Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07654361
The ClinicalTrials.gov registry entry for NCT07654361 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 3,600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07654361 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.