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-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.

NCT Number	NCT07654361
Lead Sponsor	Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Conditions	Obesity, Overweight, Chronic Weight Management
Enrollment	3,600 participants
Start Date	2026-07-13
Primary Completion	2028-09 (estimated)
Study Completion	2028-11 (estimated)
Updated on ClinicalTrials.gov	2026-08-10