NCT06693843

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

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2) or Overweight (Body Mass Index ≥ 27 kg/m2) With at Least One Weight-related Comorbidity

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Obesity, Overweight, or Chronic Weight Management

Interventions

Type	Name	Description
DRUG	Aleniglipron or Placebo	Drug: Aleniglipron Administered orally Drug: Placebo Administered orally
DRUG	Aleniglipron or Placebo	Drug: Aleniglipron Administered orally Drug: Placebo Administered orally
DRUG	Aleniglipron or Placebo	Drug: Aleniglipron Administered orally Drug: Placebo Administered orally
DRUG	Aleniglipron	Drug: Aleniglipron Administered orally
DRUG	Aleniglipron	Drug: Aleniglipron Administered orally
DRUG	Aleniglipron	Drug: Aleniglipron Administered orally
DRUG	Aleniglipron	Drug: Aleniglipron Administered orally

Timeline

• Start date: 2024-10-17
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2024-11-18
• Last updated: 2025-12-29

Locations

39 sites across 1 country: United States

Regulatory

• FDA-regulated drug study