Elecoglipron

updated

Elecoglipron (AZD5004, ECC5004) is an unapproved oral small-molecule GLP-1 receptor agonist developed by AstraZeneca under a 2023 license from Eccogene. In the peer-reviewed phase 2 trial VISTA (310 adults with obesity or overweight and no diabetes), the estimated mean change in bodyweight at week 26 ranged from -2.6% at 5 mg to -10.5% at 75 mg with weekly titration, versus -0.6% on placebo, and these figures are not placebo-adjusted. Nine phase 3 studies are registered and recruiting, with no results.

Oral small-molecule GLP-1 receptor agonist

  • Elecoglipron is PubChem CID 169644648, C48H46F2N10O5, 880.9 g/mol, CAS 3011682-49-5, with AZD5004 and ECC-5004 among its synonyms. A separate ECC5004 PubChem record differs at one stereocenter, so PubChem alone does not settle that the two are the same stereoisomer.
  • In VISTA (310 adults, no diabetes, week 26) the estimated mean change in bodyweight ranged from -2.6% (5 mg) to -10.5% (75 mg with weekly titration) versus -0.6% on placebo, not placebo-adjusted. Adverse events were reported by 84% to 98% on elecoglipron versus 84% on placebo.
  • In SOLSTICE (406 randomized adults with type 2 diabetes, week 26), HbA1c changed from -0.91% (5 mg) to -1.88% (75 mg with 2-weekly escalation) versus -0.15% on placebo.
  • ClinicalTrials.gov listed 9 phase 3 studies on 10 October 2026, all recruiting and all sponsored by AstraZeneca, with start dates from 29 June to 24 August 2026 and no results.
  • An openFDA Drugs@FDA search and a DailyMed search on 10 October 2026 found no FDA application record and no label. No pharmacokinetic values were found in a source reviewed.

What is elecoglipron, and is it approved anywhere?

Elecoglipron (AZD5004, ECC5004) is an oral small-molecule GLP-1 receptor agonist developed by AstraZeneca under a 2023 license from Eccogene. It is not approved: no FDA application record or label turned up on 10 October 2026, and no approval appears in any source reviewed.

Elecoglipron is PubChem CID 169644648, C48H46F2N10O5, 880.9 g/mol, CAS 3011682-49-5. It is listed as an INN and USAN, with AZD5004, AZD-5004 and ECC-5004 among the synonyms. A separate PubChem record titled ECC5004 (CID 167350327, CAS 3011682-51-9) has the same formula and weight but differs in the stereo descriptor of the dimethyloxanyl group, (4R) there and (4S) in the elecoglipron record. The vendor-listed ECC5004 record may therefore be the other epimer or a separate drawing, and PubChem alone does not settle whether they are the same stereoisomer. The peer-reviewed first-in-human report names the molecule ECC5004/AZD5004 with AstraZeneca authors. The registry sponsor is Eccogene for the early ECC5004 studies and AstraZeneca for the AZD5004 and elecoglipron studies.

In a statement dated 9 November 2023, AstraZeneca announced an exclusive license for ECC5004 from Eccogene, giving AstraZeneca global rights for any indication in all territories except China, where Eccogene has the right to co-develop and co-commercialise. The release states an initial upfront payment of $185m and up to an additional $1.825bn in milestones, plus tiered royalties. It is an archived company statement that uses only the name ECC5004 and carries a notice that it is not a source for current efficacy or safety data.

On 10 October 2026 an openFDA Drugs@FDA search by generic name returned no application records, and a DailyMed search returned 0 labels. No approval appears in any source reviewed.

PubChem: elecoglipron identity and codes, with a separate ECC5004 record

Chemical identity record

National Library of Medicine. PubChem compound record CID 169644648 (elecoglipron).

Elecoglipron is PubChem CID 169644648, C48H46F2N10O5, 880.9 g/mol, CAS 3011682-49-5, listed as an INN and USAN, with AZD5004, AZD-5004 and ECC-5004 among the synonyms. A separate PubChem record titled ECC5004 (CID 167350327, CAS 3011682-51-9, same formula and weight) differs in the stereo descriptor of the dimethyloxanyl group ((4R) there, (4S) in the elecoglipron record), so the vendor-listed ECC5004 record may be the other epimer or a separate drawing. PubChem alone does not settle whether they are the same stereoisomer. The peer-reviewed first-in-human report names the molecule ECC5004/AZD5004 with AstraZeneca authors, and the registry sponsor is Eccogene for the early ECC5004 studies (for example NCT05654831) and AstraZeneca for AZD5004 and elecoglipron studies.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined molecule, oral tablet
Follow-up
Not applicable
Study design
NLM chemical records, with registry sponsor information
Funding
not stated in the source

The two PubChem records differ at one stereocenter, so a vial sold as ECC5004 cannot be tied to elecoglipron by the code alone.

Read the original source
Company statement, 9 November 2023: AstraZeneca license from Eccogene, archived

Regulatory record

AstraZeneca press release, 9 November 2023, on astrazeneca.com (archived).

AstraZeneca announced an exclusive license for ECC5004 from Eccogene, giving AstraZeneca global rights for any indication in all territories except China, where Eccogene has the right to co-develop and co-commercialise alongside AstraZeneca. The release states an initial upfront payment of $185m and up to an additional $1.825bn in clinical, regulatory and commercial milestones, plus tiered royalties. It calls ECC5004 a once-daily, low-dose small-molecule GLP-1RA in a US phase 1 trial, uses only the name ECC5004, and carries an archive notice saying it is not a source for current efficacy or safety data.

Participants / model
Not a clinical population
Treatment
License agreement
Follow-up
Statement dated 9 November 2023
Study design
Company press release on a license agreement; not peer reviewed
Funding
not stated in the source

The license figures are company statements from an archived release.

