Enicepatide

updated

Enicepatide (CT-388, RO7795068, RG6640) is Roche's investigational injectable that the WHO describes as a dual agonist of the GIP and GLP-1 receptors, and its only peer-reviewed human data are a four-week phase 1 study (-4.7% to -8.0% at day 29 versus -0.5% on placebo). The 18.3% at 48 weeks that circulates is a company-reported placebo-adjusted treatment-regimen figure at 24 mg in a 469-person phase 2 trial, and the efficacy estimand figure is 22.5%. Phase 3 is not starting: it has been recruiting since March 2026.

GIP and GLP-1 receptor dual agonist peptide (investigational)

  • Enicepatide is a WHO Proposed INN (List 133, 2025) for a dual GIP and GLP-1 receptor agonist, formula C226H345FN48O67, CAS 2869147-44-2. Registry records list CT-388, RO7795068 and RG6640 as other names, and Roche is the developer.
  • In a phase 1 study (NCT04838405) in otherwise healthy adults with overweight or obesity, mean percent change in body weight from baseline to day 29 was -4.7% to -8.0% across doses versus -0.5% on placebo. It is the only peer-reviewed human report found.
  • Roche reported on 27 January 2026 that in a 469-person phase 2 trial the 24 mg group had placebo-adjusted weight loss of 22.5% by the efficacy estimand and 18.3% by the treatment-regimen estimand at week 48 (P<0.001). Both are company statements, not peer reviewed.
  • In a separate phase 2 trial in 447 adults with type 2 diabetes and overweight or obesity, Roche reported on 22 September 2026 that HbA1c fell 2.65% from a baseline of 8.1% at 24 mg and mean weight loss was 15.5% at 48 weeks. This is a different trial and population from the obesity figures.
  • ENITH-1 (NCT07351045, estimated 2,000 adults without type 2 diabetes) and ENITH-2 (NCT07351058, estimated 1,600 with type 2 diabetes) started in March 2026 and were Recruiting at the September 2026 registry update. Neither has posted results.
  • No regulatory approval was found: on 10 October 2026 openFDA Drugs@FDA returned no application records and DailyMed returned no labels. A PubMed search the same day found no peer-reviewed report of either phase 2 trial.

What is enicepatide, and is it approved anywhere?

Enicepatide is the WHO Proposed INN for a synthetic peptide described as a dual GIP and GLP-1 receptor agonist, and it is the same compound as CT-388, developed by Roche. No regulatory approval was found: openFDA and DailyMed searches on 10 October 2026 returned no application records and no labels.

Enicepatide is a WHO Proposed INN (List 133, WHO Drug Information Vol. 39 No. 2, 2025), described as a dual gastric inhibitory polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) receptor agonist, antidiabetic. The entry lists the formula C226H345FN48O67 and CAS 2869147-44-2. WHO INN entries carry no company codes. A PubChem name search for enicepatide and CT-388 returned no compound record on 10 October 2026.

Enicepatide is CT-388, and Roche is the developer. The Hoffmann-La Roche sponsored phase 3 record NCT07351045 lists the intervention Enicepatide with the other names RO7795068, CT-388 and RG6640. The phase 2 record NCT06525935, sponsored by Carmot Therapeutics, lists the same names. Roche's release of 1 June 2026 writes enicepatide (CT-388). The authors of the phase 1 paper are Genentech employees (previously Carmot Therapeutics), and its disclosures describe Carmot as now a member of the Roche Group.

No regulatory approval was found. On 10 October 2026 openFDA Drugs@FDA returned no application records for enicepatide, and a DailyMed search returned no labels. Roche describes enicepatide as investigational in every release read.

WHO Proposed INN List 133 (2025): dual GIP and GLP-1 receptor agonist

Chemical identity record

World Health Organization. Proposed International Nonproprietary Names: List 133. WHO Drug Information, Vol. 39, No. 2, 2025.

Enicepatide is described as a dual gastric inhibitory polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) receptor agonist, antidiabetic. The entry lists the formula C226H345FN48O67 and CAS 2869147-44-2. WHO INN entries carry no company codes. A PubChem name search for enicepatide and CT-388 returned no compound record on 10 October 2026.

Participants / model
Molecular identity, not a clinical population
Treatment
Synthetic peptide, subcutaneous
Follow-up
Not applicable
Study design
Official WHO nomenclature record (Proposed INN list)
Funding
not stated in the source

The link between the INN and the code CT-388 rests on the registry records and Roche's release, because the WHO list carries no codes.

Read the original source
Registry records: Enicepatide, RO7795068, CT-388 and RG6640 as one compound, Roche developer

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Record NCT07351045 (ENITH-1), with the phase 2 record NCT06525935. Read on 10 October 2026.

The Hoffmann-La Roche sponsored phase 3 record NCT07351045 lists the intervention Enicepatide with other names RO7795068, CT-388 and RG6640. The phase 2 record NCT06525935, sponsored by Carmot Therapeutics, lists the same names. Roche's release of 1 June 2026 writes enicepatide (CT-388). The phase 1 paper's authors are Genentech employees (previously Carmot Therapeutics), and its disclosures describe Carmot as now a member of the Roche Group.

Participants / model
Sponsor and code identity, not a clinical population
Treatment
Not applicable
Follow-up
Not applicable
Study design
Trial registry records
Funding
Sponsor of NCT07351045: Hoffmann-La Roche; sponsor of NCT06525935: Carmot Therapeutics

Enicepatide and CT-388 are treated as one compound on this page. The year of the Carmot acquisition is not stated.

Read the original source
Company release, 1 June 2026: investigational; no US application or label found

Regulatory record

Roche press release dated 1 June 2026. openFDA Drugs@FDA and DailyMed searches run on 10 October 2026.

No regulatory approval was found. On 10 October 2026 openFDA Drugs@FDA returned no application records for enicepatide and a DailyMed search returned no labels. Roche describes enicepatide as investigational in every release read. The release writes enicepatide (CT-388).

Participants / model
Not a clinical population
Treatment
Not applicable
Follow-up
Release dated 1 June 2026; searches run on 10 October 2026
Study design
Company press release and US regulator database searches
Funding
not stated in the source

A search result shows what the databases held on that date.

Read the original source

What has been published, and what did the phase 1 study find?

One peer-reviewed report exists: a phase 1 study in otherwise healthy adults with overweight or obesity. Mean percent change in body weight from baseline to day 29 was -4.7% to -8.0% across doses versus -0.5% on placebo. CT-388 was generally well tolerated, with most events mild or moderate.

The phase 1 trial (NCT04838405) was randomized, double-blind and placebo-controlled in otherwise healthy participants with overweight or obesity. It gave single subcutaneous doses of 0.5 to 7.5 mg or four once-weekly doses of 5 to 12 mg. Mean percent change in body weight from baseline to day 29 was -4.7% to -8.0% across CT-388 doses versus -0.5% on placebo. These are changes from baseline in each group, not placebo-adjusted differences, over a four-week period.

