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

This study is a randomized, double-blind, placebo-controlled, dose-range finding study of the efficacy, safety, tolerability, PK, and PD of multiple doses of aleniglipron in participants living with overweight or obesity with at least one weight-related comorbidity. Participants will be randomized to aleniglipron or placebo in a ratio of 3:1 within each Cohort receiving multiple-ascending, QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 36 weeks of treatment. At the end of the study (after completing 36 weeks of treatment), participants will be offered to continue with an open-label extension (OLE) where they will receive aleniglipron for an additional 36 weeks.

NCT Number	NCT06693843
Lead Sponsor	Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Conditions	Obesity, Overweight, or Chronic Weight Management
Enrollment	230 participants
Start Date	2024-10-28
Primary Completion	2025-10-24 (estimated)
Study Completion	2026-07-09 (estimated)
Updated on ClinicalTrials.gov	2026-08-10