AI-assisted Multi-domain Lifestyle Versus Tirzepatide for Weight Loss Maintenance in Adults With … (NCT07555730) | Clinical Trial Compass
Not Yet RecruitingPhase 4
AI-assisted Multi-domain Lifestyle Versus Tirzepatide for Weight Loss Maintenance in Adults With Type 2 Diabetes (AIM-MAINTAIN)
China400 participantsStarted 2026-04-30
Plain-language summary
This is a randomized controlled trial to compare the effect of AI-assisted multi-domain lifestyle and continued tirzepatide on body weight loss maintenance. The study consists of two phases: a 20-week lead-in phase, during which all participants will receive weekly subcutaneous tirzepatide at the maximum tolerated dose (MTD), followed by a 52-week intervention phase.
Participants who meet the randomization criteria after the lead-in phase will be randomly assigned to either AI-assisted multi-domain lifestyle intervention or tirzepatide 5 mg
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male or female participants aged 18 to 65 years at the time of signing informed consent;
✓. Body Mass Index (BMI) ≥27.0 kg/m²;
✓. Type 2 diabetes mellitus diagnosed by physicians within the past 5 years prior to screening.
✓. Voluntary participation and provide written informed consent.
Exclusion criteria
✕. History of type 1 diabetes mellitus or other types of diabetes, or treatment with insulin.
✕. History of obesity attributable to endocrine disorders or monogenic mutations.
✕. A self-reported change in body weight ≥5.0% within 3 months prior to the day of screening.
✕. Use of medications or products causing weight changes or affecting weight assessment within 3 months prior to the day of screening;
✕. History of major adverse cardiovascular or cerebrovascular events within 6 months before screening (e.g., angina, myocardial infarction, arrhythmia, stroke, intracranial hemorrhage).
What they're measuring
1
Body weight change (kg)
Timeframe: Change from randomization (week 20) to week 72
Trial details
NCT IDNCT07555730
SponsorHuazhong University of Science and Technology
✕. History of acute or chronic pancreatitis, pancreatic injury, or other high-risk factors for pancreatitis.
✕. History of cancers (except for localized basal cell carcinoma, adenocarcinoma in situ of cervix or prostate carcinoma in situ); personal or family history of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia syndrome (MEN2), or history of thyroid nodules (category IV or higher).
✕. History of organ transplantation, congenital or acquired immunodeficiency disorders.