CT-388 was generally well tolerated, most treatment-emergent events were mild or moderate, and the pharmacokinetics supported once-weekly dosing. The paper also reports cell, mouse and monkey work, and it is authored by Genentech and former Carmot staff.

A PubMed search on 10 October 2026 for enicepatide OR CT-388 OR CT388 OR RO7795068 returned 3 records: the phase 1 paper (PMID 41319798), a narrative review of GLP-1 co-agonists and cardiac effects (PMID 42768195), and a 2021 review of emerging GLP-1 agonists (PMID 34176426). A ClinicalTrials.gov search for the same names returned 8 records (2 phase 1, 3 phase 2, 3 phase 3) with no posted results on any, including the two completed phase 2 trials (NCT06525935 and NCT06628362). No peer-reviewed report of either phase 2 trial was found, so every phase 2 number on this page is a company statement.

Phase 1: healthy adults with overweight or obesity, -4.7% to -8.0% at day 29 versus -0.5%

Clinical trial

Chakravarthy MV et al. Mol Metab. 2026;103:102291. PMID 41319798.

Mean percent change in body weight from baseline to day 29 was -4.7% to -8.0% across CT-388 doses versus -0.5% on placebo. CT-388 was generally well tolerated, most treatment-emergent events were mild or moderate, and the pharmacokinetics supported once-weekly dosing. The paper also reports cell, mouse and monkey work; it is authored by Genentech and former Carmot staff.

Participants / model
Otherwise healthy adults with overweight or obesity
Treatment
Subcutaneous CT-388: single doses of 0.5 to 7.5 mg or four once-weekly doses of 5 to 12 mg, or placebo
Follow-up
Single doses; four weekly doses; weight change to day 29
Study design
Randomized, double-blind, placebo-controlled phase 1 trial with preclinical data (NCT04838405)
Funding
not stated in the source

The weight figures are mean changes from baseline over four weeks and are not placebo-adjusted. The sample size and half-life are not given in the sources reviewed.

Read the original source
Searches, 10 October 2026: 3 PubMed records, no peer-reviewed phase 2 report

PubMed search record

PubMed search for enicepatide OR CT-388 OR CT388 OR RO7795068, run on 10 October 2026 (3 records). ClinicalTrials.gov search for the same names run the same day (8 records).

PubMed returned 3 records: the phase 1 paper (PMID 41319798), a narrative review of GLP-1 co-agonists and cardiac effects (PMID 42768195) and a 2021 review of emerging GLP-1 agonists (PMID 34176426). ClinicalTrials.gov returned 8 records (2 phase 1, 3 phase 2, 3 phase 3) with no posted results on any; the two completed phase 2 trials (NCT06525935 and NCT06628362) have none. In the records reviewed there is no peer-reviewed report of either phase 2 trial, and all phase 2 numbers are company statements.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Literature and registry searches
Funding
not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study exists.

Read the original source

What has Roche reported from the phase 2 trial in obesity?

At 24 mg in a 469-person phase 2 trial, Roche reported placebo-adjusted weight loss of 22.5% by the efficacy estimand and 18.3% by the treatment-regimen estimand at week 48. The figures come from press releases and a slide deck, dated 27 January, 8 June and 22 September 2026, and are not peer reviewed.

On 27 January 2026 Roche reported the phase 2 trial CT388-103 (NCT06525935), a randomized, double-blind, placebo-controlled trial in 469 adults in the United States with obesity, or overweight with a comorbidity, without type 2 diabetes. It had five dosing cohorts up to 24 mg once weekly for 48 weeks. At 24 mg the placebo-adjusted weight loss was 22.5% by the efficacy estimand and 18.3% by the treatment-regimen estimand (P<0.001). At week 48 on 24 mg, 95.7% lost at least 5%, 87% at least 10%, 47.8% at least 20% and 26.1% at least 30% of body weight. The estimand for these thresholds is not stated in the sources reviewed.

The 18.3% is therefore a placebo-adjusted treatment-regimen figure at the 24 mg dose, not an unadjusted weight loss, and Roche's headline is the larger 22.5%.

Roche's investor event slides of 8 June 2026 (an American Diabetes Association late-breaker by Lingvay and colleagues) give more detail. By the efficacy estimand, mean change in the 24 mg arm was -22.7% at week 48 versus -0.2% on placebo, an estimated treatment difference of -22.5% (95% CI -25.3 to -19.8). By the treatment-regimen estimand, treatment differences versus placebo at week 48 were -5.0 (4 mg), -10.7 (8 mg), -11.7 (12 mg), -13.4 (16 mg) and -18.3 (24 mg; 95% CI -21.6 to -14.9). These figures were read from the text of the slide deck, not from a paper.

Company statement, 27 January 2026: phase 2, 469 adults, 22.5% and 18.3% at 24 mg, not peer reviewed

Regulatory record

Roche press release dated 27 January 2026 on the phase 2 trial CT388-103.

In the phase 2 trial CT388-103 (NCT06525935; randomized, double-blind, placebo-controlled; 469 adults with obesity, or overweight with a comorbidity, without type 2 diabetes; five dosing cohorts up to 24 mg once weekly; 48 weeks), the placebo-adjusted weight loss at 24 mg was 22.5% by the efficacy estimand and 18.3% by the treatment-regimen estimand (P<0.001). At week 48 on 24 mg, 95.7% lost at least 5%, 87% at least 10%, 47.8% at least 20% and 26.1% at least 30%. Treatment discontinuation due to adverse events was 5.9% in CT-388 arms and 1.3% on placebo. The 18.3% is a placebo-adjusted treatment-regimen figure at the 24 mg dose, not an unadjusted weight loss, and Roche's headline is the larger 22.5%.

Participants / model
469 adults with obesity or overweight, without diabetes, in the United States
Treatment
Weekly subcutaneous enicepatide (CT-388) up to 24 mg, five dosing cohorts
Follow-up
48 weeks
Study design
Company press release on a phase 2 trial; not peer reviewed
Funding
not stated in the source

Company statement dated 27 January 2026. The estimand for the weight-loss thresholds is not stated in the sources reviewed.

Read the original source
Company slides, 8 June 2026: efficacy and treatment-regimen estimands, adverse events at 24 mg

Regulatory record

Roche investor event slides dated 8 June 2026, reporting the American Diabetes Association late-breaker by Lingvay et al.

