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Overweight or Obesity; Type 2 DiabetesPhase 4NCT07555730

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

A Phase 4 study testing AI assisted multi-domain lifestyle intervention and Tirzepatide in people with Overweight or Obesity; Type 2 Diabetes and Weight Loss Maintenance, run by Huazhong University of Science and Technology at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
AI assisted multi-domain lifestyle intervention and Tirzepatide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteChina
Study dates
30 Apr 2026to 30 Sep 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 28Show fewer
  • 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;
  • 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
  • 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.
  • 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.
  • Female patients who are pregnant, lactating, or planning to become pregnant within the next two years.
  • 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.
  • Any other reasons that researchers deem to unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gang Liu, PHD contact

86-15926238366

liugang026@hust.edu.cn

Zijun Tang contact

86-13037181387

tangzj_2024@163.com

China1 site

  • Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

    Gang Liu, 86-15926238366, liugang026@hust.edu.cn

    Gang Liu

Other trials in China

About this study

Official title: 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.

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

Read the detailed description

Diabetes and obesity have emerged as critical public health problems in China. Notably, more than half of Chinese adults with diabetes are concurrently with overweight or obesity. Weight management is a cornerstone of type 2 diabetes treatment, with robust evidence showing that weight loss improves glycemic control, blood pressure, lipid profiles, and may facilitate diabetes remission. However, maintaining long-term weight loss remains a formidable clinical challenge. Current clinical guidelines recommend several maintenance strategies after achieving target weight loss, including continued use of anti-obesity medications (AOMs), dose reduction, or structured lifestyle interventions. Few studies have suggested that compared with continued tirzepatide treatment, switching to placebo resulted in significant weight regain. However, important knowledge gaps remain regarding the effectiveness of AI-assisted multi-domain lifestyle interventions that integrate dietary, physical activity, and psychological components compared with reduced dose of tirzepatide treatment on weight loss maintenance in patients with type 2 diabetes.

This study aims to investigate the effect of AI-assisted multi-domain lifestyle interventions on weight loss maintenance in overweight or obese patients with type 2 diabetes, compared with tirzepatide treatment.

Being tested
AI assisted multi-domain lifestyle intervention, Tirzepatide
Medical subject headings
Overweight, Obesity, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI assisted multi-domain lifestyle interventionBehavioural

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

  • TirzepatideDrug

    Administered subcutaneously.

Study groups in NCT07555730
Study groupRoleWhat they receive
AI assisted multi-domain lifestyle interventionExperimentalParticipants 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.
Receives: Behavioral: AI assisted multi-domain lifestyle intervention
TirzepatideActive comparatorParticipants will be randomized to receive tirzepatide 5 mg treatment for 52 weeks.
Receives: Drug: Tirzepatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body weight change (kg)

    Weight will be measured to the nearest 0.1 kg

    Measured: Change from randomization (week 20) to week 72

Secondary outcomes (18)

  1. Percent change in body weight

    Percent change from week 20 to week 72

    Measured: Change from randomization (week 20) to week 72

  2. Body mass index

    Weight / Height^2 (kg/m²)

    Measured: Change from randomization (week 20) to week 72

  3. Waist and hip circumference

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

    Measured: Change from randomization (week 20) to week 72

  4. Body fat percentage

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

    Measured: Change from randomization (week 20) to week 72

  5. Skeletal muscle mass

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

    Measured: Change from randomization (week 20) to week 72

  6. Fat mass

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

    Measured: Change from randomization (week 20) to week 72

  7. Fat free mass

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

    Measured: Change from randomization (week 20) to week 72

  8. Blood pressure

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

    Measured: Change from randomization (week 20) to week 72

  9. Concentration of glycated hemoglobin (HbA1c)

    Concentration of HbA1c, measured in the percentage of hemoglobin

    Measured: Change from randomization (week 20) to week 72

  10. Concentration of fasting glucose

    Concentration of fasting glucose, measured in mmol/L

    Measured: Change from randomization (week 20) to week 72

  11. Concentration of Insulin

    Concentration of fasting insulin, measured in mU/L

    Measured: Change from randomization (week 20) to week 72

  12. Concentration of C-peptide

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

    Measured: Change from randomization (week 20) to week 72

  13. Concentration of blood lipids

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

    Measured: Change from randomization (week 20) to week 72

  14. Body weight change (kg)

    Weight will be measured to the nearest 0.1 kg

    Measured: Change from baseline (week 0) to week 72

  15. Percent change in body weight

    • 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

    Measured: Change from baseline (week 0) to week 72

  16. Waist and hip circumference

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

    Measured: Change from baseline (week 0) to week 72

  17. Concentration of glycated hemoglobin (HbA1c)

    Concentration of HbA1c, measured in the percentage of hemoglobin.

    Measured: Change from baseline (week 0) to week 72

  18. Concentration of blood lipids

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

    Measured: Change from baseline (week 0) to week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2026
  2. Study start30 Apr 2026 (estimated)
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07555730
Sponsor's protocol ID
Lifestyle, Tirzepatide in T2D
Status last verified
Apr 2026
First submitted
15 Apr 2026
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing AI assisted multi-domain lifestyle intervention and Tirzepatide in people with Overweight or Obesity; Type 2 Diabetes and Weight Loss Maintenance, run by Huazhong University of Science and Technology at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gang Liu, PHD (86-15926238366, liugang026@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body weight change (kg) (time frame: Change from randomization (week 20) to week 72). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07555730.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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