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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

NCT06693843

CompletedPhase 2

Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Conditions: Obesity, Overweight, or Chronic Weight Management

Interventions: Aleniglipron or Placebo, Aleniglipron or Placebo, Aleniglipron or Placebo, Aleniglipron, Aleniglipron

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 79 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Signed informed consent
* BMI ≥30 kg/m2 or BMI ≥27.0 kg/m2 and previous/current diagnosis of ≥ 1 obesity related comorbidity

Exclusion Criteria:

* Previous documented diagnosis of diabetes mellitus.
* Self-reported change in body weight \>5% within 3 months before Screening
* Body weight ≤80 kg at Screening
* Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed \>1 year prior to screening)

Locations (39)

Phoenix, Arizona, United States
Anaheim, California, United States
Los Angeles, California, United States
Montclair, California, United States
Rancho Cucamonga, California, United States
Sacramento, California, United States
Spring Valley, California, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Evanston, Illinois, United States
Muncie, Indiana, United States
Valparaiso, Indiana, United States
West Des Moines, Iowa, United States
Baton Rouge, Louisiana, United States
Richfield, Minnesota, United States
City of Saint Peters, Missouri, United States
Hazelwood, Missouri, United States
Springfield, Missouri, United States
Albany, New York, United States
Binghamton, New York, United States
Brooklyn, New York, United States
Rochester, New York, United States
Wilmington, North Carolina, United States
Cincinnati, Ohio, United States
Norman, Oklahoma, United States
Medford, Oregon, United States
Pittsburgh, Pennsylvania, United States
Moncks Corner, South Carolina, United States
Chattanooga, Tennessee, United States
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