By the efficacy estimand, mean change in the 24 mg arm was -22.7% at week 48 versus -0.2% on placebo, with an estimated treatment difference of -22.5% (95% CI -25.3 to -19.8). Treatment-regimen estimand treatment differences versus placebo at week 48 were -5.0 (4 mg), -10.7 (8 mg), -11.7 (12 mg), -13.4 (16 mg) and -18.3 (24 mg; 95% CI -21.6 to -14.9). Adverse events by maximum dose reached (placebo, N=79, versus 24 mg, N=76): any adverse event 64% versus 86%, serious adverse events 0% versus 5%, nausea 19% versus 46%, diarrhea 10% versus 32% and vomiting 0% versus 21%; no fatal events and no grade 4 or 5 events.

Participants / model
Adults with obesity or overweight, without diabetes
Treatment
Weekly subcutaneous enicepatide, 4 to 24 mg
Follow-up
48 weeks
Study design
Company investor slide deck; not peer reviewed
Funding
not stated in the source

The figures were read from the slide text layer, with column alignment taken from a table extraction rather than the rendered image. The poster or abstract was not retrieved, so the safety figures should be read with caution.

Read the original source

What has Roche reported from the phase 2 trial in type 2 diabetes?

In a 447-person phase 2 trial in adults with type 2 diabetes and overweight or obesity, Roche reported on 22 September 2026 that HbA1c fell 2.65% from a baseline of 8.1% at 24 mg, 90% reached an HbA1c of 6.5% or lower, and mean weight loss was 15.5% at 48 weeks. This is a different trial from the obesity figures.

Roche's press release of 22 September 2026 describes the phase 2 trial CT-388-104 (NCT06628362), randomized, double-blind and placebo-controlled, in 447 adults with type 2 diabetes and overweight or obesity over 48 weeks. At 24 mg, HbA1c fell 2.65% from a baseline of 8.1%, 90% reached an HbA1c of 6.5% or lower, and mean weight loss was 15.5% at 48 weeks. Discontinuation due to adverse events was 2.0% in the enicepatide arms and 0.0% on placebo. The sources reviewed do not state the estimand or whether the 15.5% is placebo-adjusted.

This is a different trial and population from the 22.5% and 18.3% figures in obesity, and it should not be placed next to them as the same result. It is a company statement without a peer-reviewed report.

Company statement, 22 September 2026: phase 2 in type 2 diabetes, 447 adults, not peer reviewed

Regulatory record

Roche press release dated 22 September 2026 on the phase 2 trial CT-388-104 and the enicepatide phase 3 program.

In the phase 2 trial CT-388-104 (NCT06628362; randomized, double-blind, placebo-controlled; 447 adults with type 2 diabetes and overweight or obesity; 48 weeks), HbA1c at 24 mg fell 2.65% from a baseline of 8.1%, 90% reached an HbA1c of 6.5% or lower, and mean weight loss was 15.5% at 48 weeks. Discontinuation due to adverse events was 2.0% in enicepatide arms and 0.0% on placebo. The release calls ENITH-1 and ENITH-2 two ongoing phase 3 studies and says a glycemic-control phase 3 program and cardiovascular outcomes trials are planned for the first half of 2027.

Participants / model
447 adults with type 2 diabetes and overweight or obesity
Treatment
Weekly subcutaneous enicepatide up to 24 mg
Follow-up
48 weeks
Study design
Company press release on a phase 2 trial; not peer reviewed
Funding
not stated in the source

A different trial and population from the obesity figures of 22.5% and 18.3%, and they should not be placed next to each other as the same result. The estimand and placebo adjustment of the 15.5% are not stated in the sources reviewed.

Read the original source

Is phase 3 starting, and does it have results?

Phase 3 has already started and has no results. ENITH-1 (estimated 2,000 adults without type 2 diabetes, started 16 March 2026) and ENITH-2 (estimated 1,600 with type 2 diabetes, started 23 March 2026) were both Recruiting at the September 2026 registry update.

ENITH-1 (NCT07351045, adults without type 2 diabetes, estimated 2,000, start 16 March 2026, primary endpoint percent change in body weight at week 72) and ENITH-2 (NCT07351058, with type 2 diabetes, estimated 1,600, start 23 March 2026) are both Recruiting as of the September 2026 registry update, with Hoffmann-La Roche as sponsor. Both give weekly subcutaneous enicepatide versus placebo over 72 weeks.

Roche's release of 22 September 2026 calls them two ongoing phase 3 studies and says a glycemic-control phase 3 program and cardiovascular outcomes trials are planned for the first half of 2027. Neither trial has posted results. Registrations without posted results are not outcomes.

Registry: ENITH-1 and ENITH-2, Recruiting since March 2026, no posted results

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Record NCT07351058 (ENITH-2), with NCT07351045 (ENITH-1). Read on 10 October 2026, showing the September 2026 update.

ENITH-1 (NCT07351045, adults without type 2 diabetes, estimated 2,000, start 16 March 2026, primary endpoint percent change in body weight at week 72) and ENITH-2 (NCT07351058, with type 2 diabetes, estimated 1,600, start 23 March 2026) are both Recruiting as of the September 2026 verification, with Hoffmann-La Roche as sponsor. Neither trial has posted results. Registrations without posted results are not outcomes.

Participants / model
Adults with obesity or overweight, without and with type 2 diabetes (planned)
Treatment
Weekly subcutaneous enicepatide versus placebo, 72 weeks
Follow-up
72 weeks per participant
Study design
Registered phase 3 design and status only
Funding
Sponsor: Hoffmann-La Roche

Registry design and status only. No efficacy or safety result from either trial is public.

Read the original source
Company statement, 22 September 2026: phase 2 in type 2 diabetes, 447 adults, not peer reviewed

Regulatory record

Roche press release dated 22 September 2026 on the phase 2 trial CT-388-104 and the enicepatide phase 3 program.

In the phase 2 trial CT-388-104 (NCT06628362; randomized, double-blind, placebo-controlled; 447 adults with type 2 diabetes and overweight or obesity; 48 weeks), HbA1c at 24 mg fell 2.65% from a baseline of 8.1%, 90% reached an HbA1c of 6.5% or lower, and mean weight loss was 15.5% at 48 weeks. Discontinuation due to adverse events was 2.0% in enicepatide arms and 0.0% on placebo. The release calls ENITH-1 and ENITH-2 two ongoing phase 3 studies and says a glycemic-control phase 3 program and cardiovascular outcomes trials are planned for the first half of 2027.

Participants / model
447 adults with type 2 diabetes and overweight or obesity
Treatment
Weekly subcutaneous enicepatide up to 24 mg
Follow-up
48 weeks
Study design
Company press release on a phase 2 trial; not peer reviewed
Funding
not stated in the source

A different trial and population from the obesity figures of 22.5% and 18.3%, and they should not be placed next to each other as the same result. The estimand and placebo adjustment of the 15.5% are not stated in the sources reviewed.

Read the original source

Does enicepatide give 18.3% weight loss at 48 weeks, and is phase 3 starting?

