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

Phase 2

Active, not recruiting

• Conditions: Obesity, Overweight, or Chronic Weight Management
• Interventions: Drug: GSBR-1290 or Placebo

• 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-17
• Study First Submitted: 2024-11-15
• Study First Submitted QC: 2024-11-15
• Study First Posted: 2024-11-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-10
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 220

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

• 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.

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