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Completed
NCT06693843
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
Conditions: Obesity, Overweight, or Chronic Weight Management
Sex: All
Ages: 18 Years – 79 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 230
Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Location: ACCESS Research Site Phoenix Arizona
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.
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)
Source: ClinicalTrials.gov (NCT06693843). StuddyBuddy aggregates publicly available trial information.