The 18.3% is real but is a company-reported placebo-adjusted treatment-regimen figure at 24 mg, and the efficacy estimand figure is 22.5%. Phase 3 is not starting: it has been recruiting since March 2026. The compound is a dual GIP and GLP-1 receptor agonist per the WHO, developed by Roche.

The claim is that enicepatide (CT-388, Roche) is a GLP-1/GIP dual agonist with 18.3% weight loss at 48 weeks in phase 2, and that phase 3 is starting. The WHO record, the registry names and Roche's releases confirm the code, the INN and the developer.

The 18.3% is the placebo-adjusted treatment-regimen estimand figure at the 24 mg dose at week 48, from a company press release. It is not an unadjusted weight loss. By the efficacy estimand the placebo-adjusted figure is 22.5%, and the mean change in the 24 mg arm was -22.7% versus -0.2% on placebo. Neither figure has a peer-reviewed report.

Phase 3 is out of date as a description: ENITH-1 and ENITH-2 began in March 2026 and were Recruiting at the September 2026 update, with no results.

WHO Proposed INN List 133 (2025): dual GIP and GLP-1 receptor agonist

Chemical identity record

World Health Organization. Proposed International Nonproprietary Names: List 133. WHO Drug Information, Vol. 39, No. 2, 2025.

Enicepatide is described as a dual gastric inhibitory polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) receptor agonist, antidiabetic. The entry lists the formula C226H345FN48O67 and CAS 2869147-44-2. WHO INN entries carry no company codes. A PubChem name search for enicepatide and CT-388 returned no compound record on 10 October 2026.

Participants / model
Molecular identity, not a clinical population
Treatment
Synthetic peptide, subcutaneous
Follow-up
Not applicable
Study design
Official WHO nomenclature record (Proposed INN list)
Funding
not stated in the source

The link between the INN and the code CT-388 rests on the registry records and Roche's release, because the WHO list carries no codes.

Read the original source
Registry records: Enicepatide, RO7795068, CT-388 and RG6640 as one compound, Roche developer

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Record NCT07351045 (ENITH-1), with the phase 2 record NCT06525935. Read on 10 October 2026.

The Hoffmann-La Roche sponsored phase 3 record NCT07351045 lists the intervention Enicepatide with other names RO7795068, CT-388 and RG6640. The phase 2 record NCT06525935, sponsored by Carmot Therapeutics, lists the same names. Roche's release of 1 June 2026 writes enicepatide (CT-388). The phase 1 paper's authors are Genentech employees (previously Carmot Therapeutics), and its disclosures describe Carmot as now a member of the Roche Group.

Participants / model
Sponsor and code identity, not a clinical population
Treatment
Not applicable
Follow-up
Not applicable
Study design
Trial registry records
Funding
Sponsor of NCT07351045: Hoffmann-La Roche; sponsor of NCT06525935: Carmot Therapeutics

Enicepatide and CT-388 are treated as one compound on this page. The year of the Carmot acquisition is not stated.

Read the original source
Company statement, 27 January 2026: phase 2, 469 adults, 22.5% and 18.3% at 24 mg, not peer reviewed

Regulatory record

Roche press release dated 27 January 2026 on the phase 2 trial CT388-103.

In the phase 2 trial CT388-103 (NCT06525935; randomized, double-blind, placebo-controlled; 469 adults with obesity, or overweight with a comorbidity, without type 2 diabetes; five dosing cohorts up to 24 mg once weekly; 48 weeks), the placebo-adjusted weight loss at 24 mg was 22.5% by the efficacy estimand and 18.3% by the treatment-regimen estimand (P<0.001). At week 48 on 24 mg, 95.7% lost at least 5%, 87% at least 10%, 47.8% at least 20% and 26.1% at least 30%. Treatment discontinuation due to adverse events was 5.9% in CT-388 arms and 1.3% on placebo. The 18.3% is a placebo-adjusted treatment-regimen figure at the 24 mg dose, not an unadjusted weight loss, and Roche's headline is the larger 22.5%.

Participants / model
469 adults with obesity or overweight, without diabetes, in the United States
Treatment
Weekly subcutaneous enicepatide (CT-388) up to 24 mg, five dosing cohorts
Follow-up
48 weeks
Study design
Company press release on a phase 2 trial; not peer reviewed
Funding
not stated in the source

Company statement dated 27 January 2026. The estimand for the weight-loss thresholds is not stated in the sources reviewed.

Read the original source
Company slides, 8 June 2026: efficacy and treatment-regimen estimands, adverse events at 24 mg

Regulatory record

Roche investor event slides dated 8 June 2026, reporting the American Diabetes Association late-breaker by Lingvay et al.

By the efficacy estimand, mean change in the 24 mg arm was -22.7% at week 48 versus -0.2% on placebo, with an estimated treatment difference of -22.5% (95% CI -25.3 to -19.8). Treatment-regimen estimand treatment differences versus placebo at week 48 were -5.0 (4 mg), -10.7 (8 mg), -11.7 (12 mg), -13.4 (16 mg) and -18.3 (24 mg; 95% CI -21.6 to -14.9). Adverse events by maximum dose reached (placebo, N=79, versus 24 mg, N=76): any adverse event 64% versus 86%, serious adverse events 0% versus 5%, nausea 19% versus 46%, diarrhea 10% versus 32% and vomiting 0% versus 21%; no fatal events and no grade 4 or 5 events.

Participants / model
Adults with obesity or overweight, without diabetes
Treatment
Weekly subcutaneous enicepatide, 4 to 24 mg
Follow-up
48 weeks
Study design
Company investor slide deck; not peer reviewed
Funding
not stated in the source

The figures were read from the slide text layer, with column alignment taken from a table extraction rather than the rendered image. The poster or abstract was not retrieved, so the safety figures should be read with caution.

Read the original source
Registry: ENITH-1 and ENITH-2, Recruiting since March 2026, no posted results

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Record NCT07351058 (ENITH-2), with NCT07351045 (ENITH-1). Read on 10 October 2026, showing the September 2026 update.

ENITH-1 (NCT07351045, adults without type 2 diabetes, estimated 2,000, start 16 March 2026, primary endpoint percent change in body weight at week 72) and ENITH-2 (NCT07351058, with type 2 diabetes, estimated 1,600, start 23 March 2026) are both Recruiting as of the September 2026 verification, with Hoffmann-La Roche as sponsor. Neither trial has posted results. Registrations without posted results are not outcomes.

Participants / model
Adults with obesity or overweight, without and with type 2 diabetes (planned)
Treatment
Weekly subcutaneous enicepatide versus placebo, 72 weeks
Follow-up
72 weeks per participant
Study design
Registered phase 3 design and status only
Funding
Sponsor: Hoffmann-La Roche

Registry design and status only. No efficacy or safety result from either trial is public.

Read the original source

How does enicepatide work, and how long does it last?