Read the original source
First-in-human report: receptor pharmacology, primates, phase 1 in healthy volunteers and type 2 diabetes

Human study

Haggag AZ et al. Diabetes Obes Metab. 2025;27(2):551-562. PMID 39495140.

ECC5004 bound the human GLP-1 receptor (IC50 = 2.4 nM) and augmented cAMP signalling without beta-arrestin-2 recruitment or receptor internalization, and potentiated glucose-stimulated insulin secretion in a human beta-cell line and in non-human primates. A 9-month non-human primate toxicity study showed dose-dependent body weight changes. In the phase I double-blind placebo-controlled study, single doses of 1 to 300 mg in healthy volunteers and multiple daily doses of 5, 10, 30 and 50 mg for 28 days in patients with type 2 diabetes were well tolerated with no serious adverse events, and showed dose-dependent glucose and body weight reductions with dose-proportional exposure at doses of at least 25 mg. The abstract gives no pharmacokinetic numbers beyond saying the profile is compatible with once-daily oral dosing.

Participants / model
Cell lines, non-human primates, healthy volunteers, and patients with type 2 diabetes
Treatment
ECC5004 oral tablets
Follow-up
Single doses; 28 days of multiple daily doses; 9-month primate toxicity study
Study design
Original preclinical and phase 1 study (NCT05654831); the phase 1 was double-blind and placebo-controlled
Funding
not stated in the source

The abstract gives no primate dose or route and no pharmacokinetic values, so no animal row is listed under dosing literature.

Read the original source
US searches, 10 October 2026: no application records and no labels

Regulatory record

DailyMed, U.S. National Library of Medicine, search for elecoglipron; openFDA Drugs@FDA search by generic name. Both run on 10 October 2026.

An openFDA Drugs@FDA search by generic name elecoglipron returned no application records, and a DailyMed search for elecoglipron returned 0 labels. No FDA approval or label exists in those sources.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Dated regulatory search
Funding
not stated in the source

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

Read the original source

What did the phase 2 study in obesity find?

In VISTA, the estimated mean change in bodyweight at week 26 ranged from -2.6% at 5 mg to -10.5% at 75 mg with weekly titration, versus -0.6% on placebo, in 310 adults with obesity or overweight and no diabetes. These changes are not placebo-adjusted.

VISTA (NCT06579092) was a double-blind randomized phase 2 dose-ranging study funded by AstraZeneca and published in the Lancet. It randomized 310 adults with obesity (BMI 30 or above) or overweight (BMI 27 or above) plus a weight-related condition, without diabetes, 2:3:3:3:3:5 to once-daily oral elecoglipron in five arms (5 mg, 15 mg, 50 mg, and 75 mg on two escalation schedules) or placebo for 36 weeks. Mean age was 48.4 years, 73% were female, and mean baseline weight was 106.9 kg.

The dual primary endpoints were measured at week 26. The estimated mean change in bodyweight ranged from -2.6% (5 mg) to -10.5% (75 mg with weekly titration) versus -0.6% on placebo. The estimated proportion with at least 5% weight loss was 40.4 to 88.8% versus 15.6%. These are estimated changes in bodyweight and are not placebo-adjusted. The 36-week weight figures and the placebo-adjusted values were not in the abstract.

VISTA phase 2: 310 adults without diabetes, week 26 weight change up to -10.5%

Randomized controlled trial

Davies MJ et al. Lancet. 2026;407(10547):2503-2514. PMID 42259337.

At week 26 the estimated mean change in bodyweight ranged from -2.6% (5 mg) to -10.5% (75 mg with weekly titration) versus -0.6% on placebo, and the estimated proportion with at least 5% weight loss was 40.4 to 88.8% versus 15.6%. Adverse events were reported by 84% (27 of 32) to 98% (48 of 49) of participants on elecoglipron versus 84% (68 of 81) on placebo, most commonly nausea, constipation, diarrhoea, headache and vomiting. 288 (93%) completed the study and 231 (75%) completed assigned treatment.

Participants / model
310 adults with obesity (BMI 30 or above) or overweight (BMI 27 or above) plus a weight-related condition, without diabetes (mean age 48.4 years, 73% female, mean baseline weight 106.9 kg)
Treatment
Elecoglipron oral tablets once daily, 5 to 75 mg, in five arms (5 mg, 15 mg, 50 mg, and 75 mg on two escalation schedules), or placebo
Follow-up
36 weeks; dual primary endpoints at week 26
Study design
Double-blind randomized phase 2 dose-ranging study (NCT06579092), randomized 2:3:3:3:3:5
Funding
Funded by AstraZeneca

The week 26 changes are estimated mean changes in bodyweight and are not placebo-adjusted. The 36-week weight figures and placebo-adjusted values were not in the abstract.

Read the original source

What did the phase 2b study in type 2 diabetes find?

In SOLSTICE (406 randomized adults with type 2 diabetes), HbA1c at week 26 changed from -0.91% at 5 mg to -1.88% at 75 mg with 2-weekly escalation, versus -0.15% on placebo. The abstract gives no result for the oral semaglutide comparator arm.

SOLSTICE (NCT06579105) was a phase 2b randomized double-blind placebo-controlled trial across nine countries. It randomized 406 adults with type 2 diabetes (HbA1c 7.0 to 10.5%, or 6.5 to 10.5% in the USA) on diet and exercise or metformin or an SGLT2 inhibitor to elecoglipron at 5, 15 or 25 mg, or to arms escalated to 50 and 75 mg, to placebo, or to open-label oral semaglutide 14 mg, for 26 weeks. 404 adults were dosed. Mean baseline HbA1c was 7.9% and mean weight 99.8 kg.

At week 26, HbA1c changed from -0.91% (5 mg) to -1.88% (75 mg with 2-weekly escalation) versus -0.15% on placebo. The abstract reports no semaglutide comparator result, so no comparison with semaglutide is made here.

SOLSTICE phase 2b: 406 randomized adults with type 2 diabetes, HbA1c at week 26

Randomized controlled trial

Aroda VR et al. Lancet. 2026;407(10547):2515-2527. PMID 42259343.

At week 26, HbA1c changed from -0.91% (5 mg) to -1.88% (75 mg with 2-weekly escalation) versus -0.15% on placebo. Adverse events were reported by 63% to 87% on elecoglipron versus 63% (45 of 71) on placebo, mostly gastrointestinal. The abstract reports no semaglutide comparator result.

Participants / model
404 dosed adults with type 2 diabetes (406 randomized; HbA1c 7.0 to 10.5%, or 6.5 to 10.5% in the USA; mean baseline HbA1c 7.9% and weight 99.8 kg), across nine countries, on diet and exercise or metformin or an SGLT2 inhibitor
Treatment
Elecoglipron oral tablets once daily, 5, 15 or 25 mg or 50 and 75 mg arms, versus placebo or open-label oral semaglutide 14 mg
Follow-up
26 weeks
Study design
Randomized double-blind placebo-controlled phase 2b trial with an open-label oral semaglutide arm (NCT06579105)
Funding
not stated in the source

The semaglutide comparator results were not in the abstract.

Read the original source

What did the first-in-human study find?

In a phase I double-blind placebo-controlled study, single doses of 1 to 300 mg in healthy volunteers and 28 days of daily doses in patients with type 2 diabetes were well tolerated with no serious adverse events. Glucose and body weight fell dose-dependently, with dose-proportional exposure at doses of at least 25 mg.

The first-in-human report (NCT05654831) combined cell and primate pharmacology with a phase I double-blind placebo-controlled study. Single doses of 1 to 300 mg were given to healthy volunteers, and multiple daily doses of 5, 10, 30 and 50 mg for 28 days to patients with type 2 diabetes. The doses were well tolerated with no serious adverse events and showed dose-dependent glucose and body weight reductions, with dose-proportional exposure at doses of at least 25 mg.

The abstract gives no pharmacokinetic numbers beyond saying the profile is compatible with once-daily oral dosing. A 9-month non-human primate toxicity study showed dose-dependent body weight changes, and the abstract gives no primate dose or route.

First-in-human report: receptor pharmacology, primates, phase 1 in healthy volunteers and type 2 diabetes

Human study

Haggag AZ et al. Diabetes Obes Metab. 2025;27(2):551-562. PMID 39495140.

ECC5004 bound the human GLP-1 receptor (IC50 = 2.4 nM) and augmented cAMP signalling without beta-arrestin-2 recruitment or receptor internalization, and potentiated glucose-stimulated insulin secretion in a human beta-cell line and in non-human primates. A 9-month non-human primate toxicity study showed dose-dependent body weight changes. In the phase I double-blind placebo-controlled study, single doses of 1 to 300 mg in healthy volunteers and multiple daily doses of 5, 10, 30 and 50 mg for 28 days in patients with type 2 diabetes were well tolerated with no serious adverse events, and showed dose-dependent glucose and body weight reductions with dose-proportional exposure at doses of at least 25 mg. The abstract gives no pharmacokinetic numbers beyond saying the profile is compatible with once-daily oral dosing.

Participants / model
Cell lines, non-human primates, healthy volunteers, and patients with type 2 diabetes
Treatment
ECC5004 oral tablets
Follow-up
Single doses; 28 days of multiple daily doses; 9-month primate toxicity study
Study design
Original preclinical and phase 1 study (NCT05654831); the phase 1 was double-blind and placebo-controlled
Funding
not stated in the source

The abstract gives no primate dose or route and no pharmacokinetic values, so no animal row is listed under dosing literature.

Read the original source

Which phase 3 studies are registered, and do they have results?

ClinicalTrials.gov listed 9 phase 3 studies on 10 October 2026, all recruiting and all sponsored by AstraZeneca, with start dates from 29 June to 24 August 2026. They include two large outcomes studies. None has results.

The ClinicalTrials.gov query elecoglipron returned 11 records on 10 October 2026: 9 phase 3 studies, all recruiting, and 2 phase 1 studies. All nine phase 3 studies list AstraZeneca as sponsor, with registry start dates from 29 June to 24 August 2026.

They include the obesity master protocol EMBOLD (NCT07667803, estimated 4500 participants, start 29 June 2026, primary outcome percent body weight loss at 72 weeks), EMBOLD-Asia (NCT07775404, 351 participants, start 21 August 2026, week 52), the heart-failure outcomes study Elevate-HF (NCT07761117, 6950 participants, start 24 August 2026), the kidney outcomes study Elevate-CKD (NCT07753993, 7000 participants, start 21 August 2026), and five type 2 diabetes studies, one of them against oral semaglutide. These are registrations, and no phase 3 results exist.

The query AZD5004 returned 14 records, including 11 completed phase 1 studies (renal impairment, hepatic impairment, mass balance and absolute bioavailability, formulation and drug interaction) and two completed ECC5004 studies, none with posted results. A completed registration with no posted results is not an outcome.

Registry, 10 October 2026: 9 phase 3 studies, all recruiting, no results

Trial registry record

ClinicalTrials.gov query elecoglipron and record NCT07667803 (EMBOLD), read on 10 October 2026.

ClinicalTrials.gov returned 11 records for the query elecoglipron on 10 October 2026: 9 phase 3 studies, all Recruiting, and 2 phase 1 studies. All nine phase 3 studies list AstraZeneca as sponsor, with registry start dates from 2026-06-29 to 2026-08-24. They include the obesity master protocol EMBOLD (NCT07667803, estimated n=4500, start 2026-06-29, primary outcome percent body weight loss at 72 weeks), EMBOLD-Asia (NCT07775404, n=351, start 2026-08-21, week 52), the heart-failure outcomes study Elevate-HF (NCT07761117, n=6950, start 2026-08-24), the kidney outcomes study Elevate-CKD (NCT07753993, n=7000, start 2026-08-21), and five type 2 diabetes studies (NCT07662044, NCT07662109, NCT07662135, NCT07662213 versus oral semaglutide, NCT07664553). These are registrations; no phase 3 results exist.

