A Phase 2b, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of 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 GSBR-1290 in participants living with overweight or obesity with at least one weight-related comorbidity. Participants will be randomized to GSBR-1290 or placebo in a ratio of 3:1 within each Cohort receiving multiple-ascending, QD doses of GSBR-1290 or placebo in titration steps of 4 weeks duration for a total of 36 weeks of treatment.

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

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 		Participants will receive GSBR-1290 or Placebo administered orally.
  • Drug: GSBR-1290 or Placebo
    Drug: GSBR-1290 Administered orally Drug: Placebo Administered orally
Experimental
Cohort 2 		Participants will receive GSBR-1290 or Placebo administered orally.
  • Drug: GSBR-1290 or Placebo
    Drug: GSBR-1290 Administered orally Drug: Placebo Administered orally
Experimental
Cohort 3 		Participants will receive GSBR-1290 or Placebo administered orally.
  • Drug: GSBR-1290 or Placebo
    Drug: GSBR-1290 Administered orally Drug: Placebo Administered orally

Recruiting Locations

More Details

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

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center