A Randomized, Double-Blind, Placebo-Controlled, Pivotal Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of Multiple Maintenance Doses of Once Daily Oral Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and a Weight-Related Comorbidity

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

Summary

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.

Eligibility

Age range: 18–79 years
Sex: All
Healthy volunteers

A Randomized, Double-Blind, Placebo-Controlled, Pivotal Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of Multiple Maintenance Doses of Once Daily Oral Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and a Weight-Related Comorbidity

Summary

Eligibility

Interventions

Locations (71)