Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)

Condition(s) studied

Investigational drug(s) / intervention(s)

Aleniglipron: Drug: aleniglipron administered orally Drug

Placebo: Drug: placebo administered orally

Study 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

Primary outcome measure(s)

• Percent change in body weight from Baseline — Baseline and Week 76

Trial sites (71)

+ 31 more sites — see the full list on the official registry below.

More Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics trials in the USA

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