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
- Interventions
- Registration Number
- NCT06693843
- Lead Sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 220
- Signed informed consent
- BMI ≥30 kg/m2 or BMI ≥27.0 kg/m2 and previous/current diagnosis of ≥ 1 obesity related comorbidity
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 GSBR-1290 or Placebo Participants will receive GSBR-1290 or Placebo administered orally. Cohort 2 GSBR-1290 or Placebo Participants will receive GSBR-1290 or Placebo administered orally. Cohort 3 GSBR-1290 or Placebo Participants will receive GSBR-1290 or Placebo administered orally. Cohort 1 Aleniglipron or Placebo Participants will receive Aleniglipron or Placebo administered orally. Cohort 2 Aleniglipron or Placebo Participants will receive Aleniglipron or Placebo administered orally. Cohort 3 Aleniglipron or Placebo Participants will receive Aleniglipron or Placebo administered orally. Cohort 1 OLE Aleniglipron Participants will receive Aleniglipron administered orally Cohort 2 OLE Aleniglipron Participants will receive Aleniglipron administered orally Cohort 3 OLE Aleniglipron Participants will receive Aleniglipron administered orally Cohort 4 OLE Aleniglipron Participants will receive Aleniglipron administered orally
- Primary Outcome Measures
Name Time Method Percent change in body weight from Baseline to Week 36 Baseline and week 36
- Secondary Outcome Measures
Name Time Method Percentage of participants who achieve ≥5% reduction in body weight at Week 36 Baseline and week 36 Percentage of participants who achieve ≥10% reduction in body weight at Week 36 Baseline and week 36 Percentage of participants who achieve ≥15% reduction in body weight at Week 36 Baseline and week 36 Change in body weight (absolute) from Baseline to Week 36 Baseline and week 36 Change in waist circumference from Baseline to Week 36 Baseline and week 36 Change in body mass index from Baseline to Week 36 Baseline and week 36
Trial Locations
- Locations (1)
ACCESS Research Site
🇺🇸Morgantown, West Virginia, United States
ACCESS Research Site🇺🇸Morgantown, West Virginia, United States