No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 79
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
3,600 (estimated)
Sponsor
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics · Industry
Who this trial is looking for
This trial is looking for adults with obesity or overweight who have health problems related to their weight. Participants will take a daily medication called aleniglipron for at least 76 weeks while following a reduced-calorie diet and increasing physical activity.
Are You a Good Fit for This Trial?
You may be able to join if
I have signed the informed consent.
I have a BMI of 30 or higher, or a BMI of 27 or higher with related health issues.
You may not be able to join if
I have been diagnosed with type 1 diabetes or type 2 diabetes.
I have lost more than 5 kg in the last 3 months.
I have had or plan to have surgery or other treatments for obesity.
I have obesity caused by other hormonal problems.
I have poor kidney function.
I have chronic malabsorption issues.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie diet and increased physical activity. All participants will be randomized to at least 76 weeks of…
Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie diet and increased physical activity. All participants will be randomized to at least 76 weeks of treatment to evaluate the effects on long term body weight changes, tolerability, and safety. In addition, the study will compare the effects between aleniglipron and placebo on blood pressure (BP), lipid parameters, patient-reported outcomes.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Signed informed consent
* BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities.
Exclusion Criteria:
* Previously documented diagnosis of type 1 diabetes, type 2 diabetes, or any other type of diabetes.
* Self-reported ch…
Inclusion Criteria:
* Signed informed consent
* BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities.
Exclusion Criteria:
* Previously documented diagnosis of type 1 diabetes, type 2 diabetes, or any other type of diabetes.
* Self-reported change in body weight \>5 kg within 3 months before Screening.
* Have prior or planned surgical or non-surgical treatment for obesity.
* Have or plan to have endoscopic and/or device-based therapy for obesity.
* Have obesity induced by other endocrine disorders.
* Impaired renal function at Screening
* Chronic malabsorption
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