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AI-assisted Multi-domain Lifestyle Versus Tirzepatide for Weight Loss Maintenance in Adults With Type 2 Diabetes (AIM-MAINTAIN)
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.
Lead sponsor
Asset
Tirzepatide
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
400
estimated
Study population
Obesity / overweight, Type 2 diabetes
Key I/E criterion
•BMI ≥27
Primary endpoint
•Body weight, absolute change (kg)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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:
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.
Endpoints (32)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
12 endpointsBody weight change (kg)
Time frame:Change from randomization (week 20) to week 72
Body weight, absolute change (kg)
change from baseline, improvement
Percent change in body weight
Time frame:Change from randomization (week 20) to week 72
Body weight, % change
percent change from baseline, improvement
Body mass index
Time frame:Change from randomization (week 20) to week 72
BMI, change
change from baseline, improvement
Waist and hip circumference
Time frame:Change from randomization (week 20) to week 72
Waist circumference, change
change from baseline, improvement
Body fat percentage
Time frame:Change from randomization (week 20) to week 72
Total fat mass
change from baseline, improvement
Skeletal muscle mass
Time frame:Change from randomization (week 20) to week 72
Lean mass
change from baseline, improvement
Fat mass
Time frame:Change from randomization (week 20) to week 72
Total fat mass
change from baseline, improvement
Fat free mass
Time frame:Change from randomization (week 20) to week 72
Lean mass
change from baseline, improvement
Body weight change (kg)
Time frame:Change from baseline (week 0) to week 72
Body weight, absolute change (kg)
change from baseline, improvement
Percent change in body weight
Time frame:Change from baseline (week 0) to week 72
Body weight, % change
percent change from baseline, improvement
Waist and hip circumference
Time frame:Change from baseline (week 0) to week 72
Waist circumference, change
change from baseline, improvement
Visceral fat
Time frame:Change from baseline (week 0) to week 72
Visceral fat, change
change from baseline, improvement
Glycemic / diabetes
7 endpointsConcentration of glycated hemoglobin (HbA1c)
Time frame:Change from randomization (week 20) to week 72
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Concentration of fasting glucose
Time frame:Change from randomization (week 20) to week 72
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Concentration of Insulin
Time frame:Change from randomization (week 20) to week 72
change from baseline, improvement
Concentration of C-peptide
Time frame:Change from randomization (week 20) to week 72
C-peptide AUC
change from baseline, improvement
Concentration of glycated hemoglobin (HbA1c)
Time frame:Change from baseline (week 0) to week 72
HbA1c, change
change from baseline, improvement
LOINC 4548-4
HOMA-IR
Time frame:Change from baseline (week 0) to week 72
HOMA-IR (insulin sensitivity)
change from baseline, improvement
HOMA-β
Time frame:Change from baseline (week 0) to week 72
change from baseline, improvement
MASH / liver
3 endpointsLiver stiffness measurement
Time frame:Change from baseline (week 0) to week 72
Liver stiffness (VCTE), change
change from baseline, improvement
Controlled attenuation parameter
Time frame:Change from baseline (week 0) to week 72
change from baseline, improvement
Liver function
Time frame:Change from baseline (week 0) to week 72
change from baseline, improvement
Renal / kidney
3 endpointsConcentration of serum creatinine
Time frame:Change from baseline (week 0) to week 72
concentration, descriptive
Concentration of serum Cystatin C
Time frame:Change from baseline (week 0) to week 72
concentration, descriptive
Estimated glomerular filtration rate
Time frame:Change from baseline (week 0) to week 72
eGFR, change
change from baseline, improvement
Cardiometabolic biomarkers
4 endpointsBlood pressure
Time frame:Change from randomization (week 20) to week 72
change from baseline, improvement
Concentration of blood lipids
Time frame:Change from randomization (week 20) to week 72
change from baseline, improvement
Concentration of blood lipids
Time frame:Change from baseline (week 0) to week 72
change from baseline, improvement
Concentration of high-sensitivity C-reactive protein (hs-CRP)
Time frame:Change from baseline (week 0) to week 72
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Safety / tolerability / PK
1 endpointNumber of adverse events
Time frame:Change from baseline (week 0) to week 72
Treatment-emergent AEs (any)
event count, event
Other (unclassified)
2 endpointsMetagenomic analysis of the gut microbiota
Time frame:Change from baseline (week 0) to week 72
descriptive
Concentration of serum uric
Time frame:Change from baseline (week 0) to week 72
change from baseline, descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.