A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Obesity, Overweight, Chronic Weight Management, Type2 Diabetes Mellitus

In brief

This is randomized, double-blind, placebo-controlled study of the long-term efficacy, safety, and tolerability of multiple doses of aleniglipron in participants living with overweight or obesity and T2DM. Participants will be randomized to aleniglipron or placebo for a total of 76 weeks of treatment.

Key facts

Study ID

NCT07654374

Run by

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

People needed

1100

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: accepted.

You may qualify if…

• Signed Informed Consent
• Have a BMI ≥27.0 kg/m2 at Screening
• Have a diagnosis of T2DM according to the WHO classification or other locally applicable standards, with HbA1c ≥6.5% (≥53 mmol/mol) to ≤10% (86 mmol/mol) at Screening

You may not qualify if…

• Have type 1 diabetes, history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
• Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 180 days prior to Screening.
• Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
• Self-reported change in body weight >5 kg (11 pounds) within 3 months before Screening.
• Have prior or planned surgical or non-surgical treatment for obesity.

Where it is running

• ACCOMPLISH-2 Research Site — Chandler, Arizona, United States
• ACCOMPLISH-2 Research Site — Phoenix, Arizona, United States
• ACCOMPLISH-2 Research Site — Sun City West, Arizona, United States
• ACCOMPLISH-2 Research Site — Tucson, Arizona, United States
• ACCOMPLISH-2 Research Site — Little Rock, Arkansas, United States
• ACCOMPLISH-2 Research Site — Escondido, California, United States
• ACCOMPLISH-2 Research Site — Fountain Valley, California, United States
• ACCOMPLISH-2 Research Site — Lake Forest, California, United States
• ACCOMPLISH-2 Research Site — Rolling Hills Estates, California, United States
• ACCOMPLISH-2 Research Site — San Diego, California, United States
• ACCOMPLISH-2 Research Site — San Diego, California, United States
• ACCOMPLISH-2 Research Site — Tustin, California, United States
• ACCOMPLISH-2 Research Site — Waterbury, Connecticut, United States
• ACCOMPLISH-2 Research Site — Clearwater, Florida, United States
• ACCOMPLISH-2 Research Site — Fort Myers, Florida, United States
• ACCOMPLISH-2 Research Site — Jacksonville, Florida, United States
• ACCOMPLISH-2 Research Site — Leesburg, Florida, United States
• ACCOMPLISH-2 Research Site — Miami, Florida, United States
• ACCOMPLISH-2 Research Site — Ocala, Florida, United States
• ACCOMPLISH-2 Research Site — Ocoee, Florida, United States
• ACCOMPLISH-2 Research Site — Pembroke Pines, Florida, United States
• ACCOMPLISH-2 Research Site — Atlanta, Georgia, United States
• ACCOMPLISH-2 Research Site — Columbus, Georgia, United States
• ACCOMPLISH-2 Research Site — Lawrenceville, Georgia, United States
• ACCOMPLISH-2 Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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