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

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Obesity, Overweight, Chronic Weight Management

In brief

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.

Key facts

Study ID

NCT07654361

Run by

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

People needed

3600

Starts

2026-07-01

Expected to finish

2028-11-01

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent
• BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities.

You may not qualify if…

• 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

Where it is running

• ACCOMPLISH-1 Research Site — Birmingham, Alabama, United States
• ACCOMPLISH-1 Research Site — Phoenix, Arizona, United States
• ACCOMPLISH-1 Research Site — Sun City West, Arizona, United States
• ACCOMPLISH-1 Research Site — Tucson, Arizona, United States
• ACCOMPLISH-1 Research Site — Escondido, California, United States
• ACCOMPLISH-1 Research Site — Gardena, California, United States
• ACCOMPLISH-1 Research Site — La Jolla, California, United States
• ACCOMPLISH-1 Research Site — Modesto, California, United States
• ACCOMPLISH-1 Research Site — Rolling Hills Estates, California, United States
• ACCOMPLISH-1 Research Site — San Diego, California, United States
• ACCOMPLISH-1 Research Site — Clearwater, Florida, United States
• ACCOMPLISH-1 Research Site — Leesburg, Florida, United States
• ACCOMPLISH-1 Research Site — Miami, Florida, United States
• ACCOMPLISH-1 Research Site — Ocala, Florida, United States
• ACCOMPLISH-1 Research Site — Ocoee, Florida, United States
• ACCOMPLISH-1 Research Site — Pembroke, Florida, United States
• ACCOMPLISH-1 Research Site — Tampa, Florida, United States
• ACCOMPLISH-1 Research Site — Buford, Georgia, United States
• ACCOMPLISH-1 Research Site — Columbus, Georgia, United States
• ACCOMPLISH-1 Research Site — Lawrenceville, Georgia, United States
• ACCOMPLISH-1 Research Site — Union City, Georgia, United States
• ACCOMPLISH-1 Research Site — Woodstock, Georgia, United States
• ACCOMPLISH-1 Research Site — Honolulu, Hawaii, United States
• ACCOMPLISH-1 Research Site — Meridian, Idaho, United States
• ACCOMPLISH-1 Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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