Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)

NCT07654361 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: GSBR-1290-12
• Study Type: interventional
• Target: 3,600
• Locations: 1 country
• Sites: 71

Brief Summary

Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie diet and increased physical activity. All participants will be randomized to at least 76 weeks of treatment to evaluate the effects on long term body weight changes, tolerability, and safety. In addition, the study will compare the effects between aleniglipron and placebo on blood pressure (BP), lipid parameters, patient-reported outcomes.

Conditions

Obesity, Overweight, or Chronic Weight Management

Keywords

Obesity, overweight, GSBR-1290, aleniglipron, chronic weight management, obese, small molecule, GLP-1 receptor agonist, Structure Therapeutics

Outcome Measures

Primary Outcomes (1)

• Percent change in body weight from Baseline

  Baseline and Week 76

Secondary Outcomes (14)

• Change in body weight (absolute) from Baseline

  Baseline and week 76

• Percentage of participants who achieve ≥5% reduction in body weight

  Baseline and week 76

• Percentage of participants who achieve ≥10% reduction in body weight

  Baseline and week 76

• Percentage of participants who achieve ≥15% reduction in body weight

  Baseline and week 76

• Percentage of participants who achieve ≥20% reduction in body weight

  Baseline and week 76

Other Outcomes (1)

• Percentage of participants who achieve ≥25% reduction in body weight

  Baseline and week 76

Study Arms (4)

Arm 1

EXPERIMENTAL

Participants will receive aleniglipron administered orally.

Drug: Aleniglipron

Arm 2

EXPERIMENTAL

Participants will receive aleniglipron administered orally.

Drug: Aleniglipron

Arm 3

EXPERIMENTAL

Participants will receive aleniglipron administered orally.

Drug: Aleniglipron

Arm 4

EXPERIMENTAL

Participants will receive placebo administered orally.

Drug: Placebo

Interventions

Aleniglipron DRUG

Drug: aleniglipron administered orally Drug

Arm 1; Arm 2; Arm 3

Placebo DRUG

Drug: placebo administered orally

Arm 4

Eligibility Criteria

• Age: 18 Years - 79 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities.

You may not qualify if:

• Previously documented diagnosis of type 1 diabetes, type 2 diabetes, or any other type of diabetes.
• Self-reported change in body weight \>5 kg within 3 months before Screening. Have prior or planned surgical or non-surgical treatment for obesity. Have or plan to have endoscopic and/or device-based therapy for obesity. Have obesity induced by other endocrine disorders. Impaired renal function at Screening Chronic malabsorption

Sponsors & Collaborators

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

Study Sites (71)

