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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)
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.
Age
18 - 79 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
December 20, 2024
Primary Completion Date
November 1, 2025
Completion Date
December 1, 2025
Last Updated
September 15, 2025
82
ESTIMATED participants
aleniglipron or placebo
DRUG
aleniglipron or placebo
DRUG
aleniglipron or placebo
DRUG
aleniglipron or placebo
DRUG
Lead Sponsor
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
NCT07472881
NCT01143454
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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