ObesityPhase 4AI-LIFE-T2D-OBNCT07697391
AI-Assisted Lifestyle Intervention Versus Tirzepatide for Obesity and Newly Diagnosed Type 2 Diabetes
A Phase 4 study testing AI-Assisted Intensive Lifestyle Intervention, Tirzepatide and Standard Lifestyle Management in people with Obesity and Diabetes Mellitus, Type 2, run by The First Affiliated Hospital of Anhui Medical University at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2
- What is being tested?
- AI-Assisted Intensive Lifestyle Intervention, Tirzepatide and Standard Lifestyle Management
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 5 sitesChina
- Study dates
- 16 Jul 2026to 31 Jan 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.
- 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.
Who cannot join
- 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.
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- 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.
- Blood dyscrasia or any disease causing hemolysis or unstable red blood cells, or hemoglobinopathy that may affect HbA1c measurement.
- History of organ transplantation or acquired or congenital immune system disease.
- Schizophrenia or other psychiatric disorder that may interfere with participation in the study.
- Unstable or treatment-requiring endocrine disease related to glycemic control, such as hyperthyroidism, acromegaly, or Cushing syndrome, as judged by the investigator.
- Hypertension with systolic blood pressure >150 mmHg and/or diastolic blood pressure >90 mmHg after stable antihypertensive treatment.
- Clinically significant abnormal gastric emptying, severe chronic gastrointestinal disease, diabetic gastroparesis, long-term use of medications directly affecting gastrointestinal motility, or history of gastrointestinal surgery.
- Special dietary requirements or allergy to foods such as soy products or dairy products.
- Use of medications affecting glucose regulation within 3 months before randomization, such as glucocorticoids, growth hormone, thyroid hormone, sex hormones, cyclosporine, or phenytoin.
- Allergic constitution, defined as allergy to two or more categories of substances.
- Fasting C-peptide <0.81 ng/mL.
- Calcitonin ≥50 pg/mL.
- Abnormal laboratory results, including AST or ALT >2.5 × upper limit of normal, bilirubin >2.5 × upper limit of normal, triglycerides ≥5.7 mmol/L, estimated creatinine clearance <60 mL/min using the Cockcroft-Gault formula, or clinically significant anemia with hemoglobin <120 g/L in men or <110 g/L in women.
- Unstable proliferative retinopathy or maculopathy requiring urgent treatment within 1 year before randomization, or history of diabetic ketoacidosis, hyperosmolar nonketotic coma, or severe metabolic disorder causing neuropsychiatric dysfunction.
- History or risk factors of epilepsy, syncope, cardiac arrest, arrhythmia, atrioventricular block, structural heart disease, torsades de pointes, hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, or hypocalcemia.
- Active bacterial, viral, or fungal infection requiring hospitalization or intravenous antibiotic treatment.
- Positive HBsAg, HCV antibody, HIV antibody, or Treponema pallidum antibody.
- Positive urine drug screening and/or drug dependence.
- Participation in another clinical trial within 3 months before enrollment or current participation in another drug or device clinical trial.
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for this study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016
Meiwen He, +8619966188536, hemeiwen0128@163.com
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Meiwen He, +8619966188536, hemeiwen0128@163.com
- Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
Meiwen He, +8619966188536, hemeiwen0128@163.com
- Recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Meiwen He, +8619966188536, hemeiwen0128@163.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Meiwen He, +8619966188536, hemeiwen0128@163.com
About this study
Official title: A Multicenter Randomized Controlled Trial Evaluating AI-Assisted Intensive Lifestyle Intervention Versus Tirzepatide for Glycemic and Weight Management in Patients With Obesity and Newly Diagnosed Type 2 Diabetes
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.
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Being tested
- AI-Assisted Intensive Lifestyle Intervention, Tirzepatide, Standard Lifestyle Management
- Keywords
- AI-Assisted Lifestyle Intervention, Tirzepatide, Weight Management, Glycemic Control, Continuous Glucose Monitoring, Randomized Controlled Trial
- Medical subject headings
- 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 Intensive Lifestyle InterventionBehavioural
An intensive lifestyle intervention supported by an AI-based platform and nutritionist follow-up, including individualized dietary guidance, lifestyle behavior support, and weight management counseling.
