A Dose-Range Study of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity
Purpose
Phase 2 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of various aleniglipron (GSBR-1290) dose regimens compared with placebo in participants living with obesity or overweight with ≥ 1 weight-related comorbidity, in addition to diet and exercise, over a 44-week period.
Conditions
- Obesity
- Overweight
- Chronic Weight Management
Eligibility
- Eligible Ages
- Between 18 Years and 79 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 - Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening) - Use of medications intended to promote weight loss, within 6 months prior to Screening
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Sentinel |
Participants will receive aleniglipron or placebo administered orally. |
|
|
Experimental Cohort 1a |
Participants will receive aleniglipron or placebo administered orally. |
|
|
Experimental Cohort 1b |
Participants will receive aleniglipron or placebo administered orally. |
|
|
Experimental Cohort 1c |
Participants will receive aleniglipron or placebo administered orally. |
|
Recruiting Locations
More Details
- NCT ID
- NCT06703021
- Status
- Active, not recruiting
- Sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics