NCT06703021

A Dose-Range Study of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity

A Phase 2, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Efficacy of Increasing Optimal 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 (ACCESS II)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (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

Phase 2 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of various aleniglipron (GSBR-1290) dose regimens compared with placebo in participants living with obesity or overweight with ≥ 1 weight-related comorbidity, in addition to diet and exercise, over a 44-week period.

Conditions

• Obesity
• Overweight
• 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 or placebo	Drug: aleniglipron administered orally; Drug: placebo administered orally

Timeline

• Start date: 2024-12-20
• Primary completion: 2025-11-01
• Completion: 2025-12-01
• First posted: 2024-11-25
• Last updated: 2025-09-15

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study