TirzepatideDrug
Tirzepatide will be administered by subcutaneous injection once weekly according to the protocol-defined dose titration and tolerability assessment.
Standard Lifestyle ManagementBehavioural
Standardized lifestyle management and health education, including general dietary, physical activity, and weight management advice according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| AI-Assisted Intensive Lifestyle Intervention | Experimental | Participants in this arm will receive an AI-assisted intensive lifestyle intervention, including individualized dietary and lifestyle guidance supported by an AI-based platform and nutritionist follow-up, in addition to standardized lifestyle education. Receives: Behavioral: AI-Assisted Intensive Lifestyle Intervention; Behavioral: Standard Lifestyle Management |
| Tirzepatide Treatment | Active comparator | Participants in this arm will receive tirzepatide treatment according to the study protocol, in addition to standardized lifestyle education. Receives: Drug: Tirzepatide; Behavioral: Standard Lifestyle Management |
| Standard Lifestyle Management | Active comparator | Participants in this arm will receive standardized lifestyle management and health education according to the study protocol. Receives: Behavioral: Standard Lifestyle Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Body Weight From Baseline to Week 52
Percent change in body weight from baseline to week 52 will be calculated as [(body weight at week 52 - body weight at baseline) / body weight at baseline] × 100%. A negative value indicates weight loss.
Measured: Baseline to Week 52
Secondary outcomes (11)
Change in HbA1c From Baseline to Week 52
Change in glycated hemoglobin from baseline to week 52.
Measured: Baseline to Week 52
Change in Fasting Plasma Glucose From Baseline to Week 52
Change in fasting plasma glucose from baseline to week 52.
Measured: Baseline to Week 52
Change in Waist Circumference From Baseline to Week 52
Change in waist circumference from baseline to week 52.
Measured: Baseline to Week 52
Change in Body Mass Index From Baseline to Week 52
Change in body mass index from baseline to week 52.
Measured: Baseline to Week 52
Proportion of Participants Achieving Type 2 Diabetes Remission at Week 64
Type 2 diabetes remission is defined as HbA1c <6.5% at week 64 without the use of glucose-lowering medications for at least 3 months before the assessment. Participants who receive rescue glucose-lowering therapy before week 64 will be considered not achieving remission.
Measured: Week 64
Change in CGM Time in Range From Baseline to Week 52
Change in the percentage of continuous glucose monitoring time with glucose values between 3.9 and 10.0 mmol/L from baseline to week 52.
Measured: Baseline to Week 52
Change in CGM Time Above Range From Baseline to Week 52
Change in the percentage of continuous glucose monitoring time with glucose values above 10.0 mmol/L from baseline to week 52.
Measured: Baseline to Week 52
Change in CGM Time Below Range From Baseline to Week 52
Change in the percentage of continuous glucose monitoring time with glucose values below 3.9 mmol/L from baseline to week 52.
Measured: Baseline to Week 52
Change in CGM Coefficient of Variation From Baseline to Week 52
Change in the coefficient of variation of continuous glucose monitoring glucose values from baseline to week 52. The coefficient of variation will be expressed as a percentage.
Measured: Baseline to Week 52
Incidence of Adverse Events
The proportion of participants who experience at least one adverse event during the study period.
Measured: From enrollment to Week 64
Incidence of Serious Adverse Events
The proportion of participants who experience at least one serious adverse event during the study period.
Measured: From enrollment to Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start16 Jul 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Participants will be randomized in a 2:2:1 ratio to an AI-assisted intensive lifestyle intervention group, a tirzepatide treatment group, or a standard lifestyle management control group.