ACCOMPLISH-1 Research Site

Birmingham, Alabama, 35242, United States

Location

ACCOMPLISH-1 Research Site

Birmingham, Alabama, 35294-3360, United States

Location

ACCOMPLISH-1 Research Site

Phoenix, Arizona, 85225, United States

Location

ACCOMPLISH-1 Research Site

Sun City West, Arizona, 85375, United States

Location

ACCOMPLISH-1 Research Site

Tucson, Arizona, 85741, United States

Location

ACCOMPLISH-1 Research Site

Escondido, California, 92025, United States

Location

ACCOMPLISH-1 Research Site

Gardena, California, 92708, United States

Location

ACCOMPLISH-1 Research Site

La Jolla, California, 92108, United States

Location

ACCOMPLISH-1 Research Site

Modesto, California, 95355, United States

Location

ACCOMPLISH-1 Research Site

Rolling Hills Estates, California, 90274, United States

Location

ACCOMPLISH-1 Research Site

San Diego, California, 92123, United States

Location

ACCOMPLISH-1 Research Site

Clearwater, Florida, 33756, United States

Location

ACCOMPLISH-1 Research Site

Leesburg, Florida, 34748, United States

Location

ACCOMPLISH-1 Research Site

Miami, Florida, 33136, United States

Location

ACCOMPLISH-1 Research Site

Ocala, Florida, 34470, United States

Location

ACCOMPLISH-1 Research Site

Ocoee, Florida, 34761, United States

Location

ACCOMPLISH-1 Research Site

Pembroke, Florida, 33027, United States

Location

ACCOMPLISH-1 Research Site

Tampa, Florida, 33617, United States

Location

ACCOMPLISH-1 Research Site

Buford, Georgia, 30046, United States

Location

ACCOMPLISH-1 Research Site

Columbus, Georgia, 31904, United States

Location

ACCOMPLISH-1 Research Site

Lawrenceville, Georgia, 30046, United States

Location

ACCOMPLISH-1 Research Site

Union City, Georgia, 30291, United States

Location

ACCOMPLISH-1 Research Site

Woodstock, Georgia, 30189, United States

Location

ACCOMPLISH-1 Research Site

Honolulu, Hawaii, 96814-4526, United States

Location

ACCOMPLISH-1 Research Site

Meridian, Idaho, 83646, United States

Location

ACCOMPLISH-1 Research Site

Rexburg, Idaho, 83440, United States

Location

ACCOMPLISH-1 Research Site

Chicago, Illinois, 60637, United States

Location

ACCOMPLISH-1 Research Site

Iowa City, Iowa, 52242, United States

Location

ACCOMPLISH-1 Research Site

Wichita, Kansas, 67218, United States

Location

ACCOMPLISH-1 Research Site

Louisville, Kentucky, 40213, United States

Location

ACCOMPLISH-1 Research Site

Baton Rouge, Louisiana, 70808, United States

Location

ACCOMPLISH-1 Research Site

Silver Spring, Maryland, 20901-4402, United States

Location

ACCOMPLISH-1 Research Site

Methuen, Massachusetts, 01844, United States

Location

ACCOMPLISH-1 Research Site

Needham, Massachusetts, 02492, United States

Location

ACCOMPLISH-1 Research Site

Ann Arbor, Michigan, 48105-1912, United States

Location

ACCOMPLISH-1 Research Site

Mankato, Minnesota, 56001, United States

Location

ACCOMPLISH-1 Research Site

Richfield, Minnesota, 55423, United States

Location

ACCOMPLISH-1 Research Site

Gulfport, Mississippi, 39503, United States

Location

ACCOMPLISH-1 Research Site

Ridgeland, Mississippi, 39157, United States

Location

ACCOMPLISH-1 Research Site

Chesterfield, Missouri, 63005, United States

Location

ACCOMPLISH-1 Research Site

Hazelwood, Missouri, 63042, United States

Location

ACCOMPLISH-1 Research Site

St Louis, Missouri, 63303-3041, United States

Location

ACCOMPLISH-1 Research Site

Butte, Montana, 59701, United States

Location

ACCOMPLISH-1 Research Site

Missoula, Montana, 59804, United States

Location

ACCOMPLISH-1 Research Site

Omaha, Nebraska, 68198-7400, United States

Location

ACCOMPLISH-1 Research Site

Las Vegas, Nevada, 89128, United States

Location

ACCOMPLISH-1 Research Site

Albany, New York, 12208-3473, United States

Location

ACCOMPLISH-1 Research Site

Brooklyn, New York, 11220, United States

Location

ACCOMPLISH-1 Research Site

Charlotte, North Carolina, 28210, United States

Location

ACCOMPLISH-1 Research Site

Durham, North Carolina, 27710-3000, United States

Location

ACCOMPLISH-1 Research Site

Fayetteville, North Carolina, 28304, United States

Location

ACCOMPLISH-1 Research Site

New Bern, North Carolina, 28562, United States

Location

ACCOMPLISH-1 Research Site

Wilmington, North Carolina, 28401, United States

Location

ACCOMPLISH-1 Research Site

Winston-Salem, North Carolina, 27104, United States

Location

ACCOMPLISH-1 Research Site

Columbus, Ohio, 43213, United States

Location

ACCOMPLISH-1 Research Site

Columbus, Ohio, 43215, United States

Location

ACCOMPLISH-1 Research Site

Moore, Oklahoma, 73160, United States

Location

ACCOMPLISH-1 Research Site

Portland, Oregon, 97202, United States

Location

ACCOMPLISH-1 Research Site

Philadelphia, Pennsylvania, 19152, United States

Location

ACCOMPLISH-1 Research Site

Greer, South Carolina, 29651, United States

Location

ACCOMPLISH-1 Research Site

Knoxville, Tennessee, 37920, United States

Location

ACCOMPLISH-1 Research Site

Austin, Texas, 78704, United States

Location

ACCOMPLISH-1 Research Site

Austin, Texas, 78731, United States

Location

ACCOMPLISH-1 Research Site

Denison, Texas, 75020-4582, United States

Location

ACCOMPLISH-1 Research Site

Houston, Texas, 77040, United States

Location

ACCOMPLISH-1 Research Site

Houston, Texas, 77054, United States

Location

ACCOMPLISH-1 Research Site

San Antonio, Texas, 78231, United States

Location

ACCOMPLISH-1 Research Site

Wylie, Texas, 75098, United States

Location

ACCOMPLISH-1 Research Site

Sandy City, Utah, 84094, United States

Location

ACCOMPLISH-1 Research Site

St. George, Utah, 84790, United States

Location

ACCOMPLISH-1 Research Site

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Medical Director

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2029
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data sharing requests will be considered beginning 36 months after the study publication (manuscript accepted for publication) and either 1) the product has been granted marketing authorization in at least two regulatory jurisdictions, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Researchers will submit a request containing the research objectives, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). Gasherbrum Bio, Inc. does not grant external requests for individual de-identified patient data for the following purposes: * Re-evaluating safety and efficacy end points already addressed in the product labelling, * Assessing safety or efficacy for an indication in current development Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a panel of external advisors. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement.

Locations

US (71)