AI-Assisted Lifestyle Intervention Versus Tirzepatide for Obesity and Newly Diagnosed Type 2 Diabetes (AI-LIFE-T2D-OB)

A Multicenter Randomized Controlled Trial Evaluating AI-Assisted Intensive Lifestyle Intervention Versus Tirzepatide for Glycemic and Weight Management in Patients With Obesity and Newly Diagnosed Type 2 Diabetes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: AI-Assisted Intensive Lifestyle Intervention; Behavioral: Standard Lifestyle Management; Drug: Tirzepatide

• Study Type: Interventional
• Enrollment (Estimated): 285
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xueying Zheng; Phone Number: +8619966188536; Email: lisazhengxy@163.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • The First Affiliated Hospital of Anhui Medical University
      • Contact: Meiwen He; Phone Number: +8619966188536; Email: hemeiwen0128@163.com
    • Hefei, Anhui, China, 230601
      • The Second Affiliated Hospital of Anhui Medical University
      • Contact: Meiwen He; Phone Number: +8619966188536; Email: hemeiwen0128@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female participants aged 18 to 65 years.
2. 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.
3. Body mass index ≥28 kg/m² and <40 kg/m².
4. 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.
5. Able to communicate with the investigators, willing to comply with the study protocol, and voluntarily sign the informed consent form.

Exclusion Criteria:

1. Type 1 diabetes mellitus, type 2 diabetes requiring insulin treatment, or other specific types of diabetes.
2. Body weight change >5% within 12 weeks before screening.
3. Pregnant or breastfeeding women.
4. Severe trauma, severe infection, or surgery within 1 month before screening that may affect glycemic control.
5. Severe cardiovascular or cerebrovascular events within 6 months before screening, including angina, myocardial infarction, arrhythmia, cerebral infarction, cerebral hemorrhage, or other clinically significant events.
6. History of acute or chronic pancreatitis, history of pancreatic injury, or amylase >1.5 × upper limit of normal at screening.
7. Current or previous malignancy, except local basal cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the prostate; diagnosis of malignancy within 5 years before screening.
8. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, or history of thyroid nodules.
9. Blood dyscrasia or any disease causing hemolysis or unstable red blood cells, or hemoglobinopathy that may affect HbA1c measurement.
10. History of organ transplantation or acquired or congenital immune system disease.
11. Schizophrenia or other psychiatric disorder that may interfere with participation in the study.
12. Unstable or treatment-requiring endocrine disease related to glycemic control, such as hyperthyroidism, acromegaly, or Cushing syndrome, as judged by the investigator.
13. Hypertension with systolic blood pressure >150 mmHg and/or diastolic blood pressure >90 mmHg after stable antihypertensive treatment.
14. Clinically significant abnormal gastric emptying, severe chronic gastrointestinal disease, diabetic gastroparesis, long-term use of medications directly affecting gastrointestinal motility, or history of gastrointestinal surgery.
15. Special dietary requirements or allergy to foods such as soy products or dairy products.
16. Use of medications affecting glucose regulation within 3 months before randomization, such as glucocorticoids, growth hormone, thyroid hormone, sex hormones, cyclosporine, or phenytoin.
17. Allergic constitution, defined as allergy to two or more categories of substances.
18. Fasting C-peptide <0.81 ng/mL.
19. Calcitonin ≥50 pg/mL.
20. Abnormal laboratory results, including AST or ALT >2.5 × upper limit of normal, bilirubin >2.5 × upper limit of normal, triglycerides ≥5.7 mmol/L, estimated creatinine clearance <60 mL/min using the Cockcroft-Gault formula, or clinically significant anemia with hemoglobin <120 g/L in men or <110 g/L in women.
21. Unstable proliferative retinopathy or maculopathy requiring urgent treatment within 1 year before randomization, or history of diabetic ketoacidosis, hyperosmolar nonketotic coma, or severe metabolic disorder causing neuropsychiatric dysfunction.
22. History or risk factors of epilepsy, syncope, cardiac arrest, arrhythmia, atrioventricular block, structural heart disease, torsades de pointes, hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, or hypocalcemia.
23. Active bacterial, viral, or fungal infection requiring hospitalization or intravenous antibiotic treatment.
24. Positive HBsAg, HCV antibody, HIV antibody, or Treponema pallidum antibody.
25. Positive urine drug screening and/or drug dependence.
26. Participation in another clinical trial within 3 months before enrollment or current participation in another drug or device clinical trial.
27. Any other condition that, in the investigator's opinion, makes the participant unsuitable for this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: AI-Assisted Intensive Lifestyle Intervention; 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.; Behavioral: Standard Lifestyle Management; Standardized lifestyle management and health education, including general dietary, physical activity, and weight management advice according to the study protocol.
Active Comparator: Tirzepatide Treatment; Participants in this arm will receive tirzepatide treatment according to the study protocol, in addition to standardized lifestyle education.	Behavioral: Standard Lifestyle Management; Standardized lifestyle management and health education, including general dietary, physical activity, and weight management advice according to the study protocol.; Drug: Tirzepatide; Tirzepatide will be administered by subcutaneous injection once weekly according to the protocol-defined dose titration and tolerability assessment.
Active Comparator: Standard Lifestyle Management; Participants in this arm will receive standardized lifestyle management and health education according to the study protocol.	Behavioral: Standard Lifestyle Management; Standardized lifestyle management and health education, including general dietary, physical activity, and weight management advice according to the study protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c From Baseline to Week 52	Change in glycated hemoglobin from baseline to week 52.	Baseline to Week 52
Change in Fasting Plasma Glucose From Baseline to Week 52	Change in fasting plasma glucose from baseline to week 52.	Baseline to Week 52
Change in Waist Circumference From Baseline to Week 52	Change in waist circumference from baseline to week 52.	Baseline to Week 52
Change in Body Mass Index From Baseline to Week 52	Change in body mass index from baseline to week 52.	Baseline to Week 52
Proportion of Participants Achieving Type 2 Diabetes Remission at Week 64	Type 2 diabetes remission is defined as HbA1c <6.5% at week 64 without the use of glucose-lowering medications for at least 3 months before the assessment. Participants who receive rescue glucose-lowering therapy before week 64 will be considered not achieving remission.	Week 64
Change in CGM Time in Range From Baseline to Week 52	Change in the percentage of continuous glucose monitoring time with glucose values between 3.9 and 10.0 mmol/L from baseline to week 52.	Baseline to Week 52
Change in CGM Time Above Range From Baseline to Week 52	Change in the percentage of continuous glucose monitoring time with glucose values above 10.0 mmol/L from baseline to week 52.	Baseline to Week 52
Change in CGM Time Below Range From Baseline to Week 52	Change in the percentage of continuous glucose monitoring time with glucose values below 3.9 mmol/L from baseline to week 52.	Baseline to Week 52
Change in CGM Coefficient of Variation From Baseline to Week 52	Change in the coefficient of variation of continuous glucose monitoring glucose values from baseline to week 52. The coefficient of variation will be expressed as a percentage.	Baseline to Week 52
Incidence of Adverse Events	The proportion of participants who experience at least one adverse event during the study period.	From enrollment to Week 64
Incidence of Serious Adverse Events	The proportion of participants who experience at least one serious adverse event during the study period.	From enrollment to Week 64

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Anhui Medical University
• Collaborators: Zhejiang Nutriease Health Technology Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring; Randomized Controlled Trial; Weight Management; Glycemic Control; Tirzepatide; AI-Assisted Lifestyle Intervention
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2; Amino Acids, Peptides, and Proteins; Proteins; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Tirzepatide
• Other Study ID Numbers: FAH-AMU-OBT2D-001; MR-34-26-044995 (Other Identifier: Medical Research Registration and Filing Information System, China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because of participant privacy protection, ethical restrictions, and institutional data governance requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No