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.
Male or female participants aged 18 to 65 years.
Newly diagnosed type 2 diabetes mellitus, defined as diagnosis within 3 years and no use of glucose-lowering medications within the past 3 months. Diagnosis should meet the 1999 World Health Organization criteria, including at least one of the following: random plasma glucose ≥11.1 mmol/L, fasting blood glucose ≥7.0 mmol/L, 2-hour postprandial blood glucose ≥11.1 mmol/L, or HbA1c ≥6.5% and ≤10.0%. Participants without typical diabetes symptoms should have repeat testing for confirmation.
Body mass index ≥28 kg/m² and <40 kg/m².
Willing to use effective contraception and have no pregnancy plan within 12 months after signing the informed consent form; female participants must have a negative pregnancy test at screening.
Type 1 diabetes mellitus, type 2 diabetes requiring insulin treatment, or other specific types of diabetes.
Body weight change >5% within 12 weeks before screening.
Pregnant or breastfeeding women.
Severe trauma, severe infection, or surgery within 1 month before screening that may affect glycemic control.
Parallel
AI-Assisted Intensive Lifestyle Intervention
BehavioralAn 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
DrugTirzepatide will be administered by subcutaneous injection once weekly according to the protocol-defined dose titration and tolerability assessment.
Standard Lifestyle Management
BehavioralStandardized lifestyle management and health education, including general dietary, physical activity, and weight management advice according to the study protocol.
Percent Change in Body Weight From Baseline to Week 52
Percent change in body weight from baseline to week 52 will be calculated as \[(body weight at week 52 - body weight at baseline) / body weight at baseline\] × 100%. A negative value indicates weight loss.
Change in HbA1c From Baseline to Week 52
Change in glycated hemoglobin from baseline to week 52.
Change in Fasting Plasma Glucose From Baseline to Week 52
Change in fasting plasma glucose from baseline to week 52.
Change in Waist Circumference From Baseline to Week 52
Change in waist circumference from baseline to week 52.
Change in Body Mass Index From Baseline to Week 52
Change in body mass index from baseline to week 52.
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The First Affiliated Hospital of Anhui Medical University
Lead sponsor
Zhejiang Nutriease Health Technology Co. Ltd.
Collaborator
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