The WHO describes enicepatide as a dual agonist of the GIP and GLP-1 receptors. The phase 1 paper reports pharmacokinetics that supported once-weekly dosing, but the sources reviewed give no half-life value.

The WHO entry describes a dual gastric inhibitory polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) receptor agonist, antidiabetic, and lists a synthetic peptide with the formula C226H345FN48O67. The phase 1 paper also reports cell, mouse and monkey work, but the sources reviewed give no results from it, so nothing further about the mechanism is stated here.

The phase 1 paper reports that the pharmacokinetics supported once-weekly dosing. No half-life, Tmax or other pharmacokinetic value was retrieved from it or from the phase 2 reports, so none is entered for this page.

WHO Proposed INN List 133 (2025): dual GIP and GLP-1 receptor agonist

Chemical identity record

World Health Organization. Proposed International Nonproprietary Names: List 133. WHO Drug Information, Vol. 39, No. 2, 2025.

Enicepatide is described as a dual gastric inhibitory polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) receptor agonist, antidiabetic. The entry lists the formula C226H345FN48O67 and CAS 2869147-44-2. WHO INN entries carry no company codes. A PubChem name search for enicepatide and CT-388 returned no compound record on 10 October 2026.

Participants / model
Molecular identity, not a clinical population
Treatment
Synthetic peptide, subcutaneous
Follow-up
Not applicable
Study design
Official WHO nomenclature record (Proposed INN list)
Funding
not stated in the source

The link between the INN and the code CT-388 rests on the registry records and Roche's release, because the WHO list carries no codes.

Read the original source
Phase 1: healthy adults with overweight or obesity, -4.7% to -8.0% at day 29 versus -0.5%

Clinical trial

Chakravarthy MV et al. Mol Metab. 2026;103:102291. PMID 41319798.

Mean percent change in body weight from baseline to day 29 was -4.7% to -8.0% across CT-388 doses versus -0.5% on placebo. CT-388 was generally well tolerated, most treatment-emergent events were mild or moderate, and the pharmacokinetics supported once-weekly dosing. The paper also reports cell, mouse and monkey work; it is authored by Genentech and former Carmot staff.

Participants / model
Otherwise healthy adults with overweight or obesity
Treatment
Subcutaneous CT-388: single doses of 0.5 to 7.5 mg or four once-weekly doses of 5 to 12 mg, or placebo
Follow-up
Single doses; four weekly doses; weight change to day 29
Study design
Randomized, double-blind, placebo-controlled phase 1 trial with preclinical data (NCT04838405)
Funding
not stated in the source

The weight figures are mean changes from baseline over four weeks and are not placebo-adjusted. The sample size and half-life are not given in the sources reviewed.

Read the original source

What adverse events were reported?

In the phase 1 study, CT-388 was generally well tolerated and most events were mild or moderate. In the phase 2 obesity trial, Roche reported adverse events leading to discontinuation in 5.9% of CT-388 arms versus 1.3% on placebo, and nausea in 46% at 24 mg versus 19% on placebo.

In the phase 1 study, CT-388 was generally well tolerated and most treatment-emergent events were mild or moderate.

In the phase 2 obesity trial, Roche reported on 27 January 2026 that treatment discontinuation due to adverse events was 5.9% in the CT-388 arms and 1.3% on placebo. Its 8 June 2026 slides give adverse events by maximum dose reached (placebo, N=79, versus 24 mg, N=76): any adverse event 64% versus 86%, serious adverse events 0% versus 5%, nausea 19% versus 46%, diarrhea 10% versus 32% and vomiting 0% versus 21%. The slides report no fatal events and no grade 4 or 5 events.

The slide figures were read from the text of an investor deck, and no poster or abstract was retrieved to compare them with, so they should be read with caution. In the type 2 diabetes phase 2 trial, Roche reported discontinuation due to adverse events of 2.0% in the enicepatide arms and 0.0% on placebo. No peer-reviewed safety report exists, and no phase 3 safety data are public.

Phase 1: healthy adults with overweight or obesity, -4.7% to -8.0% at day 29 versus -0.5%

Clinical trial

Chakravarthy MV et al. Mol Metab. 2026;103:102291. PMID 41319798.

Mean percent change in body weight from baseline to day 29 was -4.7% to -8.0% across CT-388 doses versus -0.5% on placebo. CT-388 was generally well tolerated, most treatment-emergent events were mild or moderate, and the pharmacokinetics supported once-weekly dosing. The paper also reports cell, mouse and monkey work; it is authored by Genentech and former Carmot staff.

Participants / model
Otherwise healthy adults with overweight or obesity
Treatment
Subcutaneous CT-388: single doses of 0.5 to 7.5 mg or four once-weekly doses of 5 to 12 mg, or placebo
Follow-up
Single doses; four weekly doses; weight change to day 29
Study design
Randomized, double-blind, placebo-controlled phase 1 trial with preclinical data (NCT04838405)
Funding
not stated in the source

The weight figures are mean changes from baseline over four weeks and are not placebo-adjusted. The sample size and half-life are not given in the sources reviewed.

Read the original source
Company statement, 27 January 2026: phase 2, 469 adults, 22.5% and 18.3% at 24 mg, not peer reviewed

Regulatory record

Roche press release dated 27 January 2026 on the phase 2 trial CT388-103.

In the phase 2 trial CT388-103 (NCT06525935; randomized, double-blind, placebo-controlled; 469 adults with obesity, or overweight with a comorbidity, without type 2 diabetes; five dosing cohorts up to 24 mg once weekly; 48 weeks), the placebo-adjusted weight loss at 24 mg was 22.5% by the efficacy estimand and 18.3% by the treatment-regimen estimand (P<0.001). At week 48 on 24 mg, 95.7% lost at least 5%, 87% at least 10%, 47.8% at least 20% and 26.1% at least 30%. Treatment discontinuation due to adverse events was 5.9% in CT-388 arms and 1.3% on placebo. The 18.3% is a placebo-adjusted treatment-regimen figure at the 24 mg dose, not an unadjusted weight loss, and Roche's headline is the larger 22.5%.

Participants / model
469 adults with obesity or overweight, without diabetes, in the United States
Treatment
Weekly subcutaneous enicepatide (CT-388) up to 24 mg, five dosing cohorts
Follow-up
48 weeks
Study design
Company press release on a phase 2 trial; not peer reviewed
Funding
not stated in the source

Company statement dated 27 January 2026. The estimand for the weight-loss thresholds is not stated in the sources reviewed.

Read the original source
Company slides, 8 June 2026: efficacy and treatment-regimen estimands, adverse events at 24 mg

Regulatory record

Roche investor event slides dated 8 June 2026, reporting the American Diabetes Association late-breaker by Lingvay et al.

