RECRUITING

Aleniglipron Phase 2 Body Composition Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2, Randomized, Double-blind, Placebo-controlled, Study Evaluating the Effects of Aleniglipron (GSBR-1290) on Body Composition in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2)

Quick Facts

Study Start:2025-08-15
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07169942

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 79 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed informed consent
  2. * Participants age ≥18 years and \<80 years, with BMI ≥30 kg/m2
  3. * Screening HbA1c \<6.5 %
  1. * Previous documented diagnosis of diabetes mellitus
  2. * Self-reported change in body weight \>5% within 3 months before Screening
  3. * 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
  4. * Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed \>1 year prior to screening)
  5. * Have obesity induced by other endocrine disorders (such as Cushing's syndrome, Prader-Willi syndrome, or melanocortin 4 receptor deficiency)

Contacts and Locations

Study Contact

Medical Director
CONTACT
1-650-457-1959
GSBRClinicalTrials@structuretx.com

Study Locations (Sites)

Research Site
Phoenix, Arizona, 85020
United States
Research Site
Chicago, Illinois, 60602
United States
Research Site
Richfield, Minnesota, 55423
United States
Research Site
City of Saint Peters, Missouri, 63303
United States
Research Site
Rochester, New York, 14609
United States
Research Site
Wilmington, North Carolina, 28401
United States
Research Site
Norman, Oklahoma, 73069
United States
Research Site
Moncks Corner, South Carolina, 29461
United States
Research Site
North Charleston, South Carolina, 29405
United States
Research Site
Austin, Texas, 78704
United States
Research Site
San Antonio, Texas, 78240
United States

Collaborators and Investigators

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-15
Study Completion Date2026-10

Study Record Updates

Study Start Date2025-08-15
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Obesity, Overweight, or Chronic Weight Management