AI-Assisted Lifestyle Intervention Versus Tirzepatide for Obesity and Newly Diagnosed Type 2 Diabetes

What this study is testing ClinicalTrials.gov NCT07697391 ↗

Description as written by the study sponsor.

This multicenter randomized controlled trial will evaluate whether an AI-assisted intensive lifestyle intervention can improve weight and glycemic management in adults with obesity and newly diagnosed type 2 diabetes, compared with tirzepatide treatment and standard lifestyle management. Eligible participants will be adults aged 18 to 65 years with a body mass index of 28 to less than 40 kg/m² and newly diagnosed type 2 diabetes who have not used glucose-lowering medications in the past 3 months. Participants will be randomly assigned to one of three groups: an AI-assisted intensive lifestyle intervention group, a tirzepatide treatment group, or a standard lifestyle management control group. The intervention period will last 52 weeks, followed by a 12-week post-intervention follow-up period. The main outcome is the percentage change in body weight at week 52. The study will also assess glycemic control, body composition, continuous glucose monitoring metrics, safety, and other metabolic outcomes.

Treatments tested

• AI-Assisted Intensive Lifestyle Intervention Behavioral

  An intensive lifestyle intervention supported by an AI-based platform and nutritionist follow-up, including individualized dietary guidance, lifestyle behavior support, and weight management counseling.

• Tirzepatide Drug

  Tirzepatide will be administered by subcutaneous injection once weekly according to the protocol-defined dose titration and tolerability assessment.

• Standard Lifestyle Management Behavioral

  Standardized lifestyle management and health education, including general dietary, physical activity, and weight management advice according to the study protocol.