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Trial · Interventional

Not yet recruitingPhase 4Registry data

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

NCTNCT07555730 (opens ClinicalTrials.gov in a new tab)Other idLifestyle, Tirzepatide in T2D

Overview

Status
Not yet recruiting
Phase
Phase 4
Enrollment
400 participants (estimated)
Sponsor
Huazhong University of Science and Technology · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
30 Apr 2026 (estimated)
Primary completion
30 Sept 2028 (estimated)
Completion
30 Sept 2028 (estimated)
First posted
29 Apr 2026
Last update posted
29 Apr 2026
Conditions
Overweight or Obesity; Type 2 Diabetes · Weight Loss Maintenance

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029
  1. Ph 4

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

    NCT07555730

    est. 30 Apr 2026 to est. 30 Sept 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • AI assisted multi-domain lifestyle interventionBehavioral
  • TirzepatideDrug

Arms2

  • Experimental

    AI assisted multi-domain lifestyle intervention

    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.

  • Active comparator

    Tirzepatide

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Body weight change (kg)

    Time frame · Change from randomization (week 20) to week 72

    Registry description

    Weight will be measured to the nearest 0.1 kg

Secondary outcomes(18)
  1. Percent change in body weight

    Time frame · Change from randomization (week 20) to week 72

    Registry description

    Percent change from week 20 to week 72

  2. Body mass index

    Time frame · Change from randomization (week 20) to week 72

    Registry description

    Weight / Height\^2 (kg/m²)

  3. Waist and hip circumference

    Time frame · Change from randomization (week 20) to week 72

    Registry description

    Waist and hip circumference will be measured to the nearest 0.1cm

  4. Body fat percentage

    Time frame · Change from randomization (week 20) to week 72

    Registry description

    Change in body fat percentage (BF%) from randomization to the week 72

  5. Skeletal muscle mass

    Time frame · Change from randomization (week 20) to week 72

    Registry description

    Change in skeletal muscle mass (SMM) from randomization to the week 72, measured in kg

  6. Fat mass

    Time frame · Change from randomization (week 20) to week 72

    Registry description

    Change in fat mass (FM) from randomization to the week 72, measured in kg

  7. Fat free mass

    Time frame · Change from randomization (week 20) to week 72

    Registry description

    Change in fat free mass (FFM) from randomization to the week 72, measured in kg

  8. Blood pressure

    Time frame · Change from randomization (week 20) to week 72

    Registry description

    Blood pressure (systolic/diastolic) will be measured with a digital blood pressure monitor in sitting position (mmHg)

  9. Concentration of glycated hemoglobin (HbA1c)

    Time frame · Change from randomization (week 20) to week 72

    Registry description

    Concentration of HbA1c, measured in the percentage of hemoglobin

  10. Concentration of fasting glucose

    Time frame · Change from randomization (week 20) to week 72

    Registry description

    Concentration of fasting glucose, measured in mmol/L

  11. Concentration of Insulin

    Time frame · Change from randomization (week 20) to week 72

    Registry description

    Concentration of fasting insulin, measured in mU/L

  12. Concentration of C-peptide

    Time frame · Change from randomization (week 20) to week 72

    Registry description

    Concentration of fasting C-peptide, measured in mmol/L

  13. Concentration of blood lipids

    Time frame · Change from randomization (week 20) to week 72

    Registry description

    Concentration of blood lipids (total cholesterol, triglycerides, low-density lipoprotein cholesterol, high density lipoprotein cholesterol), measured in mmol/L

  14. Body weight change (kg)

    Time frame · Change from baseline (week 0) to week 72

    Registry description

    Weight will be measured to the nearest 0.1 kg

  15. Percent change in body weight

    Time frame · Change from baseline (week 0) to week 72

    Registry description

    * Percent change from week 0 to week 72 * Percentage of participants who achieve ≥5% body weight reduction * Percentage of participants who achieve ≥10% body weight reduction * Percentage of participants who achieve ≥15% body weight reduction

  16. Waist and hip circumference

    Time frame · Change from baseline (week 0) to week 72

    Registry description

    Waist and hip circumference will be measured to the nearest 0.1cm

  17. Concentration of glycated hemoglobin (HbA1c)

    Time frame · Change from baseline (week 0) to week 72

    Registry description

    Concentration of HbA1c, measured in the percentage of hemoglobin.

  18. Concentration of blood lipids

    Time frame · Change from baseline (week 0) to week 72

    Registry description

    Concentration of blood lipids (total cholesterol, triglycerides, low-density lipoprotein cholesterol, high density lipoprotein cholesterol), measured in mmol/L

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Male or female participants aged 18 to 65 years at the time of signing informed consent; 2. Body Mass Index (BMI) ≥27.0 kg/m²; 3. Type 2 diabetes mellitus diagnosed by physicians within the past 5 years prior to screening. 4. Voluntary participation and provide written informed consent. Exclusion Criteria: 1. History of type 1 diabetes mellitus or other types of diabetes, or treatment with insulin. 2. History of obesity attributable to endocrine disorders or monogenic mutations. 3. A self-reported change in body weight ≥5.0% within 3 months prior to the day of screening. 4. Use of medications or products causing weight changes or affecting weight assessment within 3 months prior to the day of screening; 5. History of major adverse cardiovascular or cerebrovascular events within 6 months before screening (e.g., angina, myocardial infarction, arrhythmia, stroke, intracranial hemorrhage). 6. History of acute or chronic pancreatitis, pancreatic injury, or other high-risk factors for pancreatitis. 7. 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). 8. History of organ transplantation, congenital or acquired immunodeficiency disorders. 9. History of schizophrenia or major depressive disorder or other severe psychiatric disorders. 10. 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). 11. 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. 12. 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. 13. 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 14. 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. 15. 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). 16. Patients with active bacterial, viral, or fungal infections requiring hospitalization or antibiotic treatment. 17. History of infectious diseases such as human immunodeficiency virus (HIV), syphilis, or active hepatitis. 18. Female patients who are pregnant, lactating, or planning to become pregnant within the next two years. 19. Participation in other clinical trial within 3 months before screening or currently enrolled in other clinical trial study. 20. History of drug abuse or alcohol dependence within 6 months before screening. 21. Any other reasons that researchers deem to unsuitable for participation in this study.

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