A Phase 2, Randomized, Double-blind, Placebo-controlled, Study Evaluating the Effects of Aleniglipron (GSBR-1290) on Body Composition in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2)
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a randomized, double-blind, placebo-controlled study evaluating the effects of aleniglipron on body composition in participants living with obesity. Participants will be randomized to aleniglipron or placebo in a ratio of 5:1. Participants will receive multiple ascending QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 40 weeks of treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:
• Signed informed consent
• Participants age ≥18 years and \<80 years, with BMI ≥30 kg/m2
• Screening HbA1c \<6.5 %
Locations
United States
Arizona
Research Site
RECRUITING
Phoenix
Illinois
Research Site
RECRUITING
Chicago
Minnesota
Research Site
RECRUITING
Richfield
Missouri
Research Site
RECRUITING
City Of Saint Peters
North Carolina
Research Site
RECRUITING
Wilmington
New York
Research Site
RECRUITING
Rochester
Oklahoma
Research Site
RECRUITING
Norman
South Carolina
Research Site
RECRUITING
Moncks Corner
Research Site
RECRUITING
North Charleston
Texas
Research Site
RECRUITING
Austin
Research Site
RECRUITING
San Antonio
Contact Information
Primary
Medical Director
GSBRClinicalTrials@structuretx.com
1-650-457-1959
Time Frame
Start Date: 2025-08-15
Estimated Completion Date: 2026-10
Participants
Target number of participants: 66
Treatments
Experimental: Cohort 1
Participants will receive aleniglipron or placebo administered orally.
Experimental: Cohort 2
Participants will receive aleniglipron or placebo administered orally.
Related Therapeutic Areas
Sponsors
Leads: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics