AI-Assisted Lifestyle Intervention Versus Tirzepatide for Obesity and Newly Diagnosed Type 2 Diab… (NCT07697391) | Clinical Trial Compass
Not Yet RecruitingPhase 4
AI-Assisted Lifestyle Intervention Versus Tirzepatide for Obesity and Newly Diagnosed Type 2 Diabetes
China285 participantsStarted 2026-07-20
Plain-language summary
This multicenter randomized controlled trial will evaluate whether an AI-assisted intensive lifestyle intervention can improve weight and glycemic management in adults with obesity and newly diagnosed type 2 diabetes, compared with tirzepatide treatment and standard lifestyle management. Eligible participants will be adults aged 18 to 65 years with a body mass index of 28 to less than 40 kg/m² and newly diagnosed type 2 diabetes who have not used glucose-lowering medications in the past 3 months.
Participants will be randomly assigned to one of three groups: an AI-assisted intensive lifestyle intervention group, a tirzepatide treatment group, or a standard lifestyle management control group. The intervention period will last 52 weeks, followed by a 12-week post-intervention follow-up period. The main outcome is the percentage change in body weight at week 52. The study will also assess glycemic control, body composition, continuous glucose monitoring metrics, safety, and other metabolic outcomes.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female participants aged 18 to 65 years.
. Newly diagnosed type 2 diabetes mellitus, defined as diagnosis within 3 years and no use of glucose-lowering medications within the past 3 months. Diagnosis should meet the 1999 World Health Organization criteria, including at least one of the following: random plasma glucose ≥11.1 mmol/L, fasting blood glucose ≥7.0 mmol/L, 2-hour postprandial blood glucose ≥11.1 mmol/L, or HbA1c ≥6.5% and ≤10.0%. Participants without typical diabetes symptoms should have repeat testing for confirmation.
. Body mass index ≥28 kg/m² and \<40 kg/m².
. Willing to use effective contraception and have no pregnancy plan within 12 months after signing the informed consent form; female participants must have a negative pregnancy test at screening.
. Able to communicate with the investigators, willing to comply with the study protocol, and voluntarily sign the informed consent form.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares an AI-assisted lifestyle program against tirzepatide — since tirzepatide is already FDA-approved for obesity and type 2 diabetes, would my doctor think I'd be giving up a proven treatment option by joining a study where I might be assigned to the lifestyle arm instead?
2The trial isn't recruiting yet — how long does my doctor think it might be before it opens, and is waiting a realistic option given that I've just been diagnosed with type 2 diabetes and may need to start managing my blood sugar sooner?
3Since this is a Phase 4 trial, does my doctor think the safety profile of tirzepatide is well enough established that the main question here is really about how it compares to an AI-guided lifestyle approach, rather than whether tirzepatide itself is safe?
4The primary outcome is measured at 52 weeks, meaning I'd be committing to at least a year of participation — what does my doctor think that would involve in terms of visits, monitoring, and the demands of following either an AI-based program or a medication regimen over that time?
5If I'm newly diagnosed, does my doctor think there's a reason to consider this trial over starting standard care right away, or would it make more sense to try an established treatment first and revisit research options later?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change in Body Weight From Baseline to Week 52
Timeframe: Baseline to Week 52
Trial details
NCT IDNCT07697391
SponsorThe First Affiliated Hospital of Anhui Medical University
. Type 1 diabetes mellitus, type 2 diabetes requiring insulin treatment, or other specific types of diabetes.
. Body weight change \>5% within 12 weeks before screening.
. Pregnant or breastfeeding women.
. Severe trauma, severe infection, or surgery within 1 month before screening that may affect glycemic control.
. Severe cardiovascular or cerebrovascular events within 6 months before screening, including angina, myocardial infarction, arrhythmia, cerebral infarction, cerebral hemorrhage, or other clinically significant events.
. History of acute or chronic pancreatitis, history of pancreatic injury, or amylase \>1.5 × upper limit of normal at screening.
. Current or previous malignancy, except local basal cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the prostate; diagnosis of malignancy within 5 years before screening.
. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, or history of thyroid nodules.