Recruiting
Phase 3

Aleniglipron

Sponsor:

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

Code:

NCT07654361

Conditions

Obesity

Overweight

Chronic Weight Management

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Aleniglipron

Placebo

Study Details

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

Chronic Weight Management

Study ID

NCT07654361

Start date

Jul 13, 2026

Status verified date

Jun, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

3600 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.

experimental: Placebo Arm 4

Participants will receive placebo administered orally.

Interventions

Aleniglipron

Drug: aleniglipron administered orally Drug

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

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

Locations

ACCOMPLISH-1 Research Site

Recruiting

Clearwater, Florida, United States, 33756

Contacts

Medical Director

GSBRClinicalTrials@structuretx.com

ACCOMPLISH-1 Research Site

Recruiting

Honolulu, Hawaii, United States, 96814-4526

Contacts

Medical Director

GSBRClinicalTrials@structuretx.com

ACCOMPLISH-1 Research Site

Recruiting

Silver Spring, Maryland, United States, 20901-4402

Contacts

Medical Director

GSBRClinicalTrials@structuretx.com

ACCOMPLISH-1 Research Site

Recruiting

Mankato, Minnesota, United States, 56001

Contacts

Medical Director

GSBRClinicalTrials@structuretx.com

ACCOMPLISH-1 Research Site

Recruiting

Richfield, Minnesota, United States, 55423

Contacts

Medical Director

GSBRClinicalTrials@structuretx.com

ACCOMPLISH-1 Research Site

Recruiting

Hazelwood, Missouri, United States, 63042

Contacts

Medical Director

GSBRClinicalTrials@structuretx.com

ACCOMPLISH-1 Research Site

Recruiting

St Louis, Missouri, United States, 63303-3041

Contacts

Medical Director

GSBRClinicalTrials@structuretx.com

ACCOMPLISH-1 Research Site

Recruiting

Charlotte, North Carolina, United States, 28210

Contacts

Medical Director

GSBRClinicalTrials@structuretx.com

ACCOMPLISH-1 Research Site

Recruiting

Wilmington, North Carolina, United States, 28401

Contacts

Medical Director

GSBRClinicalTrials@structuretx.com

ACCOMPLISH-1 Research Site

Recruiting

Columbus, Ohio, United States, 43215

Contacts

Medical Director

GSBRClinicalTrials@structuretx.com

ACCOMPLISH-1 Research Site

Recruiting

Portland, Oregon, United States, 97202

Contacts

Medical Director

GSBRClinicalTrials@structuretx.com

ACCOMPLISH-1 Research Site

Recruiting

Austin, Texas, United States, 78731

Contacts

Medical Director

GSBRClinicalTrials@structuretx.com

ACCOMPLISH-1 Research Site

Recruiting

Renton, Washington, United States, 98057

Contacts

Medical Director

GSBRClinicalTrials@structuretx.com

More Information

Sponsor

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

Last update posted

Aug 10, 2026

Last verified

Jun, 2026

Keywords

  • Obesity
  • Overweight
  • GSBR-1290
  • Aleniglipron
  • Chronic weight management
  • Obese
  • Small molecule
  • GLP-1
  • Structure Therapeutics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics on 2026-08-10.