NCT07169942

Aleniglipron Phase 2 Body Composition Study

A Phase 2, Randomized, Double-blind, Placebo-controlled, Study Evaluating the Effects of Aleniglipron (GSBR-1290) on Body Composition in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• 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 is a randomized, double-blind, placebo-controlled study evaluating the effects of aleniglipron on body composition in participants living with obesity. Participants will be randomized to aleniglipron or placebo in a ratio of 5:1. Participants will receive multiple ascending QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 40 weeks of treatment.

Conditions

• Obesity, Overweight, or Chronic Weight Management

Interventions

Type	Name	Description
DRUG	aleniglipron or placebo	Drug: aleniglipron administered orally Drug: placebo administered orally

Timeline

• Start date: 2025-08-15
• Primary completion: 2026-08-01
• Completion: 2026-10-01
• First posted: 2025-09-12
• Last updated: 2026-03-03

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study