed) and hepatic impairment (NCT07682818, 36, recruiting). No public organ-impairment dosing data were found in the records reviewed.

Participants / model
Not a clinical population
Treatment
Subcutaneous
Follow-up
Not applicable
Study design
Official trial registry
Funding
not stated in the source

Registrations, not outcomes.

Read the original source

What risks did the studies report?

In ZUPREME-1, nausea occurred in 79 of 404 (20%) on petrelintide versus 5 of 81 (6%) on placebo, with no deaths reported. In the phase 1 trials there were no serious or severe treatment-emergent adverse events. No phase 3 result and no long-term safety data exist.

In ZUPREME-1, nausea occurred in 79 (20%) of 404 petrelintide participants versus 5 (6%) of 81 on placebo, vomiting in 12 (3%) versus 5 (6%), diarrhea in 30 (7%) versus 6 (7%) and constipation in 28 (7%) versus 3 (4%). No deaths were reported. The abstract calls gastrointestinal tolerability similar to placebo apart from mostly mild nausea during dose escalation. Serious adverse event counts, discontinuation rates, heart rate, blood pressure and body composition are not in the abstract.

In the two phase 1 trials there were no serious or severe treatment-emergent adverse events. The most common events were gastrointestinal and mostly mild, and one participant stopped for them. In part 2 of the multiple ascending dose trial, nausea occurred in 16.7 to 33.3% of petrelintide participants versus 16.7% of placebo participants.

In ZUPREME-2 the company reported discontinuation for gastrointestinal adverse events of 1.9% versus 1.7% on placebo and no unexpected safety signals. That is a company statement dated 7 October 2026, without full results.

There is no phase 3 result, no independent replication and no long-term safety data. Studies in renal and hepatic impairment are registered with no posted results.

ZUPREME-1: 493 randomized, mean weight down 7.9 to 9.8% at 28 weeks, up to 10.7% by week 42

Randomized controlled trial

Garvey WT et al. Lancet Diabetes Endocrinol. 2026. PMID 42810355.

ZUPREME-1 (NCT06662539) randomized 493 adults (485 dosed) 5:1 to once-weekly petrelintide maintenance doses of 1.0 to 9.0 mg or placebo for 42 weeks including dose escalation, at 32 sites in Poland, Romania and the USA. On the efficacy estimand, mean weight fell 7.9% (1.0 mg), 7.9% (2.5 mg), 9.8% (5.0 mg), 9.3% (7.0 mg) and 9.4% (9.0 mg) at 28 weeks, versus 1.7% with placebo, with estimated differences from placebo of 6.2, 6.2, 8.1, 7.7 and 7.7 percentage points. Weight kept falling to week 42, with reductions of up to 10.7% with petrelintide. Nausea occurred in 79 (20%) of 404 petrelintide participants versus 5 (6%) of 81 on placebo, vomiting in 12 (3%) versus 5 (6%), diarrhea in 30 (7%) versus 6 (7%) and constipation in 28 (7%) versus 3 (4%). No deaths were reported.

Participants / model
493 randomized adults (485 dosed) without type 2 diabetes with a BMI of at least 30, or at least 27 with hypertension or dyslipidemia; mean baseline weight 107.1 kg, BMI 36.7
Treatment
Subcutaneous petrelintide once weekly, maintenance doses of 1.0 to 9.0 mg, or placebo
Follow-up
42 weeks including dose escalation; primary endpoint at 28 weeks
Study design
Randomized, placebo-controlled phase 2 trial, 5:1, 32 sites in Poland, Romania and the USA
Funding
Funded by Zealand Pharma; 5 of the 11 authors are Zealand employees

Published online ahead of print on 29 September 2026. Only the abstract was available. The 10.7% is the abstract's upper bound: it names no dose or estimand and gives no placebo figure at week 42, so it is not a mean across doses and not a placebo-adjusted difference. Serious adverse event counts, discontinuation rates, heart rate, blood pressure and body composition are not in the abstract.

Read the original source
Phase 1: two randomized trials, half-life about 10 days, weight down by up to 8.6% at 16 weeks

Randomized controlled trial

Brændholt Olsen M et al. Diabetes Obes Metab. 2026;28(7):5915-5925. PMID 42017294.

Two randomized, double-blind, placebo-controlled phase 1 trials gave subcutaneous petrelintide at 0.04 to 2.4 mg and one 0.35 mg intravenous dose (single ascending dose), six weekly 0.6 and 1.2 mg doses (multiple ascending dose part 1), and 16 weekly doses escalated to targets of 2.4, 4.8 and 9.0 mg (part 2). There were no serious or severe treatment-emergent adverse events. The most common events were gastrointestinal and mostly mild, and one participant stopped for them. In part 2, nausea occurred in 16.7 to 33.3% of petrelintide participants versus 16.7% of placebo participants. Petrelintide was absorbed slowly with a half-life of about 10 days and dose-proportional steady state, and body weight fell by up to 8.6% after 16 weeks.

Participants / model
Adults of normal weight or overweight (single dose and multiple dose part 1) and adults with overweight or obesity (part 2); participant numbers not given in the abstract
Treatment
Subcutaneous petrelintide once weekly, and a single intravenous dose
Follow-up
Single dose; six weekly doses (part 1); 16 weekly doses (part 2)
Study design
Two randomized, double-blind, placebo-controlled phase 1 trials
Funding
Zealand Pharma sponsored and funded the work

The abstract does not give participant numbers. The 8.6% is an upper bound ("up to"), not a mean.

Read the original source
Company statement, 7 October 2026: ZUPREME-2 in type 2 diabetes, up to 9.2% at 28 weeks

Clinical trial

Zealand Pharma. Company announcement No. 54 / 2026, dated 7 October 2026: topline results from ZUPREME-2 (NCT06926842).

The company reported results from 220 US participants with overweight or obesity and type 2 diabetes on metformin with or without an SGLT2 inhibitor. At week 28, it reported up to 9.2% mean weight reduction (range 7.4 to 9.2% across the three petrelintide arms) versus 2.0% with placebo on the efficacy estimand, and described the treatment-regimen estimand as largely consistent without giving figures. HbA1c fell by up to 0.65% versus a 0.23% rise on placebo, and the placebo-adjusted fall was 0.61 to 0.88 percentage points. Discontinuation for gastrointestinal adverse events was 1.9% versus 1.7%. The company reported no unexpected safety signals.

Participants / model
Adults with overweight or obesity and type 2 diabetes on metformin with or without an SGLT2 inhibitor (220 US participants per the announcement; the registry lists 221 enrolled)
Treatment
Subcutaneous petrelintide once weekly, three dose arms (doses not stated in the announcement), or placebo
Follow-up
28 weeks
Study design
Company topline announcement of a randomized phase 2 trial; not peer reviewed
Funding
not stated in the source

A company statement dated 7 October 2026. Full results had not been presented or published, and the registry has no posted results. Figures given as "up to" are the best arm, not a mean across arms.

Read the original source
Registry: renal, hepatic and drug product studies, no posted results

Trial registry record

ClinicalTrials.gov. NCT07076030, with related records NCT07338214 and NCT07682818.

Clinical pharmacology studies are registered with no posted results: renal impairment (NCT07076030, 39 participants, completed), drug product concentrations (NCT07338214, 48, completed) and hepatic impairment (NCT07682818, 36, recruiting). No public organ-impairment dosing data were found in the records reviewed.

Participants / model
Not a clinical population
Treatment
Subcutaneous
Follow-up
Not applicable
Study design
Official trial registry
Funding
not stated in the source

Registrations, not outcomes.

Read the original source

Why does petrelintide sit in B tier?

A published randomized phase 2 in 493 adults shows 7.9 to 9.8% mean weight loss at 28 weeks, and phase 3 is registered. B stops short of a higher grade because there is no phase 3 result, no approval record, no independent replication and no long-term safety data.

