AI-assisted Multi-domain Lifestyle Versus Tirzepatide for Weight Loss Maintenance in Adults With Type 2 Diabetes (AIM-MAINTAIN)

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHuazhong University of Science and Technology

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

Treatment groups

400 Participants
are divided into 2 treatment groups