Active — Not RecruitingPhase 2

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

United States220 participantsStarted 2024-10-28

Plain-language 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.

Who can participate

Age range

18 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent change in body weight from Baseline to Week 36

Timeframe: Baseline and week 36

TEAEs and SAEs

Timeframe: Baseline and week 72

AESI

Timeframe: Baseline and week 72

Evaluate the safety and tolerability of participants with abnormal laboratory values, including hematology, serum chemistry, and coagulation

Timeframe: Baseline and week 72

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)

Timeframe: Baseline and week 72

Evaluate the safety and tolerability of participants with abnormal vital signs, including blood pressure, heart rate, and temperature

Timeframe: Baseline and week 72

Trial details

NCT IDNCT06693843

SponsorGasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-24

View on ClinicalTrials.gov More Obesity, Overweight, or Chronic Weight Management trials

Plain-language summary

Who can participate

Age range

18 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percent change in body weight from Baseline to Week 36

Timeframe: Baseline and week 36

TEAEs and SAEs

Timeframe: Baseline and week 72

AESI

Timeframe: Baseline and week 72

Evaluate the safety and tolerability of participants with abnormal laboratory values, including hematology, serum chemistry, and coagulation

Timeframe: Baseline and week 72

Evaluate the safety and tolerability of participants with abnormal vital signs, including blood pressure, heart rate, and temperature

Timeframe: Baseline and week 72