Aleniglipron Phase 2 Body Composition Study

NCT07169942 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: GSBR-1290-16
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 11

Brief Summary

This is a randomized, double-blind, placebo-controlled study evaluating the effects of aleniglipron on body composition in participants living with obesity. Participants will be randomized to aleniglipron or placebo in a ratio of 5:1. Participants will receive multiple ascending QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 40 weeks of treatment.

Conditions

Obesity, Overweight, or Chronic Weight Management

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percent change in total body fat mass by DXA

  Baseline and week 44

Secondary Outcomes (4)

• Percent change in visceral adipose tissue [VAT] by DXA

  Baseline and week 44

• Percent change in lean body mass by DXA

  Baseline and week 44

• Percent change in body weight by DXA

  Baseline and week 44

• Percent change in waist circumference

  Baseline and week 44

Other Outcomes (4)

• Change in patient-reported outcome SF-36 acute version

  Baseline and week 44

• Change in patient-reported outcome IWQOL-Lite CT

  Baseline and week 44

• Change in patient-reported outcome hunger/satiety evaluation checklist

  Baseline and week 44

Study Arms (2)

Cohort 1

EXPERIMENTAL

Participants will receive aleniglipron or placebo administered orally.

Drug: aleniglipron or placebo

Cohort 2

EXPERIMENTAL

Participants will receive aleniglipron or placebo administered orally.

Drug: aleniglipron or placebo

Interventions

aleniglipron or placebo DRUG

Drug: aleniglipron administered orally Drug: placebo administered orally

Cohort 1; Cohort 2

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
• Participants age ≥18 years and \<80 years, with BMI ≥30 kg/m2
• Screening HbA1c \<6.5 %

You may not qualify if:

• Previous documented diagnosis of diabetes mellitus
• Self-reported change in body weight \>5% within 3 months before Screening
• Have a body weight, height, and/or width that prohibits the ability to obtain accurate measurements according to the DXA study specific manual that allows hemi-scan
• Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed \>1 year prior to screening)
• Have obesity induced by other endocrine disorders (such as Cushing's syndrome, Prader-Willi syndrome, or melanocortin 4 receptor deficiency)

Sponsors & Collaborators

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

Study Sites (11)

Research Site

Phoenix, Arizona, 85020, United States

Location

Research Site

Chicago, Illinois, 60602, United States

Location

Research Site

Richfield, Minnesota, 55423, United States

Location

Research Site

City of Saint Peters, Missouri, 63303, United States

Location

Research Site

Rochester, New York, 14609, United States

Location

Research Site

Wilmington, North Carolina, 28401, United States

Location

Research Site

Norman, Oklahoma, 73069, United States

Location

Research Site

Moncks Corner, South Carolina, 29461, United States

Location

Research Site

North Charleston, South Carolina, 29405, United States

Location

Research Site

Austin, Texas, 78704, United States

Location

Research Site

San Antonio, Texas, 78240, 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

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: August 20, 2025
• First Posted: September 12, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2025-10

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 (11)