Participants / model
Registered participants, not a clinical population
Treatment
Elecoglipron film-coated tablet once daily
Follow-up
Registry start dates from 29 June to 24 August 2026
Study design
Trial registry record; no posted results
Funding
not stated in the source

A registration describes a plan, not a result. Sample sizes are estimates.

Read the original source
Searches, 10 October 2026: 3 papers, 14 AZD5004 records, no pharmacokinetic values

PubMed search record

PubMed search for elecoglipron OR AZD5004 OR ECC5004 and ClinicalTrials.gov queries for AZD5004, run on 10 October 2026.

The ClinicalTrials.gov query AZD5004 returned 14 records (11 phase 1, 2 phase 2, 1 phase 3). All 11 phase 1 records are Completed and none has posted results, including renal impairment (NCT06742762), hepatic impairment (NCT06813781), mass balance and absolute bioavailability (NCT06857695), and formulation and drug-interaction studies (for example NCT06948747 and NCT06942936). The ECC5004-titled studies NCT06268145 and NCT06293742 are also completed without posted results. A PubMed search for elecoglipron OR AZD5004 OR ECC5004 returned 3 records, the first-in-human paper and the two Lancet phase 2 reports. No pharmacokinetic values for elecoglipron were found in a source reviewed.

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

A search result shows what the databases held on that date. A completed registration with no posted results has no reportable result here.

Read the original source

Is elecoglipron licensed by AstraZeneca from Eccogene, with a phase 3 program starting?

The license is supported by a 2023 company statement, and the phase 3 claim is correct and understated: the registry already lists 9 recruiting phase 3 studies from AstraZeneca. No phase 3 results exist.

Sellers describe elecoglipron as an oral small-molecule GLP-1 agonist licensed by AstraZeneca from Eccogene, with a phase 3 program starting.

The license is described in AstraZeneca's archived statement of 9 November 2023, which gives AstraZeneca global rights except China, where Eccogene may co-develop and co-commercialise. The phase 3 part is understated. By 10 October 2026 the registry showed nine phase 3 studies, all recruiting, with start dates between 29 June and 24 August 2026. They are registrations, and the peer-reviewed weight and HbA1c data are phase 2 only.

Company statement, 9 November 2023: AstraZeneca license from Eccogene, archived

Regulatory record

AstraZeneca press release, 9 November 2023, on astrazeneca.com (archived).

AstraZeneca announced an exclusive license for ECC5004 from Eccogene, giving AstraZeneca global rights for any indication in all territories except China, where Eccogene has the right to co-develop and co-commercialise alongside AstraZeneca. The release states an initial upfront payment of $185m and up to an additional $1.825bn in clinical, regulatory and commercial milestones, plus tiered royalties. It calls ECC5004 a once-daily, low-dose small-molecule GLP-1RA in a US phase 1 trial, uses only the name ECC5004, and carries an archive notice saying it is not a source for current efficacy or safety data.

Participants / model
Not a clinical population
Treatment
License agreement
Follow-up
Statement dated 9 November 2023
Study design
Company press release on a license agreement; not peer reviewed
Funding
not stated in the source

The license figures are company statements from an archived release.

Read the original source
Registry, 10 October 2026: 9 phase 3 studies, all recruiting, no results

Trial registry record

ClinicalTrials.gov query elecoglipron and record NCT07667803 (EMBOLD), read on 10 October 2026.

ClinicalTrials.gov returned 11 records for the query elecoglipron on 10 October 2026: 9 phase 3 studies, all Recruiting, and 2 phase 1 studies. All nine phase 3 studies list AstraZeneca as sponsor, with registry start dates from 2026-06-29 to 2026-08-24. They include the obesity master protocol EMBOLD (NCT07667803, estimated n=4500, start 2026-06-29, primary outcome percent body weight loss at 72 weeks), EMBOLD-Asia (NCT07775404, n=351, start 2026-08-21, week 52), the heart-failure outcomes study Elevate-HF (NCT07761117, n=6950, start 2026-08-24), the kidney outcomes study Elevate-CKD (NCT07753993, n=7000, start 2026-08-21), and five type 2 diabetes studies (NCT07662044, NCT07662109, NCT07662135, NCT07662213 versus oral semaglutide, NCT07664553). These are registrations; no phase 3 results exist.

Participants / model
Registered participants, not a clinical population
Treatment
Elecoglipron film-coated tablet once daily
Follow-up
Registry start dates from 29 June to 24 August 2026
Study design
Trial registry record; no posted results
Funding
not stated in the source

A registration describes a plan, not a result. Sample sizes are estimates.

Read the original source

How does elecoglipron work, and what is known about its exposure?

ECC5004 bound the human GLP-1 receptor and drove cAMP signaling without beta-arrestin-2 recruitment or receptor internalization in cells. No pharmacokinetic values were found in a source reviewed, beyond a statement of dose-proportional exposure at doses of at least 25 mg.

In the first-in-human report, ECC5004 bound the human GLP-1 receptor (IC50 = 2.4 nM) and augmented cAMP signalling without beta-arrestin-2 recruitment or receptor internalization. It potentiated glucose-stimulated insulin secretion in a human beta-cell line and in non-human primates. These are cell and primate findings.

In people, the phase I study showed dose-dependent glucose and body weight reductions with dose-proportional exposure at doses of at least 25 mg. No pharmacokinetic values for elecoglipron were found in a source reviewed, so half-life and Tmax are not established. The 11 completed phase 1 AZD5004 registrations, including renal impairment, hepatic impairment and mass balance studies, have no posted results.

First-in-human report: receptor pharmacology, primates, phase 1 in healthy volunteers and type 2 diabetes

Human study

Haggag AZ et al. Diabetes Obes Metab. 2025;27(2):551-562. PMID 39495140.

ECC5004 bound the human GLP-1 receptor (IC50 = 2.4 nM) and augmented cAMP signalling without beta-arrestin-2 recruitment or receptor internalization, and potentiated glucose-stimulated insulin secretion in a human beta-cell line and in non-human primates. A 9-month non-human primate toxicity study showed dose-dependent body weight changes. In the phase I double-blind placebo-controlled study, single doses of 1 to 300 mg in healthy volunteers and multiple daily doses of 5, 10, 30 and 50 mg for 28 days in patients with type 2 diabetes were well tolerated with no serious adverse events, and showed dose-dependent glucose and body weight reductions with dose-proportional exposure at doses of at least 25 mg. The abstract gives no pharmacokinetic numbers beyond saying the profile is compatible with once-daily oral dosing.

Participants / model
Cell lines, non-human primates, healthy volunteers, and patients with type 2 diabetes
Treatment
ECC5004 oral tablets
Follow-up
Single doses; 28 days of multiple daily doses; 9-month primate toxicity study
Study design
Original preclinical and phase 1 study (NCT05654831); the phase 1 was double-blind and placebo-controlled
Funding
not stated in the source

The abstract gives no primate dose or route and no pharmacokinetic values, so no animal row is listed under dosing literature.

Read the original source
Searches, 10 October 2026: 3 papers, 14 AZD5004 records, no pharmacokinetic values

PubMed search record

PubMed search for elecoglipron OR AZD5004 OR ECC5004 and ClinicalTrials.gov queries for AZD5004, run on 10 October 2026.

The ClinicalTrials.gov query AZD5004 returned 14 records (11 phase 1, 2 phase 2, 1 phase 3). All 11 phase 1 records are Completed and none has posted results, including renal impairment (NCT06742762), hepatic impairment (NCT06813781), mass balance and absolute bioavailability (NCT06857695), and formulation and drug-interaction studies (for example NCT06948747 and NCT06942936). The ECC5004-titled studies NCT06268145 and NCT06293742 are also completed without posted results. A PubMed search for elecoglipron OR AZD5004 OR ECC5004 returned 3 records, the first-in-human paper and the two Lancet phase 2 reports. No pharmacokinetic values for elecoglipron were found in a source reviewed.

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

A search result shows what the databases held on that date. A completed registration with no posted results has no reportable result here.

Read the original source

What adverse effects have been reported?

Adverse events were reported by 84% to 98% of participants on elecoglipron in VISTA versus 84% on placebo, most commonly nausea, constipation, diarrhoea, headache and vomiting. In VISTA 75% completed assigned treatment. No liver-safety statement or pharmacokinetic data were found in a source reviewed.

In VISTA (310 adults, 36 weeks), adverse events were reported by 84% (27 of 32) to 98% (48 of 49) of participants on elecoglipron versus 84% (68 of 81) on placebo, most commonly nausea, constipation, diarrhoea, headache and vomiting. 288 (93%) completed the study and 231 (75%) completed assigned treatment.

In SOLSTICE (404 dosed adults with type 2 diabetes, 26 weeks), adverse events were reported by 63% to 87% on elecoglipron versus 63% (45 of 71) on placebo, mostly gastrointestinal. The first-in-human study reported no serious adverse events at single doses of 1 to 300 mg and 28 days of daily doses.

No liver-safety statement, pharmacokinetic values or phase 3 safety data were found in a source reviewed.

VISTA phase 2: 310 adults without diabetes, week 26 weight change up to -10.5%

Randomized controlled trial

Davies MJ et al. Lancet. 2026;407(10547):2503-2514. PMID 42259337.

At week 26 the estimated mean change in bodyweight ranged from -2.6% (5 mg) to -10.5% (75 mg with weekly titration) versus -0.6% on placebo, and the estimated proportion with at least 5% weight loss was 40.4 to 88.8% versus 15.6%. Adverse events were reported by 84% (27 of 32) to 98% (48 of 49) of participants on elecoglipron versus 84% (68 of 81) on placebo, most commonly nausea, constipation, diarrhoea, headache and vomiting. 288 (93%) completed the study and 231 (75%) completed assigned treatment.

Participants / model
310 adults with obesity (BMI 30 or above) or overweight (BMI 27 or above) plus a weight-related condition, without diabetes (mean age 48.4 years, 73% female, mean baseline weight 106.9 kg)
Treatment
Elecoglipron oral tablets once daily, 5 to 75 mg, in five arms (5 mg, 15 mg, 50 mg, and 75 mg on two escalation schedules), or placebo
Follow-up
36 weeks; dual primary endpoints at week 26
Study design
Double-blind randomized phase 2 dose-ranging study (NCT06579092), randomized 2:3:3:3:3:5
Funding
Funded by AstraZeneca

The week 26 changes are estimated mean changes in bodyweight and are not placebo-adjusted. The 36-week weight figures and placebo-adjusted values were not in the abstract.

Read the original source
SOLSTICE phase 2b: 406 randomized adults with type 2 diabetes, HbA1c at week 26

Randomized controlled trial

Aroda VR et al. Lancet. 2026;407(10547):2515-2527. PMID 42259343.

At week 26, HbA1c changed from -0.91% (5 mg) to -1.88% (75 mg with 2-weekly escalation) versus -0.15% on placebo. Adverse events were reported by 63% to 87% on elecoglipron versus 63% (45 of 71) on placebo, mostly gastrointestinal. The abstract reports no semaglutide comparator result.

