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

Sponsor
The First Affiliated Hospital of Anhui Medical University
Study ID
NCT07697391
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jul 13, 2026
Start date
Jul 20, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2027
Completion
Jan 31, 2028

Study Design

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

Arms

  • Experimental: AI-Assisted Intensive Lifestyle Intervention
    Participants in this arm will receive an AI-assisted intensive lifestyle intervention, including individualized dietary and lifestyle guidance supported by an AI-based platform and nutritionist follow-up, in addition to standardized lifestyle education.
  • Active Comparator: Tirzepatide Treatment
    Participants in this arm will receive tirzepatide treatment according to the study protocol, in addition to standardized lifestyle education.
  • Active Comparator: Standard Lifestyle Management
    Participants in this arm will receive standardized lifestyle management and health education according to the study protocol.

Primary Outcome Measure

Percent Change in Body Weight From Baseline to Week 52 [ Time Frame: Baseline to Week 52 ]

Central Contacts

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