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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

Purpose

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.

Condition

Obesity, Overweight, or 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 - 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

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 Cohort 1	Participants will receive Aleniglipron or Placebo administered orally.	Drug: Aleniglipron or Placebo Drug: Aleniglipron Administered orally Drug: Placebo Administered orally Drug: Aleniglipron Drug: Aleniglipron Administered orally
Experimental Cohort 2	Participants will receive Aleniglipron or Placebo administered orally.	Drug: Aleniglipron or Placebo Drug: Aleniglipron Administered orally Drug: Placebo Administered orally Drug: Aleniglipron Drug: Aleniglipron Administered orally
Experimental Cohort 3	Participants will receive Aleniglipron or Placebo administered orally.	Drug: Aleniglipron or Placebo Drug: Aleniglipron Administered orally Drug: Placebo Administered orally Drug: Aleniglipron Drug: Aleniglipron Administered orally
Active Comparator Cohort 1 OLE	Participants will receive Aleniglipron administered orally	Drug: Aleniglipron Drug: Aleniglipron Administered orally
Active Comparator Cohort 2 OLE	Participants will receive Aleniglipron administered orally	Drug: Aleniglipron Drug: Aleniglipron Administered orally
Active Comparator Cohort 3 OLE	Participants will receive Aleniglipron administered orally	Drug: Aleniglipron Drug: Aleniglipron Administered orally
Active Comparator Cohort 4 OLE	Participants will receive Aleniglipron administered orally	Drug: Aleniglipron Drug: Aleniglipron Administered orally

Recruiting Locations

More Details

NCT ID: NCT06693843
Status: Active, not recruiting
Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.