AI-assisted Multi-domain Lifestyle Versus Tirzepatide for Weight Loss Maintenance in Adults With Type 2 Diabetes (AIM-MAINTAIN)

Starting soon · Phase 4

Conditions studied: Overweight or Obesity; Type 2 Diabetes, Weight Loss Maintenance

In brief

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

Key facts

Study ID

NCT07555730

Run by

Huazhong University of Science and Technology

People needed

400

Starts

2026-04-30

Expected to finish

2028-09-30

Last updated by the study team

2026-04-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• History of type 1 diabetes mellitus or other types of diabetes, or treatment with insulin.
• History of obesity attributable to endocrine disorders or monogenic mutations.
• 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 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.
• 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
• 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.
• 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.
• Female patients who are pregnant, lactating, or planning to become pregnant within the next two years.

Where it is running

• Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China

Full record on ClinicalTrials.gov

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