- Masking
- None (open label)
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Nutriease Health Technology Co. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697391
- Sponsor's protocol ID
- FAH-AMU-OBT2D-001
- Other IDs
- MR-34-26-044995
- Acronym
- AI-LIFE-T2D-OB
- Status last verified
- Nov 2026
- First submitted
- 6 Jul 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of participant privacy protection, ethical restrictions, and institutional data governance requirements.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial Evaluating AI-Assisted Intensive Lifestyle Intervention Versus Tirzepatide for Glycemic and Weight Management in Patients With Obesity and Newly Diagnosed Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07697391
- Acronym / sponsor ID
- AI-LIFE-T2D-OB / FAH-AMU-OBT2D-001
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Keywords
- AI-Assisted Lifestyle Intervention, Tirzepatide, Weight Management, Glycemic Control, Continuous Glucose Monitoring, Randomized Controlled Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Collaborators
- Zhejiang Nutriease Health Technology Co. Ltd.
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomized in a 2:2:1 ratio to an AI-assisted intensive lifestyle intervention group, a tirzepatide treatment group, or a standard lifestyle management control group.
| Arm | Type | Receives |
|---|---|---|
| AI-Assisted Intensive Lifestyle Intervention | Experimental | Behavioral: AI-Assisted Intensive Lifestyle Intervention, Behavioral: Standard Lifestyle ManagementParticipants in this arm will receive an AI-assisted intensive lifestyle intervention, including individualized dietary and lifestyle guidance supported by an AI-based platform and nutritionist follow-up, in addition to standardized lifestyle education. |
| Tirzepatide Treatment | Active comparator | Drug: Tirzepatide, Behavioral: Standard Lifestyle ManagementParticipants in this arm will receive tirzepatide treatment according to the study protocol, in addition to standardized lifestyle education. |
| Standard Lifestyle Management | Active comparator | Behavioral: Standard Lifestyle ManagementParticipants in this arm will receive standardized lifestyle management and health education according to the study protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Assisted Intensive Lifestyle InterventionAn intensive lifestyle intervention supported by an AI-based platform and nutritionist follow-up, including individualized dietary guidance, lifestyle behavior support, and weight management counseling. | Behavioural | AI-Assisted Intensive Lifestyle Intervention |
| TirzepatideTirzepatide will be administered by subcutaneous injection once weekly according to the protocol-defined dose titration and tolerability assessment. | Drug | Tirzepatide Treatment |
| Standard Lifestyle ManagementStandardized lifestyle management and health education, including general dietary, physical activity, and weight management advice according to the study protocol. | Behavioural | AI-Assisted Intensive Lifestyle Intervention, Standard Lifestyle Management, Tirzepatide Treatment |
Primary outcome
Percent Change in Body Weight From Baseline to Week 52
Time frame: Baseline to Week 52
Percent change in body weight from baseline to week 52 will be calculated as [(body weight at week 52 - body weight at baseline) / body weight at baseline] × 100%. A negative value indicates weight loss.
11 secondary outcomes
Change in HbA1c From Baseline to Week 52
Time frame: Baseline to Week 52
Change in Fasting Plasma Glucose From Baseline to Week 52
Time frame: Baseline to Week 52
Change in Waist Circumference From Baseline to Week 52
Time frame: Baseline to Week 52
Change in Body Mass Index From Baseline to Week 52
Time frame: Baseline to Week 52
Proportion of Participants Achieving Type 2 Diabetes Remission at Week 64
Time frame: Week 64
Change in CGM Time in Range From Baseline to Week 52
Time frame: Baseline to Week 52
Change in CGM Time Above Range From Baseline to Week 52
Time frame: Baseline to Week 52
Change in CGM Time Below Range From Baseline to Week 52
Time frame: Baseline to Week 52
Change in CGM Coefficient of Variation From Baseline to Week 52
Time frame: Baseline to Week 52
Incidence of Adverse Events
Time frame: From enrollment to Week 64
Incidence of Serious Adverse Events
Time frame: From enrollment to Week 64
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of participant privacy protection, ethical restrictions, and institutional data governance requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AI-Assisted Intensive Lifestyle Intervention, Tirzepatide and Standard Lifestyle Management in people with Obesity and Diabetes Mellitus, Type 2, run by The First Affiliated Hospital of Anhui Medical University at 5 sites 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 5 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Xueying Zheng (+8619966188536, lisazhengxy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Body Weight From Baseline to Week 52 (time frame: Baseline to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.