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Not yet recruitingPhase 4

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.

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

NCT IDNCT07555730
Org study IDLifestyle, Tirzepatide in T2D

Timeline

Milestones

Study first posted2026-04-29actual
Last update posted2026-04-29actual
Study start2026-04-30estimated
Primary completion2028-09-30estimated
Study completion2028-09-30estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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.

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
Glycemic / diabetes
7
Cardiometabolic biomarkers
4
MASH / liver
3
Renal / kidney
3
Other (unclassified)
2
Safety / tolerability / PK
1

Weight & body composition

12 endpoints
Primary/protocol endpoint

Body weight change (kg)

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

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percent change in body weight

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

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Body mass index

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

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Waist and hip circumference

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

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Body fat percentage

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

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Skeletal muscle mass

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

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Fat mass

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

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Fat free mass

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

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Body weight change (kg)

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

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percent change in body weight

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

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Waist and hip circumference

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

Waist circumference, change

change from baseline, improvement

Other/protocol endpoint

Visceral fat

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

Visceral fat, change

change from baseline, improvement

Glycemic / diabetes

7 endpoints
Secondary/protocol endpoint

Concentration of glycated hemoglobin (HbA1c)

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Concentration of fasting glucose

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

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Concentration of Insulin

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

change from baseline, improvement

Secondary/protocol endpoint

Concentration of C-peptide

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

C-peptide AUC

change from baseline, improvement

Secondary/protocol endpoint

Concentration of glycated hemoglobin (HbA1c)

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Other/protocol endpoint

HOMA-IR

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

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other/protocol endpoint/low confidence

HOMA-β

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

change from baseline, improvement

MASH / liver

3 endpoints
Other/protocol endpoint

Liver stiffness measurement

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

Liver stiffness (VCTE), change

change from baseline, improvement

Other/protocol endpoint

Controlled attenuation parameter

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

change from baseline, improvement

Other/protocol endpoint

Liver function

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

change from baseline, improvement

Renal / kidney

3 endpoints
Other/protocol endpoint

Concentration of serum creatinine

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

concentration, descriptive

Other/protocol endpoint

Concentration of serum Cystatin C

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

concentration, descriptive

Other/protocol endpoint

Estimated glomerular filtration rate

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

eGFR, change

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Blood pressure

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

change from baseline, improvement

Secondary/protocol endpoint

Concentration of blood lipids

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

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Concentration of blood lipids

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

change from baseline, improvement

Other/protocol endpoint

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 endpoint
Other/protocol endpoint

Number of adverse events

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

Treatment-emergent AEs (any)

event count, event

Other (unclassified)

2 endpoints
Other/protocol endpoint/low confidence

Metagenomic analysis of the gut microbiota

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

descriptive

Other/protocol endpoint/low confidence

Concentration of serum uric

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

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.