Participants / model
404 dosed adults with type 2 diabetes (406 randomized; HbA1c 7.0 to 10.5%, or 6.5 to 10.5% in the USA; mean baseline HbA1c 7.9% and weight 99.8 kg), across nine countries, on diet and exercise or metformin or an SGLT2 inhibitor
Treatment
Elecoglipron oral tablets once daily, 5, 15 or 25 mg or 50 and 75 mg arms, versus placebo or open-label oral semaglutide 14 mg
Follow-up
26 weeks
Study design
Randomized double-blind placebo-controlled phase 2b trial with an open-label oral semaglutide arm (NCT06579105)
Funding
not stated in the source

The semaglutide comparator results were not in the abstract.

Read the original source
First-in-human report: receptor pharmacology, primates, phase 1 in healthy volunteers and type 2 diabetes

Human study

Haggag AZ et al. Diabetes Obes Metab. 2025;27(2):551-562. PMID 39495140.

ECC5004 bound the human GLP-1 receptor (IC50 = 2.4 nM) and augmented cAMP signalling without beta-arrestin-2 recruitment or receptor internalization, and potentiated glucose-stimulated insulin secretion in a human beta-cell line and in non-human primates. A 9-month non-human primate toxicity study showed dose-dependent body weight changes. In the phase I double-blind placebo-controlled study, single doses of 1 to 300 mg in healthy volunteers and multiple daily doses of 5, 10, 30 and 50 mg for 28 days in patients with type 2 diabetes were well tolerated with no serious adverse events, and showed dose-dependent glucose and body weight reductions with dose-proportional exposure at doses of at least 25 mg. The abstract gives no pharmacokinetic numbers beyond saying the profile is compatible with once-daily oral dosing.

Participants / model
Cell lines, non-human primates, healthy volunteers, and patients with type 2 diabetes
Treatment
ECC5004 oral tablets
Follow-up
Single doses; 28 days of multiple daily doses; 9-month primate toxicity study
Study design
Original preclinical and phase 1 study (NCT05654831); the phase 1 was double-blind and placebo-controlled
Funding
not stated in the source

The abstract gives no primate dose or route and no pharmacokinetic values, so no animal row is listed under dosing literature.

Read the original source

Why does elecoglipron sit in B tier?

B reflects two peer-reviewed phase 2 trials in the Lancet, a published first-in-human study and nine registered phase 3 studies. It is not higher because the weight data so far are moderate and not placebo-adjusted, with adverse events in up to 98% of participants on active drug in VISTA, and there are no phase 3 data and no approval.

B fits a compound with phase 2 results in the Lancet (310 adults with obesity, 406 with type 2 diabetes), a published first-in-human study, and nine registered phase 3 studies that began between June and August 2026, including two large outcomes studies.

The weight data so far are moderate: -10.5% at 26 weeks in the top arm of VISTA versus -0.6% on placebo, estimated and not placebo-adjusted, with adverse events in up to 98% of participants on active drug in that trial. The site grades the approved oral small molecule orforglipron at S. Elecoglipron has no phase 3 data and no approval.

VISTA phase 2: 310 adults without diabetes, week 26 weight change up to -10.5%

Randomized controlled trial

Davies MJ et al. Lancet. 2026;407(10547):2503-2514. PMID 42259337.

At week 26 the estimated mean change in bodyweight ranged from -2.6% (5 mg) to -10.5% (75 mg with weekly titration) versus -0.6% on placebo, and the estimated proportion with at least 5% weight loss was 40.4 to 88.8% versus 15.6%. Adverse events were reported by 84% (27 of 32) to 98% (48 of 49) of participants on elecoglipron versus 84% (68 of 81) on placebo, most commonly nausea, constipation, diarrhoea, headache and vomiting. 288 (93%) completed the study and 231 (75%) completed assigned treatment.

Participants / model
310 adults with obesity (BMI 30 or above) or overweight (BMI 27 or above) plus a weight-related condition, without diabetes (mean age 48.4 years, 73% female, mean baseline weight 106.9 kg)
Treatment
Elecoglipron oral tablets once daily, 5 to 75 mg, in five arms (5 mg, 15 mg, 50 mg, and 75 mg on two escalation schedules), or placebo
Follow-up
36 weeks; dual primary endpoints at week 26
Study design
Double-blind randomized phase 2 dose-ranging study (NCT06579092), randomized 2:3:3:3:3:5
Funding
Funded by AstraZeneca

The week 26 changes are estimated mean changes in bodyweight and are not placebo-adjusted. The 36-week weight figures and placebo-adjusted values were not in the abstract.

Read the original source
SOLSTICE phase 2b: 406 randomized adults with type 2 diabetes, HbA1c at week 26

Randomized controlled trial

Aroda VR et al. Lancet. 2026;407(10547):2515-2527. PMID 42259343.

At week 26, HbA1c changed from -0.91% (5 mg) to -1.88% (75 mg with 2-weekly escalation) versus -0.15% on placebo. Adverse events were reported by 63% to 87% on elecoglipron versus 63% (45 of 71) on placebo, mostly gastrointestinal. The abstract reports no semaglutide comparator result.

Participants / model
404 dosed adults with type 2 diabetes (406 randomized; HbA1c 7.0 to 10.5%, or 6.5 to 10.5% in the USA; mean baseline HbA1c 7.9% and weight 99.8 kg), across nine countries, on diet and exercise or metformin or an SGLT2 inhibitor
Treatment
Elecoglipron oral tablets once daily, 5, 15 or 25 mg or 50 and 75 mg arms, versus placebo or open-label oral semaglutide 14 mg
Follow-up
26 weeks
Study design
Randomized double-blind placebo-controlled phase 2b trial with an open-label oral semaglutide arm (NCT06579105)
Funding
not stated in the source

The semaglutide comparator results were not in the abstract.

Read the original source
First-in-human report: receptor pharmacology, primates, phase 1 in healthy volunteers and type 2 diabetes

Human study

Haggag AZ et al. Diabetes Obes Metab. 2025;27(2):551-562. PMID 39495140.

ECC5004 bound the human GLP-1 receptor (IC50 = 2.4 nM) and augmented cAMP signalling without beta-arrestin-2 recruitment or receptor internalization, and potentiated glucose-stimulated insulin secretion in a human beta-cell line and in non-human primates. A 9-month non-human primate toxicity study showed dose-dependent body weight changes. In the phase I double-blind placebo-controlled study, single doses of 1 to 300 mg in healthy volunteers and multiple daily doses of 5, 10, 30 and 50 mg for 28 days in patients with type 2 diabetes were well tolerated with no serious adverse events, and showed dose-dependent glucose and body weight reductions with dose-proportional exposure at doses of at least 25 mg. The abstract gives no pharmacokinetic numbers beyond saying the profile is compatible with once-daily oral dosing.

Participants / model
Cell lines, non-human primates, healthy volunteers, and patients with type 2 diabetes
Treatment
ECC5004 oral tablets
Follow-up
Single doses; 28 days of multiple daily doses; 9-month primate toxicity study
Study design
Original preclinical and phase 1 study (NCT05654831); the phase 1 was double-blind and placebo-controlled
Funding
not stated in the source

The abstract gives no primate dose or route and no pharmacokinetic values, so no animal row is listed under dosing literature.

Read the original source
Registry, 10 October 2026: 9 phase 3 studies, all recruiting, no results

Trial registry record

ClinicalTrials.gov query elecoglipron and record NCT07667803 (EMBOLD), read on 10 October 2026.

ClinicalTrials.gov returned 11 records for the query elecoglipron on 10 October 2026: 9 phase 3 studies, all Recruiting, and 2 phase 1 studies. All nine phase 3 studies list AstraZeneca as sponsor, with registry start dates from 2026-06-29 to 2026-08-24. They include the obesity master protocol EMBOLD (NCT07667803, estimated n=4500, start 2026-06-29, primary outcome percent body weight loss at 72 weeks), EMBOLD-Asia (NCT07775404, n=351, start 2026-08-21, week 52), the heart-failure outcomes study Elevate-HF (NCT07761117, n=6950, start 2026-08-24), the kidney outcomes study Elevate-CKD (NCT07753993, n=7000, start 2026-08-21), and five type 2 diabetes studies (NCT07662044, NCT07662109, NCT07662135, NCT07662213 versus oral semaglutide, NCT07664553). These are registrations; no phase 3 results exist.

Participants / model
Registered participants, not a clinical population
Treatment
Elecoglipron film-coated tablet once daily
Follow-up
Registry start dates from 29 June to 24 August 2026
Study design
Trial registry record; no posted results
Funding
not stated in the source

A registration describes a plan, not a result. Sample sizes are estimates.

Read the original source
US searches, 10 October 2026: no application records and no labels

Regulatory record

DailyMed, U.S. National Library of Medicine, search for elecoglipron; openFDA Drugs@FDA search by generic name. Both run on 10 October 2026.

An openFDA Drugs@FDA search by generic name elecoglipron returned no application records, and a DailyMed search for elecoglipron returned 0 labels. No FDA approval or label exists in those sources.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Dated regulatory search
Funding
not stated in the source

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

Read the original source

Studies and sources

PubChem: elecoglipron identity and codes, with a separate ECC5004 record

Chemical identity record

National Library of Medicine. PubChem compound record CID 169644648 (elecoglipron).

Elecoglipron is PubChem CID 169644648, C48H46F2N10O5, 880.9 g/mol, CAS 3011682-49-5, listed as an INN and USAN, with AZD5004, AZD-5004 and ECC-5004 among the synonyms. A separate PubChem record titled ECC5004 (CID 167350327, CAS 3011682-51-9, same formula and weight) differs in the stereo descriptor of the dimethyloxanyl group ((4R) there, (4S) in the elecoglipron record), so the vendor-listed ECC5004 record may be the other epimer or a separate drawing. PubChem alone does not settle whether they are the same stereoisomer. The peer-reviewed first-in-human report names the molecule ECC5004/AZD5004 with AstraZeneca authors, and the registry sponsor is Eccogene for the early ECC5004 studies (for example NCT05654831) and AstraZeneca for AZD5004 and elecoglipron studies.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined molecule, oral tablet
Follow-up
Not applicable
Study design
NLM chemical records, with registry sponsor information
Funding
not stated in the source

The two PubChem records differ at one stereocenter, so a vial sold as ECC5004 cannot be tied to elecoglipron by the code alone.

Read the original source
Company statement, 9 November 2023: AstraZeneca license from Eccogene, archived

Regulatory record

AstraZeneca press release, 9 November 2023, on astrazeneca.com (archived).

AstraZeneca announced an exclusive license for ECC5004 from Eccogene, giving AstraZeneca global rights for any indication in all territories except China, where Eccogene has the right to co-develop and co-commercialise alongside AstraZeneca. The release states an initial upfront payment of $185m and up to an additional $1.825bn in clinical, regulatory and commercial milestones, plus tiered royalties. It calls ECC5004 a once-daily, low-dose small-molecule GLP-1RA in a US phase 1 trial, uses only the name ECC5004, and carries an archive notice saying it is not a source for current efficacy or safety data.

Participants / model
Not a clinical population
Treatment
License agreement
Follow-up
Statement dated 9 November 2023
Study design
Company press release on a license agreement; not peer reviewed
Funding
not stated in the source

The license figures are company statements from an archived release.

Read the original source
First-in-human report: receptor pharmacology, primates, phase 1 in healthy volunteers and type 2 diabetes

Human study

Haggag AZ et al. Diabetes Obes Metab. 2025;27(2):551-562. PMID 39495140.

ECC5004 bound the human GLP-1 receptor (IC50 = 2.4 nM) and augmented cAMP signalling without beta-arrestin-2 recruitment or receptor internalization, and potentiated glucose-stimulated insulin secretion in a human beta-cell line and in non-human primates. A 9-month non-human primate toxicity study showed dose-dependent body weight changes. In the phase I double-blind placebo-controlled study, single doses of 1 to 300 mg in healthy volunteers and multiple daily doses of 5, 10, 30 and 50 mg for 28 days in patients with type 2 diabetes were well tolerated with no serious adverse events, and showed dose-dependent glucose and body weight reductions with dose-proportional exposure at doses of at least 25 mg. The abstract gives no pharmacokinetic numbers beyond saying the profile is compatible with once-daily oral dosing.

