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

Recruiting · NCT07654374 · Interventional (participants receive a specific treatment) · Lead sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

View the official record on ClinicalTrials.gov →

Type 2 diabetes Obesity

Interventions studied

Placeboaleniglipron

What this trial is 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.

Who can take part

Age range

18 Years to 79 Years

Sex

All (male and female)

Healthy volunteers

Yes - healthy volunteers may be accepted

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

60 locations listed across 30 US states.

ACCOMPLISH-2 Research Site - Birmingham, Alabama, United States
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 - La Jolla, 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 - 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 - Union City, Georgia, United States
ACCOMPLISH-2 Research Site - Woodstock, Georgia, United States
ACCOMPLISH-2 Research Site - Meridian, Idaho, United States
ACCOMPLISH-2 Research Site - Des Moines, Iowa, United States
ACCOMPLISH-2 Research Site - Iowa City, Iowa, United States
ACCOMPLISH-2 Research Site - Wichita, Kansas, United States
ACCOMPLISH-2 Research Site - Silver Spring, Maryland, United States
ACCOMPLISH-2 Research Site - Methuen, Massachusetts, United States
ACCOMPLISH-2 Research Site - Mankato, Minnesota, United States
ACCOMPLISH-2 Research Site - Minneapolis, Minnesota, United States
ACCOMPLISH-2 Research Site - Gulfport, Mississippi, United States
ACCOMPLISH-2 Research Site - Ridgeland, Mississippi, United States
ACCOMPLISH-2 Research Site - Chesterfield, Missouri, United States
ACCOMPLISH-2 Research Site - City of Saint Peters, Missouri, United States
ACCOMPLISH-2 Research Site - Hazelwood, Missouri, United States
ACCOMPLISH-2 Research Site - Springfield, Missouri, United States
ACCOMPLISH-2 Research Site - St Louis, Missouri, United States
ACCOMPLISH-2 Research Site - Missoula, Montana, United States
ACCOMPLISH-2 Research Site - Omaha, Nebraska, United States
ACCOMPLISH-2 Research Site - Las Vegas, Nevada, United States
ACCOMPLISH-2 Research Site - Albany, New York, United States
ACCOMPLISH-2 Research Site - Albany, New York, United States
ACCOMPLISH-2 Research Site - Brooklyn, New York, United States
ACCOMPLISH-2 Research Site - The Bronx, New York, United States
ACCOMPLISH-2 Research Site - Charlotte, North Carolina, United States
ACCOMPLISH-2 Research Site - Durham, North Carolina, United States
ACCOMPLISH-2 Research Site - Fayetteville, North Carolina, United States
ACCOMPLISH-2 Research Site - Morehead City, North Carolina, United States
ACCOMPLISH-2 Research Site - Winston-Salem, North Carolina, United States
ACCOMPLISH-2 Research Site - Columbus, Ohio, United States
ACCOMPLISH-2 Research Site - Moore, Oklahoma, United States
ACCOMPLISH-2 Research Site - Tulsa, Oklahoma, United States
ACCOMPLISH-2 Research Site - Yukon, Oklahoma, United States
ACCOMPLISH-2 Research Site - Portland, Oregon, United States
ACCOMPLISH-2 Research Site - Philadelphia, Pennsylvania, United States

Showing 60 of 74 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →