A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2) or Overweight (Body Mass Index ≥ 27 kg/m2) With at Least One Weight-related Comorbidity
Overview
- Phase
- Phase 2
- Intervention
- Aleniglipron or Placebo
- Conditions
- Obesity, Overweight, or Chronic Weight Management
- Sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
- Enrollment
- 220
- Locations
- 40
- Primary Endpoint
- Percent change in body weight from Baseline to Week 36
- Status
- Active, not recruiting
- Last Updated
- 4 days ago
Overview
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.
Investigators
Eligibility Criteria
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)
Arms & Interventions
Cohort 1
Participants will receive Aleniglipron or Placebo administered orally.
Intervention: Aleniglipron or Placebo
Cohort 2
Participants will receive Aleniglipron or Placebo administered orally.
Intervention: Aleniglipron or Placebo
Cohort 3
Participants will receive Aleniglipron or Placebo administered orally.
Intervention: Aleniglipron or Placebo
Cohort 1 OLE
Participants will receive Aleniglipron administered orally
Intervention: Aleniglipron
Cohort 2 OLE
Participants will receive Aleniglipron administered orally
Intervention: Aleniglipron
Cohort 3 OLE
Participants will receive Aleniglipron administered orally
Intervention: Aleniglipron
Cohort 4 OLE
Participants will receive Aleniglipron administered orally
Intervention: Aleniglipron
Outcomes
Primary Outcomes
Percent change in body weight from Baseline to Week 36
Time Frame: Baseline and week 36
Double Blind Period
Evaluate the safety and tolerability of participants with abnormal vital signs, including blood pressure, heart rate, and temperature
Time Frame: Baseline and week 72
Open -Label Extension
Percent change in body weight from Baseline to Week 36
Time Frame: Baseline and week 36
Double Blind Period
TEAEs and SAEs
Time Frame: Baseline and week 72
Open -Label Extension
Evaluate long-term safety and tolerability of aleniglipron as measured through electrocardiograms (including, but not limited to, the measurements of ventricular HR, PR interval, QRS duration, QT interval, and QTcF)
Time Frame: Baseline and week 72
Open -Label Extension
AESI
Time Frame: Baseline and week 72
Open -Label Extension
Evaluate the safety and tolerability of participants with abnormal laboratory values, including hematology, serum chemistry, and coagulation
Time Frame: Baseline and week 72
Open -Label Extension
Secondary Outcomes
- 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)
- Percentage of participants who achieve ≥15% 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 mass index from Baseline to Week 36(Baseline and week 36)
- Percentage of participants who achieve ≥10% reduction in body weight(Baseline to week 72 & Week 36-72)
- Percentage of participants who achieve ≥5% 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)
- Percent change in body weight(Baseline to week 72 & Week 36-72)
- Percentage of participants who achieve ≥5% reduction in body weight(Baseline to week 72 & Week 36-72)
- Percentage of participants who achieve ≥10% reduction in body weight at Week 36(Baseline and week 36)
- Change in body weight(Baseline to week 72 & Week 36-72)
- Change in body mass(Baseline to week 72 & Week 36-72)
- Change in waist circumference(Baseline to week 72 & Week 36-72)
- Percentage of participants who achieve ≥15% reduction in body weight(Baseline to week 72 & Week 36-72)