By the efficacy estimand, mean change in the 24 mg arm was -22.7% at week 48 versus -0.2% on placebo, with an estimated treatment difference of -22.5% (95% CI -25.3 to -19.8). Treatment-regimen estimand treatment differences versus placebo at week 48 were -5.0 (4 mg), -10.7 (8 mg), -11.7 (12 mg), -13.4 (16 mg) and -18.3 (24 mg; 95% CI -21.6 to -14.9). Adverse events by maximum dose reached (placebo, N=79, versus 24 mg, N=76): any adverse event 64% versus 86%, serious adverse events 0% versus 5%, nausea 19% versus 46%, diarrhea 10% versus 32% and vomiting 0% versus 21%; no fatal events and no grade 4 or 5 events.

Participants / model
Adults with obesity or overweight, without diabetes
Treatment
Weekly subcutaneous enicepatide, 4 to 24 mg
Follow-up
48 weeks
Study design
Company investor slide deck; not peer reviewed
Funding
not stated in the source

The figures were read from the slide text layer, with column alignment taken from a table extraction rather than the rendered image. The poster or abstract was not retrieved, so the safety figures should be read with caution.

Read the original source
Company statement, 22 September 2026: phase 2 in type 2 diabetes, 447 adults, not peer reviewed

Regulatory record

Roche press release dated 22 September 2026 on the phase 2 trial CT-388-104 and the enicepatide phase 3 program.

In the phase 2 trial CT-388-104 (NCT06628362; randomized, double-blind, placebo-controlled; 447 adults with type 2 diabetes and overweight or obesity; 48 weeks), HbA1c at 24 mg fell 2.65% from a baseline of 8.1%, 90% reached an HbA1c of 6.5% or lower, and mean weight loss was 15.5% at 48 weeks. Discontinuation due to adverse events was 2.0% in enicepatide arms and 0.0% on placebo. The release calls ENITH-1 and ENITH-2 two ongoing phase 3 studies and says a glycemic-control phase 3 program and cardiovascular outcomes trials are planned for the first half of 2027.

Participants / model
447 adults with type 2 diabetes and overweight or obesity
Treatment
Weekly subcutaneous enicepatide up to 24 mg
Follow-up
48 weeks
Study design
Company press release on a phase 2 trial; not peer reviewed
Funding
not stated in the source

A different trial and population from the obesity figures of 22.5% and 18.3%, and they should not be placed next to each other as the same result. The estimand and placebo adjustment of the 15.5% are not stated in the sources reviewed.

Read the original source

Why does enicepatide sit in C tier?

The only peer-reviewed human data are a four-week phase 1 study. The phase 2 efficacy results exist only as Roche press releases and an investor slide deck, and gastrointestinal events were more frequent at 24 mg.

The peer-reviewed data are a four-week phase 1 study (weight change -4.7% to -8.0% at day 29 versus -0.5% on placebo). The phase 2 efficacy in 469 adults (22.5% placebo-adjusted by the efficacy estimand and 18.3% by the treatment-regimen estimand at 24 mg) and the type 2 diabetes phase 2 in 447 adults exist only as Roche press releases and an investor slide deck, with higher gastrointestinal event rates at 24 mg (nausea 46%, vomiting 21%).

Phase 3 is recruiting and has no results, and no regulatory approval was found. The code, INN and developer are confirmed.

Phase 1: healthy adults with overweight or obesity, -4.7% to -8.0% at day 29 versus -0.5%

Clinical trial

Chakravarthy MV et al. Mol Metab. 2026;103:102291. PMID 41319798.

Mean percent change in body weight from baseline to day 29 was -4.7% to -8.0% across CT-388 doses versus -0.5% on placebo. CT-388 was generally well tolerated, most treatment-emergent events were mild or moderate, and the pharmacokinetics supported once-weekly dosing. The paper also reports cell, mouse and monkey work; it is authored by Genentech and former Carmot staff.

Participants / model
Otherwise healthy adults with overweight or obesity
Treatment
Subcutaneous CT-388: single doses of 0.5 to 7.5 mg or four once-weekly doses of 5 to 12 mg, or placebo
Follow-up
Single doses; four weekly doses; weight change to day 29
Study design
Randomized, double-blind, placebo-controlled phase 1 trial with preclinical data (NCT04838405)
Funding
not stated in the source

The weight figures are mean changes from baseline over four weeks and are not placebo-adjusted. The sample size and half-life are not given in the sources reviewed.

Read the original source
Company statement, 27 January 2026: phase 2, 469 adults, 22.5% and 18.3% at 24 mg, not peer reviewed

Regulatory record

Roche press release dated 27 January 2026 on the phase 2 trial CT388-103.

In the phase 2 trial CT388-103 (NCT06525935; randomized, double-blind, placebo-controlled; 469 adults with obesity, or overweight with a comorbidity, without type 2 diabetes; five dosing cohorts up to 24 mg once weekly; 48 weeks), the placebo-adjusted weight loss at 24 mg was 22.5% by the efficacy estimand and 18.3% by the treatment-regimen estimand (P<0.001). At week 48 on 24 mg, 95.7% lost at least 5%, 87% at least 10%, 47.8% at least 20% and 26.1% at least 30%. Treatment discontinuation due to adverse events was 5.9% in CT-388 arms and 1.3% on placebo. The 18.3% is a placebo-adjusted treatment-regimen figure at the 24 mg dose, not an unadjusted weight loss, and Roche's headline is the larger 22.5%.

Participants / model
469 adults with obesity or overweight, without diabetes, in the United States
Treatment
Weekly subcutaneous enicepatide (CT-388) up to 24 mg, five dosing cohorts
Follow-up
48 weeks
Study design
Company press release on a phase 2 trial; not peer reviewed
Funding
not stated in the source

Company statement dated 27 January 2026. The estimand for the weight-loss thresholds is not stated in the sources reviewed.

Read the original source
Company slides, 8 June 2026: efficacy and treatment-regimen estimands, adverse events at 24 mg

Regulatory record

Roche investor event slides dated 8 June 2026, reporting the American Diabetes Association late-breaker by Lingvay et al.

By the efficacy estimand, mean change in the 24 mg arm was -22.7% at week 48 versus -0.2% on placebo, with an estimated treatment difference of -22.5% (95% CI -25.3 to -19.8). Treatment-regimen estimand treatment differences versus placebo at week 48 were -5.0 (4 mg), -10.7 (8 mg), -11.7 (12 mg), -13.4 (16 mg) and -18.3 (24 mg; 95% CI -21.6 to -14.9). Adverse events by maximum dose reached (placebo, N=79, versus 24 mg, N=76): any adverse event 64% versus 86%, serious adverse events 0% versus 5%, nausea 19% versus 46%, diarrhea 10% versus 32% and vomiting 0% versus 21%; no fatal events and no grade 4 or 5 events.

Participants / model
Adults with obesity or overweight, without diabetes
Treatment
Weekly subcutaneous enicepatide, 4 to 24 mg
Follow-up
48 weeks
Study design
Company investor slide deck; not peer reviewed
Funding
not stated in the source

The figures were read from the slide text layer, with column alignment taken from a table extraction rather than the rendered image. The poster or abstract was not retrieved, so the safety figures should be read with caution.

Read the original source
Company statement, 22 September 2026: phase 2 in type 2 diabetes, 447 adults, not peer reviewed

Regulatory record

Roche press release dated 22 September 2026 on the phase 2 trial CT-388-104 and the enicepatide phase 3 program.

In the phase 2 trial CT-388-104 (NCT06628362; randomized, double-blind, placebo-controlled; 447 adults with type 2 diabetes and overweight or obesity; 48 weeks), HbA1c at 24 mg fell 2.65% from a baseline of 8.1%, 90% reached an HbA1c of 6.5% or lower, and mean weight loss was 15.5% at 48 weeks. Discontinuation due to adverse events was 2.0% in enicepatide arms and 0.0% on placebo. The release calls ENITH-1 and ENITH-2 two ongoing phase 3 studies and says a glycemic-control phase 3 program and cardiovascular outcomes trials are planned for the first half of 2027.

Participants / model
447 adults with type 2 diabetes and overweight or obesity
Treatment
Weekly subcutaneous enicepatide up to 24 mg
Follow-up
48 weeks
Study design
Company press release on a phase 2 trial; not peer reviewed
Funding
not stated in the source

A different trial and population from the obesity figures of 22.5% and 18.3%, and they should not be placed next to each other as the same result. The estimand and placebo adjustment of the 15.5% are not stated in the sources reviewed.

Read the original source
Registry: ENITH-1 and ENITH-2, Recruiting since March 2026, no posted results

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Record NCT07351058 (ENITH-2), with NCT07351045 (ENITH-1). Read on 10 October 2026, showing the September 2026 update.

ENITH-1 (NCT07351045, adults without type 2 diabetes, estimated 2,000, start 16 March 2026, primary endpoint percent change in body weight at week 72) and ENITH-2 (NCT07351058, with type 2 diabetes, estimated 1,600, start 23 March 2026) are both Recruiting as of the September 2026 verification, with Hoffmann-La Roche as sponsor. Neither trial has posted results. Registrations without posted results are not outcomes.

Participants / model
Adults with obesity or overweight, without and with type 2 diabetes (planned)
Treatment
Weekly subcutaneous enicepatide versus placebo, 72 weeks
Follow-up
72 weeks per participant
Study design
Registered phase 3 design and status only
Funding
Sponsor: Hoffmann-La Roche

Registry design and status only. No efficacy or safety result from either trial is public.

Read the original source
Searches, 10 October 2026: 3 PubMed records, no peer-reviewed phase 2 report

PubMed search record

PubMed search for enicepatide OR CT-388 OR CT388 OR RO7795068, run on 10 October 2026 (3 records). ClinicalTrials.gov search for the same names run the same day (8 records).

PubMed returned 3 records: the phase 1 paper (PMID 41319798), a narrative review of GLP-1 co-agonists and cardiac effects (PMID 42768195) and a 2021 review of emerging GLP-1 agonists (PMID 34176426). ClinicalTrials.gov returned 8 records (2 phase 1, 3 phase 2, 3 phase 3) with no posted results on any; the two completed phase 2 trials (NCT06525935 and NCT06628362) have none. In the records reviewed there is no peer-reviewed report of either phase 2 trial, and all phase 2 numbers are company statements.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Literature and registry searches
Funding
not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study exists.

Read the original source

Studies and sources

WHO Proposed INN List 133 (2025): dual GIP and GLP-1 receptor agonist

Chemical identity record

World Health Organization. Proposed International Nonproprietary Names: List 133. WHO Drug Information, Vol. 39, No. 2, 2025.

Enicepatide is described as a dual gastric inhibitory polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) receptor agonist, antidiabetic. The entry lists the formula C226H345FN48O67 and CAS 2869147-44-2. WHO INN entries carry no company codes. A PubChem name search for enicepatide and CT-388 returned no compound record on 10 October 2026.

Participants / model
Molecular identity, not a clinical population
Treatment
Synthetic peptide, subcutaneous
Follow-up
Not applicable
Study design
Official WHO nomenclature record (Proposed INN list)
Funding
not stated in the source

The link between the INN and the code CT-388 rests on the registry records and Roche's release, because the WHO list carries no codes.

Read the original source
Registry records: Enicepatide, RO7795068, CT-388 and RG6640 as one compound, Roche developer

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Record NCT07351045 (ENITH-1), with the phase 2 record NCT06525935. Read on 10 October 2026.

The Hoffmann-La Roche sponsored phase 3 record NCT07351045 lists the intervention Enicepatide with other names RO7795068, CT-388 and RG6640. The phase 2 record NCT06525935, sponsored by Carmot Therapeutics, lists the same names. Roche's release of 1 June 2026 writes enicepatide (CT-388). The phase 1 paper's authors are Genentech employees (previously Carmot Therapeutics), and its disclosures describe Carmot as now a member of the Roche Group.

Participants / model
Sponsor and code identity, not a clinical population
Treatment
Not applicable
Follow-up
Not applicable
Study design
Trial registry records
Funding
Sponsor of NCT07351045: Hoffmann-La Roche; sponsor of NCT06525935: Carmot Therapeutics

Enicepatide and CT-388 are treated as one compound on this page. The year of the Carmot acquisition is not stated.

Read the original source
Company release, 1 June 2026: investigational; no US application or label found

Regulatory record

Roche press release dated 1 June 2026. openFDA Drugs@FDA and DailyMed searches run on 10 October 2026.

No regulatory approval was found. On 10 October 2026 openFDA Drugs@FDA returned no application records for enicepatide and a DailyMed search returned no labels. Roche describes enicepatide as investigational in every release read. The release writes enicepatide (CT-388).

Participants / model
Not a clinical population
Treatment
Not applicable
Follow-up
Release dated 1 June 2026; searches run on 10 October 2026
Study design
Company press release and US regulator database searches
Funding
not stated in the source

A search result shows what the databases held on that date.

Read the original source
Phase 1: healthy adults with overweight or obesity, -4.7% to -8.0% at day 29 versus -0.5%

Clinical trial

Chakravarthy MV et al. Mol Metab. 2026;103:102291. PMID 41319798.

Mean percent change in body weight from baseline to day 29 was -4.7% to -8.0% across CT-388 doses versus -0.5% on placebo. CT-388 was generally well tolerated, most treatment-emergent events were mild or moderate, and the pharmacokinetics supported once-weekly dosing. The paper also reports cell, mouse and monkey work; it is authored by Genentech and former Carmot staff.

Participants / model
Otherwise healthy adults with overweight or obesity
Treatment
Subcutaneous CT-388: single doses of 0.5 to 7.5 mg or four once-weekly doses of 5 to 12 mg, or placebo
Follow-up
Single doses; four weekly doses; weight change to day 29
Study design
Randomized, double-blind, placebo-controlled phase 1 trial with preclinical data (NCT04838405)
Funding
not stated in the source

The weight figures are mean changes from baseline over four weeks and are not placebo-adjusted. The sample size and half-life are not given in the sources reviewed.

Read the original source
Company statement, 27 January 2026: phase 2, 469 adults, 22.5% and 18.3% at 24 mg, not peer reviewed

Regulatory record

Roche press release dated 27 January 2026 on the phase 2 trial CT388-103.

In the phase 2 trial CT388-103 (NCT06525935; randomized, double-blind, placebo-controlled; 469 adults with obesity, or overweight with a comorbidity, without type 2 diabetes; five dosing cohorts up to 24 mg once weekly; 48 weeks), the placebo-adjusted weight loss at 24 mg was 22.5% by the efficacy estimand and 18.3% by the treatment-regimen estimand (P<0.001). At week 48 on 24 mg, 95.7% lost at least 5%, 87% at least 10%, 47.8% at least 20% and 26.1% at least 30%. Treatment discontinuation due to adverse events was 5.9% in CT-388 arms and 1.3% on placebo. The 18.3% is a placebo-adjusted treatment-regimen figure at the 24 mg dose, not an unadjusted weight loss, and Roche's headline is the larger 22.5%.

Participants / model
469 adults with obesity or overweight, without diabetes, in the United States
Treatment
Weekly subcutaneous enicepatide (CT-388) up to 24 mg, five dosing cohorts
Follow-up
48 weeks
Study design
Company press release on a phase 2 trial; not peer reviewed
Funding
not stated in the source

Company statement dated 27 January 2026. The estimand for the weight-loss thresholds is not stated in the sources reviewed.

Read the original source
Company slides, 8 June 2026: efficacy and treatment-regimen estimands, adverse events at 24 mg

Regulatory record

Roche investor event slides dated 8 June 2026, reporting the American Diabetes Association late-breaker by Lingvay et al.

By the efficacy estimand, mean change in the 24 mg arm was -22.7% at week 48 versus -0.2% on placebo, with an estimated treatment difference of -22.5% (95% CI -25.3 to -19.8). Treatment-regimen estimand treatment differences versus placebo at week 48 were -5.0 (4 mg), -10.7 (8 mg), -11.7 (12 mg), -13.4 (16 mg) and -18.3 (24 mg; 95% CI -21.6 to -14.9). Adverse events by maximum dose reached (placebo, N=79, versus 24 mg, N=76): any adverse event 64% versus 86%, serious adverse events 0% versus 5%, nausea 19% versus 46%, diarrhea 10% versus 32% and vomiting 0% versus 21%; no fatal events and no grade 4 or 5 events.

Participants / model
Adults with obesity or overweight, without diabetes
Treatment
Weekly subcutaneous enicepatide, 4 to 24 mg
Follow-up
48 weeks
Study design
Company investor slide deck; not peer reviewed
Funding
not stated in the source

The figures were read from the slide text layer, with column alignment taken from a table extraction rather than the rendered image. The poster or abstract was not retrieved, so the safety figures should be read with caution.

Read the original source
Company statement, 22 September 2026: phase 2 in type 2 diabetes, 447 adults, not peer reviewed

Regulatory record

Roche press release dated 22 September 2026 on the phase 2 trial CT-388-104 and the enicepatide phase 3 program.

In the phase 2 trial CT-388-104 (NCT06628362; randomized, double-blind, placebo-controlled; 447 adults with type 2 diabetes and overweight or obesity; 48 weeks), HbA1c at 24 mg fell 2.65% from a baseline of 8.1%, 90% reached an HbA1c of 6.5% or lower, and mean weight loss was 15.5% at 48 weeks. Discontinuation due to adverse events was 2.0% in enicepatide arms and 0.0% on placebo. The release calls ENITH-1 and ENITH-2 two ongoing phase 3 studies and says a glycemic-control phase 3 program and cardiovascular outcomes trials are planned for the first half of 2027.

Participants / model
447 adults with type 2 diabetes and overweight or obesity
Treatment
Weekly subcutaneous enicepatide up to 24 mg
Follow-up
48 weeks
Study design
Company press release on a phase 2 trial; not peer reviewed
Funding
not stated in the source

A different trial and population from the obesity figures of 22.5% and 18.3%, and they should not be placed next to each other as the same result. The estimand and placebo adjustment of the 15.5% are not stated in the sources reviewed.

Read the original source
Registry: ENITH-1 and ENITH-2, Recruiting since March 2026, no posted results

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Record NCT07351058 (ENITH-2), with NCT07351045 (ENITH-1). Read on 10 October 2026, showing the September 2026 update.

ENITH-1 (NCT07351045, adults without type 2 diabetes, estimated 2,000, start 16 March 2026, primary endpoint percent change in body weight at week 72) and ENITH-2 (NCT07351058, with type 2 diabetes, estimated 1,600, start 23 March 2026) are both Recruiting as of the September 2026 verification, with Hoffmann-La Roche as sponsor. Neither trial has posted results. Registrations without posted results are not outcomes.

Participants / model
Adults with obesity or overweight, without and with type 2 diabetes (planned)
Treatment
Weekly subcutaneous enicepatide versus placebo, 72 weeks
Follow-up
72 weeks per participant
Study design
Registered phase 3 design and status only
Funding
Sponsor: Hoffmann-La Roche

Registry design and status only. No efficacy or safety result from either trial is public.

Read the original source
Searches, 10 October 2026: 3 PubMed records, no peer-reviewed phase 2 report

PubMed search record

PubMed search for enicepatide OR CT-388 OR CT388 OR RO7795068, run on 10 October 2026 (3 records). ClinicalTrials.gov search for the same names run the same day (8 records).

PubMed returned 3 records: the phase 1 paper (PMID 41319798), a narrative review of GLP-1 co-agonists and cardiac effects (PMID 42768195) and a 2021 review of emerging GLP-1 agonists (PMID 34176426). ClinicalTrials.gov returned 8 records (2 phase 1, 3 phase 2, 3 phase 3) with no posted results on any; the two completed phase 2 trials (NCT06525935 and NCT06628362) have none. In the records reviewed there is no peer-reviewed report of either phase 2 trial, and all phase 2 numbers are company statements.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Literature and registry searches
Funding
not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study exists.

Read the original source

Why is Enicepatide in C tier?

C fits a compound whose only peer-reviewed human data are a four-week phase 1 study. The phase 2 efficacy results in obesity and type 2 diabetes exist only as Roche press releases and an investor slide deck, and gastrointestinal events were more frequent at 24 mg. The phase 3 trials are recruiting and have no results, and no regulator has approved the compound.