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

NCT07555730 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: Lifestyle, Tirzepatide in T2D
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overweight or Obesity; Type 2 Diabetes; Weight Loss Maintenance

Outcome Measures

Primary Outcomes (1)

• Body weight change (kg)

  Weight will be measured to the nearest 0.1 kg

  Change from randomization (week 20) to week 72

Secondary Outcomes (18)

• Percent change in body weight

  Change from randomization (week 20) to week 72

• Body mass index

  Change from randomization (week 20) to week 72

• Waist and hip circumference

  Change from randomization (week 20) to week 72

• Body fat percentage

  Change from randomization (week 20) to week 72

• Skeletal muscle mass

  Change from randomization (week 20) to week 72

Other Outcomes (13)

• Concentration of high-sensitivity C-reactive protein (hs-CRP)

  Change from baseline (week 0) to week 72

• HOMA-IR

  Change from baseline (week 0) to week 72

• HOMA-β

  Change from baseline (week 0) to week 72

Study Arms (2)

AI assisted multi-domain lifestyle intervention

EXPERIMENTAL

Participants will be randomized to receive multi-domain lifestyle intervention including diet, physical activity and psychological support for 52 weeks. Additionally, the weight loss maintenance program will integrate AI-assisted nutritional analysis to facilitate long-term weight management.

Behavioral: AI assisted multi-domain lifestyle intervention

Tirzepatide

ACTIVE COMPARATOR

Participants will be randomized to receive tirzepatide 5 mg treatment for 52 weeks.

Drug: Tirzepatide

Interventions

AI assisted multi-domain lifestyle intervention BEHAVIORAL

AI-assisted multi-domain lifestyle interventions that integrate dietary, physical activity, and psychological components.

AI assisted multi-domain lifestyle intervention

Tirzepatide DRUG

Administered subcutaneously.

Tirzepatide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Overweight; Obesity; Diabetes Mellitus, Type 2

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Central Study Contacts

Gang Liu, PHD

CONTACT

86-15926238366; liugang026@hust.edu.cn

Zijun Tang

CONTACT

86-13037181387; tangzj_2024@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 29, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)