The B rests on a published randomized, placebo-controlled phase 2 trial (493 randomized, 7.9 to 9.8% mean weight loss at 28 weeks and up to 10.7% by week 42) and published phase 1 data, with a second phase 2 in type 2 diabetes reported only by the company. The amylin analogue description and the early outcomes are consistent across the sources.

It stops there because phase 3 has no results, no FDA application or US label exists under the name, no independent replication is published, and no long-term safety data exist. This is the same tier as cagrilintide and eloralintide.

ZUPREME-1: 493 randomized, mean weight down 7.9 to 9.8% at 28 weeks, up to 10.7% by week 42

Randomized controlled trial

Garvey WT et al. Lancet Diabetes Endocrinol. 2026. PMID 42810355.

ZUPREME-1 (NCT06662539) randomized 493 adults (485 dosed) 5:1 to once-weekly petrelintide maintenance doses of 1.0 to 9.0 mg or placebo for 42 weeks including dose escalation, at 32 sites in Poland, Romania and the USA. On the efficacy estimand, mean weight fell 7.9% (1.0 mg), 7.9% (2.5 mg), 9.8% (5.0 mg), 9.3% (7.0 mg) and 9.4% (9.0 mg) at 28 weeks, versus 1.7% with placebo, with estimated differences from placebo of 6.2, 6.2, 8.1, 7.7 and 7.7 percentage points. Weight kept falling to week 42, with reductions of up to 10.7% with petrelintide. Nausea occurred in 79 (20%) of 404 petrelintide participants versus 5 (6%) of 81 on placebo, vomiting in 12 (3%) versus 5 (6%), diarrhea in 30 (7%) versus 6 (7%) and constipation in 28 (7%) versus 3 (4%). No deaths were reported.

Participants / model
493 randomized adults (485 dosed) without type 2 diabetes with a BMI of at least 30, or at least 27 with hypertension or dyslipidemia; mean baseline weight 107.1 kg, BMI 36.7
Treatment
Subcutaneous petrelintide once weekly, maintenance doses of 1.0 to 9.0 mg, or placebo
Follow-up
42 weeks including dose escalation; primary endpoint at 28 weeks
Study design
Randomized, placebo-controlled phase 2 trial, 5:1, 32 sites in Poland, Romania and the USA
Funding
Funded by Zealand Pharma; 5 of the 11 authors are Zealand employees

Published online ahead of print on 29 September 2026. Only the abstract was available. The 10.7% is the abstract's upper bound: it names no dose or estimand and gives no placebo figure at week 42, so it is not a mean across doses and not a placebo-adjusted difference. Serious adverse event counts, discontinuation rates, heart rate, blood pressure and body composition are not in the abstract.

Read the original source
Phase 1: two randomized trials, half-life about 10 days, weight down by up to 8.6% at 16 weeks

Randomized controlled trial

Brændholt Olsen M et al. Diabetes Obes Metab. 2026;28(7):5915-5925. PMID 42017294.

Two randomized, double-blind, placebo-controlled phase 1 trials gave subcutaneous petrelintide at 0.04 to 2.4 mg and one 0.35 mg intravenous dose (single ascending dose), six weekly 0.6 and 1.2 mg doses (multiple ascending dose part 1), and 16 weekly doses escalated to targets of 2.4, 4.8 and 9.0 mg (part 2). There were no serious or severe treatment-emergent adverse events. The most common events were gastrointestinal and mostly mild, and one participant stopped for them. In part 2, nausea occurred in 16.7 to 33.3% of petrelintide participants versus 16.7% of placebo participants. Petrelintide was absorbed slowly with a half-life of about 10 days and dose-proportional steady state, and body weight fell by up to 8.6% after 16 weeks.

Participants / model
Adults of normal weight or overweight (single dose and multiple dose part 1) and adults with overweight or obesity (part 2); participant numbers not given in the abstract
Treatment
Subcutaneous petrelintide once weekly, and a single intravenous dose
Follow-up
Single dose; six weekly doses (part 1); 16 weekly doses (part 2)
Study design
Two randomized, double-blind, placebo-controlled phase 1 trials
Funding
Zealand Pharma sponsored and funded the work

The abstract does not give participant numbers. The 8.6% is an upper bound ("up to"), not a mean.

