About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- AI assisted multi-domain lifestyle intervention
- Tirzepatide