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NCT07654374PHASE3RecruitingAccepts Healthy Volunteers

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

Start Date

7/17/2026

Completion Date

11/1/2028

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.

Eligibility Criteria

Age Range: 18 years to 79 years

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.

Interventions

DRUG

aleniglipron

DRUG

aleniglipron

DRUG

aleniglipron

DRUG

Placebo

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Conditions

ObesityOverweightChronic Weight ManagementType2 Diabetes Mellitus

Locations

ACCOMPLISH-2 Research Site

Birmingham, Alabama 35242

United States

ACCOMPLISH-2 Research Site

Chandler, Arizona 85225

United States

ACCOMPLISH-2 Research Site

Phoenix, Arizona 85028

United States

ACCOMPLISH-2 Research Site

Sun City West, Arizona 85375

United States

ACCOMPLISH-2 Research Site

Tucson, Arizona 85741

United States

ACCOMPLISH-2 Research Site

Little Rock, Arkansas 72211

United States

ACCOMPLISH-2 Research Site

Escondido, California 92025

United States

ACCOMPLISH-2 Research Site

Fountain Valley, California 92708

United States

ACCOMPLISH-2 Research Site

La Jolla, California 92123

United States

ACCOMPLISH-2 Research Site

Lake Forest, California 92630

United States

ACCOMPLISH-2 Research Site

Rolling Hills Estates, California 90274

United States

ACCOMPLISH-2 Research Site

San Diego, California 92108

United States

ACCOMPLISH-2 Research Site

Tustin, California 92780

United States

ACCOMPLISH-2 Research Site

Waterbury, Connecticut 06708

United States

ACCOMPLISH-2 Research Site

Clearwater, Florida 33756

United States

ACCOMPLISH-2 Research Site

Fort Myers, Florida 33912

United States

ACCOMPLISH-2 Research Site

Jacksonville, Florida 32216

United States

ACCOMPLISH-2 Research Site

Leesburg, Florida 34748

United States

ACCOMPLISH-2 Research Site

Miami, Florida 33136

United States

ACCOMPLISH-2 Research Site

Ocala, Florida 34470

United States

ACCOMPLISH-2 Research Site

Ocoee, Florida 34761

United States

ACCOMPLISH-2 Research Site

Pembroke Pines, Florida 33027

United States

ACCOMPLISH-2 Research Site

Atlanta, Georgia 30329

United States

ACCOMPLISH-2 Research Site

Columbus, Georgia 31904

United States

ACCOMPLISH-2 Research Site

Lawrenceville, Georgia 30046

United States

ACCOMPLISH-2 Research Site

Union City, Georgia 30291

United States

ACCOMPLISH-2 Research Site

Woodstock, Georgia 30189

United States

ACCOMPLISH-2 Research Site

Meridian, Idaho 83646

United States

ACCOMPLISH-2 Research Site

Des Moines, Iowa 50314

United States

ACCOMPLISH-2 Research Site

Iowa City, Iowa 52242

United States

ACCOMPLISH-2 Research Site

Wichita, Kansas 67218

United States

ACCOMPLISH-2 Research Site

Silver Spring, Maryland 20901

United States

ACCOMPLISH-2 Research Site

Methuen, Massachusetts 01844

United States

ACCOMPLISH-2 Research Site

Mankato, Minnesota 56001

United States

ACCOMPLISH-2 Research Site

Minneapolis, Minnesota 55423

United States

ACCOMPLISH-2 Research Site

Gulfport, Mississippi 39503

United States

ACCOMPLISH-2 Research Site

Ridgeland, Mississippi 39157

United States

ACCOMPLISH-2 Research Site

Chesterfield, Missouri 63005

United States

ACCOMPLISH-2 Research Site

City of Saint Peters, Missouri 63303

United States

ACCOMPLISH-2 Research Site

Hazelwood, Missouri 63042

United States

ACCOMPLISH-2 Research Site

Springfield, Missouri 65807

United States

ACCOMPLISH-2 Research Site

St Louis, Missouri 63141

United States

ACCOMPLISH-2 Research Site

Missoula, Montana 59804

United States

ACCOMPLISH-2 Research Site

Omaha, Nebraska 68105

United States

ACCOMPLISH-2 Research Site

Las Vegas, Nevada 89128

United States

ACCOMPLISH-2 Research Site

Albany, New York 12206

United States

ACCOMPLISH-2 Research Site

Albany, New York 12208

United States

ACCOMPLISH-2 Research Site

Brooklyn, New York 11220

United States

ACCOMPLISH-2 Research Site

The Bronx, New York 10455

United States

ACCOMPLISH-2 Research Site

Charlotte, North Carolina 28210

United States

ACCOMPLISH-2 Research Site

Durham, North Carolina 27710

United States

ACCOMPLISH-2 Research Site

Fayetteville, North Carolina 28304

United States

ACCOMPLISH-2 Research Site

Morehead City, North Carolina 23730

United States

ACCOMPLISH-2 Research Site

Winston-Salem, North Carolina 27104

United States

ACCOMPLISH-2 Research Site

Columbus, Ohio 43213

United States

ACCOMPLISH-2 Research Site

Moore, Oklahoma 73160

United States

ACCOMPLISH-2 Research Site

Tulsa, Oklahoma 74133

United States

ACCOMPLISH-2 Research Site

Yukon, Oklahoma 73099

United States

ACCOMPLISH-2 Research Site

Portland, Oregon 97202

United States

ACCOMPLISH-2 Research Site

Philadelphia, Pennsylvania 19152

United States

ACCOMPLISH-2 Research Site

Greer, South Carolina 29651

United States

ACCOMPLISH-2 Research Site

Nashville, Tennessee 37203

United States

ACCOMPLISH-2 Research Site

Austin, Texas 78704

United States

ACCOMPLISH-2 Research Site

Farmers Branch, Texas 75234

United States

ACCOMPLISH-2 Research Site

Houston, Texas 77040

United States

ACCOMPLISH-2 Research Site

Houston, Texas 77054

United States

ACCOMPLISH-2 Research Site

San Antonio, Texas 78229

United States

ACCOMPLISH-2 Research Site

San Antonio, Texas 78230

United States

ACCOMPLISH-2 Research Site

Wylie, Texas 75098

United States

ACCOMPLISH-2 Research Site

Salt Lake City, Utah 84107

United States

ACCOMPLISH-2 Research Site

Burke, Virginia 22015

United States

ACCOMPLISH-2 Research Site

Manassas, Virginia 20110

United States

ACCOMPLISH-2 Research Site

Suffolk, Virginia 23435

United States

ACCOMPLISH-2 Research Site

Renton, Washington 98057

United States