Read the original source
Company statement, 7 October 2026: ZUPREME-2 in type 2 diabetes, up to 9.2% at 28 weeks

Clinical trial

Zealand Pharma. Company announcement No. 54 / 2026, dated 7 October 2026: topline results from ZUPREME-2 (NCT06926842).

The company reported results from 220 US participants with overweight or obesity and type 2 diabetes on metformin with or without an SGLT2 inhibitor. At week 28, it reported up to 9.2% mean weight reduction (range 7.4 to 9.2% across the three petrelintide arms) versus 2.0% with placebo on the efficacy estimand, and described the treatment-regimen estimand as largely consistent without giving figures. HbA1c fell by up to 0.65% versus a 0.23% rise on placebo, and the placebo-adjusted fall was 0.61 to 0.88 percentage points. Discontinuation for gastrointestinal adverse events was 1.9% versus 1.7%. The company reported no unexpected safety signals.

Participants / model
Adults with overweight or obesity and type 2 diabetes on metformin with or without an SGLT2 inhibitor (220 US participants per the announcement; the registry lists 221 enrolled)
Treatment
Subcutaneous petrelintide once weekly, three dose arms (doses not stated in the announcement), or placebo
Follow-up
28 weeks
Study design
Company topline announcement of a randomized phase 2 trial; not peer reviewed
Funding
not stated in the source

A company statement dated 7 October 2026. Full results had not been presented or published, and the registry has no posted results. Figures given as "up to" are the best arm, not a mean across arms.

Read the original source
Registry: three Roche phase 3 trials, recruiting, no results

Trial registry record

ClinicalTrials.gov. NCT07843485, with related records NCT07843498 and NCT07843472 (Hoffmann-La Roche).

Three Roche-sponsored, randomized, quadruple-masked, placebo-controlled phase 3 trials were first posted on 28 September 2026 with start dates of 30 September 2026, a drug-device combination product and a primary outcome of percent change in body weight from baseline to week 64: NCT07843498 (obesity or overweight with a weight-related comorbidity, no type 2 diabetes, estimated 3900, primary completion 21 December 2028), NCT07843485 (with type 2 diabetes, estimated 600, 20 October 2028) and NCT07843472 (with established cardiovascular disease, estimated 2500, 28 July 2030). All three are recruiting with no results. A company announcement dated 7 October 2026 says first participants have started treatment. A registration is not an outcome.

Participants / model
Adults with overweight or obesity (planned populations)
Treatment
Subcutaneous petrelintide once weekly, drug-device combination product
Follow-up
Primary outcome at week 64 (planned)
Study design
Official trial registry
Funding
not stated in the source

Registrations and estimated dates, not outcomes. No phase 3 results exist.

Read the original source
FDA record search, 10 October 2026: no application or label

Regulatory record

U.S. Food and Drug Administration, openFDA Drugs@FDA query on the generic name petrelintide, and DailyMed drug name search for petrelintide, both run on 10 October 2026.

An openFDA Drugs@FDA query on the generic name "petrelintide" returned "No matches found" (a control query for semaglutide returned records), and a DailyMed drug name search for "petrelintide" returned 0 labels. No FDA application or US label under that name appears in those two sources. The EMA was not searched.

Participants / model
FDA databases, not a clinical population
Treatment
Name search
Follow-up
Queries run on 10 October 2026
Study design
Dated US approval-record search
Funding
not stated in the source

A search result shows what the databases returned on that date. It is US-scoped and does not cover approvals elsewhere.

Read the original source

Studies and sources

PubChem: petrelintide identity

Chemical identity record

National Library of Medicine. PubChem compound record CID 172915807 (petrelintide).

PubChem lists petrelintide with the code ZP8396 (also ZP-8396 and GTPL13804 among the synonyms), CID 172915807, formula C185H305N49O61 and molecular weight 4192 g/mol. The computed name includes an icosanoic acid chain joined through a glutamic acid unit, which marks it as an acylated peptide. The record lists no CAS number among its synonyms.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined peptide as listed in the PubChem record
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

The PubChem record lists no CAS number, so none is given on this page.

Read the original source
Registry: ZP8396, RO7895515 and petrelintide listed as one intervention

Trial registry record

ClinicalTrials.gov. NCT07843498 (Hoffmann-La Roche phase 3), with related records NCT06662539 and NCT06926842 (Zealand Pharma phase 2) and NCT07589686 (Hoffmann-La Roche combination study).

The registry lists the intervention Petrelintide with the other name ZP8396 on the Zealand Pharma phase 2 records (NCT06662539, NCT06926842), and with the other names RO7895515 and ZP8396 on the Hoffmann-La Roche phase 3 and combination records (NCT07843498, NCT07589686). In the registry, ZP8396, RO7895515 and petrelintide are therefore one intervention, and the sponsor moved from Zealand Pharma in phase 2 to Roche in phase 3. The peer-reviewed papers use petrelintide as the drug name.

Participants / model
Trial registry records, not a clinical population
Treatment
Registry intervention fields
Follow-up
Not applicable
Study design
Official trial registry
Funding
not stated in the source

The code-to-name mapping rests on the registry and the journal papers, because the WHO list prints no development codes.

Read the original source
WHO Proposed INN List 129: amylin analogue

Regulatory record

World Health Organization. Proposed International Nonproprietary Names: List 129. WHO Drug Information, Vol. 37, No. 2, 2023.

Petrelintide appears with the descriptor "amylin analogue" and a chemical name that includes a 19-carboxynonadecanoyl acyl group and a 3,8-anhydro (lactam) bridge, which fits the acylated peptide in the PubChem record. The list prints no development codes.

Participants / model
Chemical and regulatory description, not a clinical population
Treatment
Subcutaneous acylated peptide
Follow-up
Not applicable
Study design
WHO proposed INN list
Funding
not stated in the source

The list prints no development codes, so the link between the name and the codes ZP8396 and RO7895515 rests on the registry and the journal papers.

Read the original source
2025 chemistry paper: potent, stable, long-acting amylin analogue, near-neutral pH

Chemical identity record

Fischer Munch H et al. J Med Chem. 2025;68(22):23925-23940. PMID 41217931.

A 2025 medicinal chemistry paper from Zealand Pharma, with Boehringer Ingelheim co-authors, describes petrelintide as a potent, chemically stable, long-acting analogue of human amylin that can be formulated at about neutral pH, with an aim of allowing co-formulation with marketed peptide drugs. The abstract gives no clinical efficacy data.

Participants / model
Preclinical and chemistry description, not a clinical population
Treatment
Peptide design and formulation
Follow-up
Not applicable
Study design
Peer-reviewed medicinal chemistry paper (abstract only)
Funding
not stated in the source

Developer authors. The abstract gives no clinical efficacy data.

Read the original source
Roche release, 12 March 2025: petrelintide partnership with Zealand Pharma

Regulatory record

Roche. Media release dated 12 March 2025: exclusive collaboration and licensing agreement with Zealand Pharma to co-develop and co-commercialise petrelintide.

Roche announced an exclusive collaboration and licensing agreement with Zealand Pharma to co-develop and co-commercialise petrelintide, as a standalone therapy and as a fixed-dose combination with Roche's CT-388. The release described petrelintide as in phase 2 at that date, with co-commercialisation in the US and Europe and exclusive Roche commercialisation rights in the rest of the world.

Participants / model
Not a clinical population
Treatment
Not applicable
Follow-up
Statement dated 12 March 2025
Study design
Company media release
Funding
not stated in the source

A company statement dated 12 March 2025. Financial terms are not repeated here.

Read the original source
Phase 1: two randomized trials, half-life about 10 days, weight down by up to 8.6% at 16 weeks

Randomized controlled trial

Brændholt Olsen M et al. Diabetes Obes Metab. 2026;28(7):5915-5925. PMID 42017294.

