A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMP… (NCT07654374) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)
United States1,100 participantsStarted 2026-07
Plain-language summary
This is randomized, double-blind, placebo-controlled study of the long-term efficacy, safety, and tolerability of multiple doses of aleniglipron in participants living with overweight or obesity and T2DM. Participants will be randomized to aleniglipron or placebo for a total of 76 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
* Have a BMI ≥27.0 kg/m2 at Screening
* Have a diagnosis of T2DM according to the WHO classification or other locally applicable standards, with HbA1c ≥6.5% (≥53 mmol/mol) to ≤10% (86 mmol/mol) at Screening
Exclusion Criteria:
* Have type 1 diabetes, history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
* Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 180 days prior to Screening.
* Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
* Self-reported change in body weight \>5 kg (11 pounds) within 3 months before Screening.
* Have prior or planned surgical or non-surgical treatment for obesity.
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.
1Since this is a Phase 3 trial testing aleniglipron specifically in people with both obesity or overweight AND type 2 diabetes, is my current combination of conditions and health history the right fit to even consider discussing enrollment when the study opens?
2This trial hasn't started recruiting yet — given where my diabetes and weight management stand right now, should I be pursuing an available treatment option first, or would it make sense to wait and see if I might be a candidate for this study?
3The main thing this trial is measuring is percent change in body weight from the starting point — can you help me understand what that means in practical terms for someone at my weight, and how that compares to what I might expect from treatments already available to me?
4Aleniglipron appears to be a newer investigational drug, so what do you know about its safety profile so far, and what kinds of side effects or risks should I be prepared to discuss before deciding whether to look into this trial further?
5Since this study isn't recruiting yet, is there a way for us to keep track of when it opens so we can revisit whether it might be worth considering as part of my overall treatment plan?
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 body weight from Baseline
Timeframe: Baseline and week 76
Trial details
NCT IDNCT07654374
SponsorGasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics