Pipeline › aleniglipron
aleniglipron
Not FDA-approved, and in phase 2 development, not authorised in the European Union. 4 active trials, the next due to complete 2028-09.
incretin (auto-detected) agonist, unknown, from Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics. Every figure below is taken directly from ClinicalTrials.gov, Drugs@FDA, the FDA Drug Shortage Database, the EMA register or Europe PMC, and re-checked every four hours.
- Status
- phase2
- Target
- incretin (auto-detected)
- Route
- unknown
- Sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
- First FDA approval
- Not approved
- EU authorisation
- Not authorised
- Active trials
- 4 (2 in phase 3)
- Participants enrolled
- 4,829
- Trials with a reporting date
- 2
- Approved FDA submissions
- 0
Recent changes
| Detected | Change | Trial | Detail | Phase |
|---|---|---|---|---|
| 2026-08-21 | New trial registered | A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2) NCT07654374 · Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics | Recruiting, n=1,100 | P3 |
| 2026-08-21 | New trial registered | Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1) NCT07654361 · Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics | Recruiting, n=3,600 | P3 |
| 2026-08-21 | New trial registered | Aleniglipron Phase 2 in Type 2 Diabetes Mellitus NCT07400588 · Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics | Active, not recruiting, n=58 | P2 |
| 2026-08-21 | New trial registered | Aleniglipron Phase 2 Body Composition Study NCT07169942 · Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics | Active, not recruiting, n=71 | P2 |
| 2026-08-21 | New trial registered | A Phase 2b, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity NCT06693843 · Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics | Completed, n=230 | P2 |
| 2026-08-21 | New trial registered | A Dose-Range Study of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity NCT06703021 · Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics | Completed, n=85 | P2 |
When these trials report
Next 2 of 2 active trials by estimated primary completion.
| Est. completion | Trial | Sponsor | Phase | Participants |
|---|---|---|---|---|
| 2028-09 | A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2) NCT07654374 · Percent change in body weight from Baseline | Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics | P3 | 1,100 |
| 2028-09 | Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1) NCT07654361 · Percent change in body weight from Baseline | Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics | P3 | 3,600 |
Indications under study
Chronic Weight Management; Obese; Obesity; Obesity Type 2 Diabetes Mellitus; Obesity, Overweight, or Chronic Weight Management; Overweight; Type2 Diabetes Mellitus; Weight Loss.
Recent papers
| Published | Title | Journal |
|---|---|---|
| 2026-08-01 | Publisher Correction: Oral small molecule GLP-1 receptor agonist aleniglipron in people with overweight or obesity: a randomized, double-blind, placebo-controlled phase 2b trial Rosenstock J, Lingvay I, Ryan D, Jastreboff AM, Kushner R, Acosta A, Blevins TC, Choi M, Holmes FL, Smith T, Connery L, Li Y, Liu MK, Barth A, Butcher J, Civitarese A, Yue H, Coll B, ACCESS Trial Investigators. | Nat Med |
| 2026-06-05 | Oral small molecule GLP-1 receptor agonist aleniglipron in people with overweight or obesity: a randomized, double-blind, placebo-controlled phase 2b trial Rosenstock J, Lingvay I, Ryan D, Jastreboff AM, Kushner R, Acosta A, Blevins TC, Choi M, Holmes FL, Smith T, Connery L, Li Y, Liu MK, Barth A, Butcher J, Civitarese A, Yue H, Coll B, ACCESS Trial Investigators. | Nat Med |