Participants / model
Cell lines, non-human primates, healthy volunteers, and patients with type 2 diabetes
Treatment
ECC5004 oral tablets
Follow-up
Single doses; 28 days of multiple daily doses; 9-month primate toxicity study
Study design
Original preclinical and phase 1 study (NCT05654831); the phase 1 was double-blind and placebo-controlled
Funding
not stated in the source

The abstract gives no primate dose or route and no pharmacokinetic values, so no animal row is listed under dosing literature.

Read the original source
VISTA phase 2: 310 adults without diabetes, week 26 weight change up to -10.5%

Randomized controlled trial

Davies MJ et al. Lancet. 2026;407(10547):2503-2514. PMID 42259337.

At week 26 the estimated mean change in bodyweight ranged from -2.6% (5 mg) to -10.5% (75 mg with weekly titration) versus -0.6% on placebo, and the estimated proportion with at least 5% weight loss was 40.4 to 88.8% versus 15.6%. Adverse events were reported by 84% (27 of 32) to 98% (48 of 49) of participants on elecoglipron versus 84% (68 of 81) on placebo, most commonly nausea, constipation, diarrhoea, headache and vomiting. 288 (93%) completed the study and 231 (75%) completed assigned treatment.

Participants / model
310 adults with obesity (BMI 30 or above) or overweight (BMI 27 or above) plus a weight-related condition, without diabetes (mean age 48.4 years, 73% female, mean baseline weight 106.9 kg)
Treatment
Elecoglipron oral tablets once daily, 5 to 75 mg, in five arms (5 mg, 15 mg, 50 mg, and 75 mg on two escalation schedules), or placebo
Follow-up
36 weeks; dual primary endpoints at week 26
Study design
Double-blind randomized phase 2 dose-ranging study (NCT06579092), randomized 2:3:3:3:3:5
Funding
Funded by AstraZeneca

The week 26 changes are estimated mean changes in bodyweight and are not placebo-adjusted. The 36-week weight figures and placebo-adjusted values were not in the abstract.

Read the original source
SOLSTICE phase 2b: 406 randomized adults with type 2 diabetes, HbA1c at week 26

Randomized controlled trial

Aroda VR et al. Lancet. 2026;407(10547):2515-2527. PMID 42259343.

At week 26, HbA1c changed from -0.91% (5 mg) to -1.88% (75 mg with 2-weekly escalation) versus -0.15% on placebo. Adverse events were reported by 63% to 87% on elecoglipron versus 63% (45 of 71) on placebo, mostly gastrointestinal. The abstract reports no semaglutide comparator result.

Participants / model
404 dosed adults with type 2 diabetes (406 randomized; HbA1c 7.0 to 10.5%, or 6.5 to 10.5% in the USA; mean baseline HbA1c 7.9% and weight 99.8 kg), across nine countries, on diet and exercise or metformin or an SGLT2 inhibitor
Treatment
Elecoglipron oral tablets once daily, 5, 15 or 25 mg or 50 and 75 mg arms, versus placebo or open-label oral semaglutide 14 mg
Follow-up
26 weeks
Study design
Randomized double-blind placebo-controlled phase 2b trial with an open-label oral semaglutide arm (NCT06579105)
Funding
not stated in the source

The semaglutide comparator results were not in the abstract.

Read the original source
Registry, 10 October 2026: 9 phase 3 studies, all recruiting, no results

Trial registry record

ClinicalTrials.gov query elecoglipron and record NCT07667803 (EMBOLD), read on 10 October 2026.

ClinicalTrials.gov returned 11 records for the query elecoglipron on 10 October 2026: 9 phase 3 studies, all Recruiting, and 2 phase 1 studies. All nine phase 3 studies list AstraZeneca as sponsor, with registry start dates from 2026-06-29 to 2026-08-24. They include the obesity master protocol EMBOLD (NCT07667803, estimated n=4500, start 2026-06-29, primary outcome percent body weight loss at 72 weeks), EMBOLD-Asia (NCT07775404, n=351, start 2026-08-21, week 52), the heart-failure outcomes study Elevate-HF (NCT07761117, n=6950, start 2026-08-24), the kidney outcomes study Elevate-CKD (NCT07753993, n=7000, start 2026-08-21), and five type 2 diabetes studies (NCT07662044, NCT07662109, NCT07662135, NCT07662213 versus oral semaglutide, NCT07664553). These are registrations; no phase 3 results exist.

Participants / model
Registered participants, not a clinical population
Treatment
Elecoglipron film-coated tablet once daily
Follow-up
Registry start dates from 29 June to 24 August 2026
Study design
Trial registry record; no posted results
Funding
not stated in the source

A registration describes a plan, not a result. Sample sizes are estimates.

Read the original source
US searches, 10 October 2026: no application records and no labels

Regulatory record

DailyMed, U.S. National Library of Medicine, search for elecoglipron; openFDA Drugs@FDA search by generic name. Both run on 10 October 2026.

An openFDA Drugs@FDA search by generic name elecoglipron returned no application records, and a DailyMed search for elecoglipron returned 0 labels. No FDA approval or label exists in those sources.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Dated regulatory search
Funding
not stated in the source

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

Read the original source

Why is Elecoglipron in B tier?

B fits a compound with two peer-reviewed phase 2 trials in the Lancet, a published first-in-human study and nine registered phase 3 studies. It is not higher because the weight data so far are moderate and not placebo-adjusted, adverse events reached up to 98% of participants on active drug in VISTA, and there are no phase 3 data and no approval.