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

Prior treatment

• 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.

Other illness

• 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.

Lab values

• 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

Other

• 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.

• 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.