drugset / Trial / NCT07555730

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

NCT07555730

Phase 4 Not yet recruiting 400 enrolled Huazhong University of Science and Technology
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2026-04-30
Primary completion
2028-09-30
Completion
2028-09-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tirzepatide Peptide 5 mg Subcutaneous