Two randomized, double-blind, placebo-controlled phase 1 trials gave subcutaneous petrelintide at 0.04 to 2.4 mg and one 0.35 mg intravenous dose (single ascending dose), six weekly 0.6 and 1.2 mg doses (multiple ascending dose part 1), and 16 weekly doses escalated to targets of 2.4, 4.8 and 9.0 mg (part 2). There were no serious or severe treatment-emergent adverse events. The most common events were gastrointestinal and mostly mild, and one participant stopped for them. In part 2, nausea occurred in 16.7 to 33.3% of petrelintide participants versus 16.7% of placebo participants. Petrelintide was absorbed slowly with a half-life of about 10 days and dose-proportional steady state, and body weight fell by up to 8.6% after 16 weeks.

Participants / model
Adults of normal weight or overweight (single dose and multiple dose part 1) and adults with overweight or obesity (part 2); participant numbers not given in the abstract
Treatment
Subcutaneous petrelintide once weekly, and a single intravenous dose
Follow-up
Single dose; six weekly doses (part 1); 16 weekly doses (part 2)
Study design
Two randomized, double-blind, placebo-controlled phase 1 trials
Funding
Zealand Pharma sponsored and funded the work

The abstract does not give participant numbers. The 8.6% is an upper bound ("up to"), not a mean.

Read the original source
ZUPREME-1: 493 randomized, mean weight down 7.9 to 9.8% at 28 weeks, up to 10.7% by week 42

Randomized controlled trial

Garvey WT et al. Lancet Diabetes Endocrinol. 2026. PMID 42810355.

ZUPREME-1 (NCT06662539) randomized 493 adults (485 dosed) 5:1 to once-weekly petrelintide maintenance doses of 1.0 to 9.0 mg or placebo for 42 weeks including dose escalation, at 32 sites in Poland, Romania and the USA. On the efficacy estimand, mean weight fell 7.9% (1.0 mg), 7.9% (2.5 mg), 9.8% (5.0 mg), 9.3% (7.0 mg) and 9.4% (9.0 mg) at 28 weeks, versus 1.7% with placebo, with estimated differences from placebo of 6.2, 6.2, 8.1, 7.7 and 7.7 percentage points. Weight kept falling to week 42, with reductions of up to 10.7% with petrelintide. Nausea occurred in 79 (20%) of 404 petrelintide participants versus 5 (6%) of 81 on placebo, vomiting in 12 (3%) versus 5 (6%), diarrhea in 30 (7%) versus 6 (7%) and constipation in 28 (7%) versus 3 (4%). No deaths were reported.

Participants / model
493 randomized adults (485 dosed) without type 2 diabetes with a BMI of at least 30, or at least 27 with hypertension or dyslipidemia; mean baseline weight 107.1 kg, BMI 36.7
Treatment
Subcutaneous petrelintide once weekly, maintenance doses of 1.0 to 9.0 mg, or placebo
Follow-up
42 weeks including dose escalation; primary endpoint at 28 weeks
Study design
Randomized, placebo-controlled phase 2 trial, 5:1, 32 sites in Poland, Romania and the USA
Funding
Funded by Zealand Pharma; 5 of the 11 authors are Zealand employees

Published online ahead of print on 29 September 2026. Only the abstract was available. The 10.7% is the abstract's upper bound: it names no dose or estimand and gives no placebo figure at week 42, so it is not a mean across doses and not a placebo-adjusted difference. Serious adverse event counts, discontinuation rates, heart rate, blood pressure and body composition are not in the abstract.

Read the original source
Company statement, 7 October 2026: ZUPREME-2 in type 2 diabetes, up to 9.2% at 28 weeks

Clinical trial

Zealand Pharma. Company announcement No. 54 / 2026, dated 7 October 2026: topline results from ZUPREME-2 (NCT06926842).

The company reported results from 220 US participants with overweight or obesity and type 2 diabetes on metformin with or without an SGLT2 inhibitor. At week 28, it reported up to 9.2% mean weight reduction (range 7.4 to 9.2% across the three petrelintide arms) versus 2.0% with placebo on the efficacy estimand, and described the treatment-regimen estimand as largely consistent without giving figures. HbA1c fell by up to 0.65% versus a 0.23% rise on placebo, and the placebo-adjusted fall was 0.61 to 0.88 percentage points. Discontinuation for gastrointestinal adverse events was 1.9% versus 1.7%. The company reported no unexpected safety signals.

Participants / model
Adults with overweight or obesity and type 2 diabetes on metformin with or without an SGLT2 inhibitor (220 US participants per the announcement; the registry lists 221 enrolled)
Treatment
Subcutaneous petrelintide once weekly, three dose arms (doses not stated in the announcement), or placebo
Follow-up
28 weeks
Study design
Company topline announcement of a randomized phase 2 trial; not peer reviewed
Funding
not stated in the source

A company statement dated 7 October 2026. Full results had not been presented or published, and the registry has no posted results. Figures given as "up to" are the best arm, not a mean across arms.

Read the original source
Registry: three Roche phase 3 trials, recruiting, no results

Trial registry record

ClinicalTrials.gov. NCT07843485, with related records NCT07843498 and NCT07843472 (Hoffmann-La Roche).

Three Roche-sponsored, randomized, quadruple-masked, placebo-controlled phase 3 trials were first posted on 28 September 2026 with start dates of 30 September 2026, a drug-device combination product and a primary outcome of percent change in body weight from baseline to week 64: NCT07843498 (obesity or overweight with a weight-related comorbidity, no type 2 diabetes, estimated 3900, primary completion 21 December 2028), NCT07843485 (with type 2 diabetes, estimated 600, 20 October 2028) and NCT07843472 (with established cardiovascular disease, estimated 2500, 28 July 2030). All three are recruiting with no results. A company announcement dated 7 October 2026 says first participants have started treatment. A registration is not an outcome.

Participants / model
Adults with overweight or obesity (planned populations)
Treatment
Subcutaneous petrelintide once weekly, drug-device combination product
Follow-up
Primary outcome at week 64 (planned)
Study design
Official trial registry
Funding
not stated in the source

Registrations and estimated dates, not outcomes. No phase 3 results exist.

Read the original source
Registry: petrelintide plus enicepatide, 486 planned, not yet recruiting

Trial registry record

ClinicalTrials.gov. NCT07589686 (Hoffmann-La Roche).

NCT07589686 (Roche) is a randomized, double-blind phase 2 of petrelintide with enicepatide (also coded RO7795068, CT-388 and RG6640) against each alone and placebo, estimated 486 adults, primary outcome percent change in body weight to week 40. It was listed as not yet recruiting at the 9 September 2026 update, with no results.

Participants / model
Adults with obesity or overweight (planned)
Treatment
Subcutaneous once weekly, two peptides
Follow-up
Primary outcome at week 40 (planned)
Study design
Official trial registry
Funding
not stated in the source

A registration, not an outcome.

Read the original source
Registry: renal, hepatic and drug product studies, no posted results

Trial registry record

ClinicalTrials.gov. NCT07076030, with related records NCT07338214 and NCT07682818.

Clinical pharmacology studies are registered with no posted results: renal impairment (NCT07076030, 39 participants, completed), drug product concentrations (NCT07338214, 48, completed) and hepatic impairment (NCT07682818, 36, recruiting). No public organ-impairment dosing data were found in the records reviewed.

Participants / model
Not a clinical population
Treatment
Subcutaneous
Follow-up
Not applicable
Study design
Official trial registry
Funding
not stated in the source

Registrations, not outcomes.

Read the original source

Why is Petrelintide in B tier?

B fits a drug with a published randomized phase 2 trial and phase 1 data but no phase 3 result. The weight loss in 493 adults is substantial, but there is no approval record, no independent replication and no long-term safety data, and the second phase 2 in type 2 diabetes is known only from a company announcement.