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NCT07654361 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)
A Phase 3 study, sponsored by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics.
- Not yet
- Registry status
- Phase 3
- Development phase
- 3,600
- Enrollment target
NCT07654361: Clinical Trial Phase 3 study, sponsored by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics.
NCT07654361 is a Phase 3 study that has not yet begun recruiting, run by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics. The registered enrollment target is 3,600 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (366% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07654361, a Phase 3 study, has not yet begun recruiting, sponsored by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 3,600 participants
- Enrollment target
Study Summary
Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie diet and increased physical activity. All participants will be randomized to at least 76 weeks of treatment to evaluate the effects on long term body weight changes, tolerability, and safety. In addition, the study will compare the effects between aleniglipron and placebo on blood pressure (BP), lipid parameters, patient-reported outcomes.
Interventions
- DRUG Placebo
- DRUG Aleniglipron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,600 participants |
| Start Date | 2026-07 |
| Est. Completion | 2028-11 |
| Phase | Phase 3 |
What is known before NCT07654361 opens enrollment
NCT07654361 is an interventional study that assigns participants to a tested intervention. Its 3,600 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (366% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07654361 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07654361 about?
NCT07654361 is a clinical study titled "Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)". Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calor...
What is the current status of trial NCT07654361?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 3,600 participants. The study started on 2026-07. Estimated completion is 2028-11.
What interventions are being tested in trial NCT07654361?
The interventions under investigation include: Placebo (DRUG), Aleniglipron (DRUG).
Who is sponsoring clinical trial NCT07654361?
This trial is sponsored by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07654361's enrollment target sits among peer trials
3,600 68th of 2000 higher than 1,933 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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