AI vs. drug: can a smart lifestyle program replace Weight-Loss shots?
NCT ID NCT07555730
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether an AI-powered lifestyle program can help adults with type 2 diabetes maintain weight loss as well as continuing the drug tirzepatide. All 400 participants first take tirzepatide for 20 weeks to lose weight. Then, those who meet goals are randomly assigned to either the AI lifestyle support or continued tirzepatide for another 52 weeks. The main goal is to see which approach better prevents weight regain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tirzepatide
- What this could lead to
- If successful, this could show that an AI-guided lifestyle program is as effective as ongoing medication for keeping weight off in type 2 diabetes.
- What could go wrong
- This is a single trial with 400 participants, and results may not apply to everyone. The lifestyle intervention requires high commitment, and tirzepatide can cause side effects like nausea.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
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