Recruiting

Phase 3

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

Sponsor:

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

Code:

NCT07654374

Conditions

Obesity

Overweight

Chronic Weight Management

Type2 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

aleniglipron

Placebo

Study Details

Brief summary:

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.

Conditions

Obesity

Overweight

Chronic Weight Management

Type2 Diabetes Mellitus

Study ID

NCT07654374

Start date

Jul 17, 2026

Status verified date

Jun, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: aleniglipron Arm 1

Participants will receive aleniglipron administered orally.

experimental: aleniglipron Arm 2

Participants will receive aleniglipron administered orally.

experimental: aleniglipron Arm 3

Participants will receive aleniglipron administered orally.

placebo comparator: Placebo Arm 4

Participants will receive placebo administered orally.

Interventions

aleniglipron

Drug: aleniglipron administered orally

aleniglipron

Drug: aleniglipron administered orally

aleniglipron

Drug: aleniglipron administered orally

Placebo

Drug: placebo administered orally

Primary outcome measure

Percent change in body weight from Baseline [ Time Frame: Baseline and week 76 ]

Central Contacts and Locations

Central contacts

Medical Director

1-650-457-1959 GSBRClinicalTrials@structuretx.com

Locations

ACCOMPLISH-2 Research Site

Recruiting

Birmingham, Alabama, United States, 35242

Contacts

Medical Director

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

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information