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A Dose-Range Study of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity
Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
82
Start Date
2024-12-20
Completion Date
2025-12
Last Updated
2025-09-15
Healthy Volunteers
No
Interventions
aleniglipron or placebo
Drug: aleniglipron administered orally; Drug: placebo administered orally
aleniglipron or placebo
Drug: aleniglipron administered orally; Drug: placebo administered orally
aleniglipron or placebo
Drug: aleniglipron administered orally; Drug: placebo administered orally
aleniglipron or placebo
Drug: aleniglipron administered orally; Drug: placebo administered orally
Locations (10)
ACCESS II Research Site
Glendale, California, United States
ACCESS II Research Site
Montclair, California, United States
ACCESS II Research Site
Valparaiso, Indiana, United States
ACCESS II Research Site
West Des Moines, Iowa, United States
ACCESS II Research Site
Medford, Oregon, United States
ACCESS II Research Site
East Greenwich, Rhode Island, United States
ACCESS II Research Site
North Charleston, South Carolina, United States
ACCESS II Research Site
Dallas, Texas, United States
ACCESS II Research Site
San Antonio, Texas, United States
ACCESS II Research Site
West Jordan, Utah, United States