Trial · Interventional
Not yet recruitingPhase 4Registry dataAI-Assisted Lifestyle Intervention Versus Tirzepatide for Obesity and Newly Diagnosed Type 2 Diabetes
Short name AI-LIFE-T2D-OB
Overview
- Status
- Not yet recruiting
- Phase
- Phase 4
- Enrollment
- 285 participants (estimated)
- Sponsor
- The First Affiliated Hospital of Anhui Medical University · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
China
- Start
- 20 Jul 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Completion
- 31 Jan 2028 (estimated)
- First posted
- 13 Jul 2026
- Last update posted
- 13 Jul 2026
- Conditions
- Obesity · Diabetes Mellitus, Type 2
Timeline
1 trial · 1 not yet recruiting
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- AI-Assisted Intensive Lifestyle InterventionBehavioral
- TirzepatideDrug
- Standard Lifestyle ManagementBehavioral
Arms3
Experimental
AI-Assisted Intensive Lifestyle Intervention
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.
Active comparator
Tirzepatide Treatment
Participants in this arm will receive tirzepatide treatment according to the study protocol, in addition to standardized lifestyle education.
Active comparator
Standard Lifestyle Management
Participants in this arm will receive standardized lifestyle management and health education according to the study protocol.
Primary outcomes1
Outcomes the sponsor listed as primary.
Percent Change in Body Weight From Baseline to Week 52
Time frame · Baseline to Week 52
Registry description
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.
Secondary outcomes(11)
Change in HbA1c From Baseline to Week 52
Time frame · Baseline to Week 52
Registry description
Change in glycated hemoglobin from baseline to week 52.
Change in Fasting Plasma Glucose From Baseline to Week 52
Time frame · Baseline to Week 52
Registry description
Change in fasting plasma glucose from baseline to week 52.
Change in Waist Circumference From Baseline to Week 52
Time frame · Baseline to Week 52
Registry description
Change in waist circumference from baseline to week 52.
Change in Body Mass Index From Baseline to Week 52
Time frame · Baseline to Week 52
Registry description
Change in body mass index from baseline to week 52.
Proportion of Participants Achieving Type 2 Diabetes Remission at Week 64
Time frame · Week 64
Registry description
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.
Change in CGM Time in Range From Baseline to Week 52
Time frame · Baseline to Week 52
Registry description
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.
Change in CGM Time Above Range From Baseline to Week 52
Time frame · Baseline to Week 52
Registry description
Change in the percentage of continuous glucose monitoring time with glucose values above 10.0 mmol/L from baseline to week 52.
Change in CGM Time Below Range From Baseline to Week 52
Time frame · Baseline to Week 52
Registry description
Change in the percentage of continuous glucose monitoring time with glucose values below 3.9 mmol/L from baseline to week 52.
Change in CGM Coefficient of Variation From Baseline to Week 52
Time frame · Baseline to Week 52
Registry description
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.
Incidence of Adverse Events
Time frame · From enrollment to Week 64
Registry description
The proportion of participants who experience at least one adverse event during the study period.
Incidence of Serious Adverse Events
Time frame · From enrollment to Week 64
Registry description
The proportion of participants who experience at least one serious adverse event during the study period.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 65 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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