AI-guided lifestyle program versus tirzepatide for keeping weight off in type 2 diabetes

Trial details

Who runs it

Huazhong University of Science and Technology

Trial code

NCT07555730

Record updated

29 April 2026

Original description

This is a randomized controlled trial to compare the effect of AI-assisted multi-domain lifestyle and continued tirzepatide on body weight loss maintenance. The study consists of two phases: a 20-week lead-in phase, during which all participants will receive weekly subcutaneous tirzepatide at the maximum tolerated dose (MTD), followed by a 52-week intervention phase.Read full original descriptionShow less

Effect of AI-assisted Multi-domain Lifestyle Intervention Versus Tirzepatide Treatment on Weight Loss Maintenance in Adults With Type 2 Diabetes: a Randomized Clinical Trial.

This is a randomized controlled trial to compare the effect of AI-assisted multi-domain lifestyle and continued tirzepatide on body weight loss maintenance. The study consists of two phases: a 20-week lead-in phase, during which all participants will receive weekly subcutaneous tirzepatide at the maximum tolerated dose (MTD), followed by a 52-week intervention phase.

Participants who meet the randomization criteria after the lead-in phase will be randomly assigned to either AI-assisted multi-domain lifestyle intervention or tirzepatide 5 mg

Inclusion: Male or female participants aged 18 to 65 years at the time of signing informed consent; Body Mass Index (BMI) ≥27.0 kg/m²; Type 2 diabetes mellitus diagnosed by physicians within the past 5 years prior to screening; Voluntary participation and provide written informed consent.

Exclusion: History of type 1 diabetes mellitus or other types of diabetes, or treatment with insulin; A self-reported change in body weight ≥5.0% within 3 months prior to the day of screening; Use of medications or products causing weight changes or affecting weight assessment within 3 months prior to the day of screening; History of major adverse cardiovascular or cerebrovascular events within 6 months before screening (e.g., angina, myocardial infarction, arrhythmia, stroke, intracranial hemorrhage); History of uncontrolled and potentially unstable proliferative retinopathy or maculopathy within 1 year prior to screening, or history of diabetic ketoacidosis, diabetic non-ketotic hyperosmolar coma, or severe metabolic disturbances with neurological and psychiatric disorders; Participation in other clinical trial within 3 months before screening or currently enrolled in other clinical trial study; History of drug abuse or alcohol dependence within 6 months before screening; History of obesity attributable to endocrine disorders or monogenic mutations; History of acute or chronic pancreatitis, pancreatic injury, or other high-risk factors for pancreatitis; History of cancers (except for localized basal cell carcinoma, adenocarcinoma in situ of cervix or prostate carcinoma in situ); personal or family history of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia syndrome (MEN2), or history of thyroid nodules (category IV or higher); History of organ transplantation, congenital or acquired immunodeficiency disorders; History of schizophrenia or major depressive disorder or other severe psychiatric disorders; Poorly controlled hypertension at screening (systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg despite at least 4 weeks of conventional antihypertensive therapy); History of clinically significant gastric emptying abnormalities, or history of severe chronic gastrointestinal disease, or history of diabetic gastroparesis, or long-term use of drugs that directly affect gastrointestinal motility, or history of gastrointestinal surgery; Those who are known to be allergic to any component of GLP-1 receptor agonists drugs, or have more than two allergies, or be allergic to soy, dairy, or similar foods; History of clinically significant anemia, or epilepsy, or syncope or cardiac conditions (e.g. cardiac arrest, arrhythmias, atrioventricular block, structural heart disease, torsades de pointes); Patients with active bacterial, viral, or fungal infections requiring hospitalization or antibiotic treatment; History of infectious diseases such as human immunodeficiency virus (HIV), syphilis, or active hepatitis; Laboratory evaluation at screening meet any of the following criteria:; Calcitonin ≥50 pg/mL; Thyroid stimulating hormone (TSH) >6.0 or <0.4 mIU/L; Fasting C-peptide <0.81 ng/mL; Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >2.5 × upper limit of normal (ULN) or total bilirubin (TBIL) >2.5 × ULN (except Gilbert's syndrome with conjugated bilirubin <35%); Triglycerides ≥5.7 mmol/L; Serum amylase >2.5 × ULN; eGFR <30 mL/min/1.73m²; Female patients who are pregnant, lactating, or planning to become pregnant within the next two years; Any other reasons that researchers deem to unsuitable for participation in this study.

ClinicalTrials.gov NCT07555730