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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
Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2024-10-17
Completion Date
2026-08
Last Updated
2025-12-29
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
Drug: Aleniglipron Administered orally
Aleniglipron
Drug: Aleniglipron Administered orally
Aleniglipron
Drug: Aleniglipron Administered orally
Aleniglipron
Drug: Aleniglipron Administered orally
Locations (39)
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Phoenix, Arizona, United States
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Anaheim, California, United States
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Los Angeles, California, United States
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Montclair, California, United States
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Rancho Cucamonga, California, United States
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Sacramento, California, United States
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Spring Valley, California, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Muncie, Indiana, United States
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Valparaiso, Indiana, United States
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West Des Moines, Iowa, United States
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Baton Rouge, Louisiana, United States
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Richfield, Minnesota, United States
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City of Saint Peters, Missouri, United States
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Hazelwood, Missouri, United States
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Springfield, Missouri, United States
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Albany, New York, United States
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Binghamton, New York, United States
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Brooklyn, New York, United States
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Rochester, New York, United States
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Wilmington, North Carolina, United States
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Cincinnati, Ohio, United States
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Norman, Oklahoma, United States
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Medford, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Moncks Corner, South Carolina, United States
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Chattanooga, Tennessee, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Mesquite, Texas, United States
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Shavano Park, Texas, United States
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West Jordan, Utah, United States
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Winchester, Virginia, United States
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Morgantown, West Virginia, United States