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
2 other identifiers
interventional
285
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 obesity
Started Jul 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2026
CompletedFirst Posted
Study publicly available on registry
July 13, 2026
CompletedStudy Start
First participant enrolled
July 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
July 13, 2026
July 1, 2026
1.3 years
July 6, 2026
July 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Change in HbA1c From Baseline to Week 52
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
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
Week 64
- +6 more secondary outcomes
Study Arms (3)
AI-Assisted Intensive Lifestyle Intervention
EXPERIMENTALParticipants 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.
Tirzepatide Treatment
ACTIVE COMPARATORParticipants in this arm will receive tirzepatide treatment according to the study protocol, in addition to standardized lifestyle education.
Standard Lifestyle Management
ACTIVE COMPARATORParticipants in this arm will receive standardized lifestyle management and health education according to the study protocol.
Interventions
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 will be administered by subcutaneous injection once weekly according to the protocol-defined dose titration and tolerability assessment.
Standardized lifestyle management and health education, including general dietary, physical activity, and weight management advice according to the study protocol.
Eligibility Criteria
You may qualify if:
- 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.
- Able to communicate with the investigators, willing to comply with the study protocol, and voluntarily sign the informed consent form.
You may not qualify if:
- 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.
- Severe cardiovascular or cerebrovascular events within 6 months before screening, including angina, myocardial infarction, arrhythmia, cerebral infarction, cerebral hemorrhage, or other clinically significant events.
- History of acute or chronic pancreatitis, history of pancreatic injury, or amylase \>1.5 × upper limit of normal at screening.
- 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.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, or history of thyroid nodules.
- Blood dyscrasia or any disease causing hemolysis or unstable red blood cells, or hemoglobinopathy that may affect HbA1c measurement.
- History of organ transplantation or acquired or congenital immune system disease.
- Schizophrenia or other psychiatric disorder that may interfere with participation in the study.
- Unstable or treatment-requiring endocrine disease related to glycemic control, such as hyperthyroidism, acromegaly, or Cushing syndrome, as judged by the investigator.
- Hypertension with systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>90 mmHg after stable antihypertensive treatment.
- 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.
- Special dietary requirements or allergy to foods such as soy products or dairy products.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2026
First Posted
July 13, 2026
Study Start
July 20, 2026
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
January 31, 2028
Last Updated
July 13, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared because of participant privacy protection, ethical restrictions, and institutional data governance requirements.