Aleniglipron Phase 2 Body Composition Study (NCT07169942) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Aleniglipron Phase 2 Body Composition Study
United States71 participantsStarted 2025-08-15
Plain-language 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.
Who can participate
Age range
18 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent change in total body fat mass by DXA
Timeframe: Baseline and week 44
Trial details
NCT IDNCT07169942
SponsorGasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics