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.
Signed informed consent
BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities.
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.
Parallel
Aleniglipron
DrugDrug: aleniglipron administered orally Drug
Placebo
DrugDrug: placebo administered orally
Percent change in body weight from Baseline
Change in body weight (absolute) from Baseline
Percentage of participants who achieve ≥5% reduction in body weight
Percentage of participants who achieve ≥10% reduction in body weight
Percentage of participants who achieve ≥15% reduction in body weight
Percentage of participants who achieve ≥25% reduction in body weight
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