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NCT Number: NCT07169942

Aleniglipron Phase 2 Body Composition Study

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity, Overweight, or Chronic Weight Management Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

aleniglipron or placebo

Drug

Drug: aleniglipron administered orally Drug: placebo administered orally

Primary outcomes

  1. Percent change in total body fat mass by DXA

    Time frame: Baseline and week 44

Secondary outcomes

  1. Percent change in visceral adipose tissue [VAT] by DXA

    Time frame: Baseline and week 44

  2. Percent change in lean body mass by DXA

    Time frame: Baseline and week 44

  3. Percent change in body weight by DXA

    Time frame: Baseline and week 44

  4. Percent change in waist circumference

    Time frame: Baseline and week 44

Other outcomes

  1. Change in patient-reported outcome SF-36 acute version

    Time frame: Baseline and week 44

  2. Change in patient-reported outcome IWQOL-Lite CT

    Time frame: Baseline and week 44

  3. Change in patient-reported outcome hunger/satiety evaluation checklist

    Time frame: Baseline and week 44

  4. Change in high-density lipoprotein and low-density lipoprotein cholesterol

    Time frame: Baseline and week 44

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 12, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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