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

Sponsor
Huazhong University of Science and Technology
Study ID
NCT07555730
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Overweight or Obesity; Type 2 Diabetes
  • Weight Loss Maintenance

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • AI assisted multi-domain lifestyle intervention — BEHAVIORAL
    AI-assisted multi-domain lifestyle interventions that integrate dietary, physical activity, and psychological components.
  • Tirzepatide — DRUG
    Administered subcutaneously.

Study Details

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

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AI assisted multi-domain lifestyle intervention
    Participants will be randomized to receive multi-domain lifestyle intervention including diet, physical activity and psychological support for 52 weeks. Additionally, the weight loss maintenance program will integrate AI-assisted nutritional analysis to facilitate long-term weight management.
  • Active Comparator: Tirzepatide
    Participants will be randomized to receive tirzepatide 5 mg treatment for 52 weeks.

Primary Outcome Measure

Body weight change (kg) [ Time Frame: Change from randomization (week 20) to week 72 ]

Central Contacts

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