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

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

Status and phase: Begins enrollment this month; Phase 3

Conditions: Obesity, Overweight, or Chronic Weight Management, T2DM

Treatments: Drug: Placebo; Drug: aleniglipron

Study type: Interventional

Funder types: Industry

Identifiers

NCT07654374

GSBR-1290-15

Details and patient eligibility

About

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.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,100 participants in 4 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

Participants will receive aleniglipron administered orally.

Treatment:

Drug: aleniglipron

Drug: aleniglipron

Drug: aleniglipron

Cohort 2

Experimental group

Description:

Participants will receive aleniglipron administered orally.

Treatment:

Drug: aleniglipron

Drug: aleniglipron

Drug: aleniglipron

Cohort 3

Experimental group

Description:

Participants will receive aleniglipron administered orally.

Treatment:

Drug: aleniglipron

Drug: aleniglipron

Drug: aleniglipron

Cohort 4

Placebo Comparator group

Description:

Participants will receive placebo administered orally.

Treatment:

Drug: Placebo