Trial · Interventional
Not yet recruitingPhase 4Registry dataAI-assisted Multi-domain Lifestyle Versus Tirzepatide for Weight Loss Maintenance in Adults With Type 2 Diabetes (AIM-MAINTAIN)
Overview
- Status
- Not yet recruiting
- Phase
- Phase 4
- Enrollment
- 400 participants (estimated)
- Sponsor
- Huazhong University of Science and Technology · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
China
- Start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Sept 2028 (estimated)
- Completion
- 30 Sept 2028 (estimated)
- First posted
- 29 Apr 2026
- Last update posted
- 29 Apr 2026
- Conditions
- Overweight or Obesity; Type 2 Diabetes · Weight Loss Maintenance
Timeline
1 trial · 1 not yet recruiting
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
AI-assisted Multi-domain Lifestyle Versus Tirzepatide for Weight Loss Maintenance in Adults With Type 2 Diabetes (AIM-MAINTAIN)
NCT07555730est. 30 Apr 2026 to est. 30 Sept 2028
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
Interventions
- AI assisted multi-domain lifestyle interventionBehavioral
- TirzepatideDrug
Arms2
Experimental
AI assisted multi-domain lifestyle intervention
Participants 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.
Active comparator
Tirzepatide
Participants will be randomized to receive tirzepatide 5 mg treatment for 52 weeks.
Primary outcomes1
Outcomes the sponsor listed as primary.
Body weight change (kg)
Time frame · Change from randomization (week 20) to week 72
Registry description
Weight will be measured to the nearest 0.1 kg
Secondary outcomes(18)
Percent change in body weight
Time frame · Change from randomization (week 20) to week 72
Registry description
Percent change from week 20 to week 72
Body mass index
Time frame · Change from randomization (week 20) to week 72
Registry description
Weight / Height\^2 (kg/m²)
Waist and hip circumference
Time frame · Change from randomization (week 20) to week 72
Registry description
Waist and hip circumference will be measured to the nearest 0.1cm
Body fat percentage
Time frame · Change from randomization (week 20) to week 72
Registry description
Change in body fat percentage (BF%) from randomization to the week 72
Skeletal muscle mass
Time frame · Change from randomization (week 20) to week 72
Registry description
Change in skeletal muscle mass (SMM) from randomization to the week 72, measured in kg
Fat mass
Time frame · Change from randomization (week 20) to week 72
Registry description
Change in fat mass (FM) from randomization to the week 72, measured in kg
Fat free mass
Time frame · Change from randomization (week 20) to week 72
Registry description
Change in fat free mass (FFM) from randomization to the week 72, measured in kg
Blood pressure
Time frame · Change from randomization (week 20) to week 72
Registry description
Blood pressure (systolic/diastolic) will be measured with a digital blood pressure monitor in sitting position (mmHg)
Concentration of glycated hemoglobin (HbA1c)
Time frame · Change from randomization (week 20) to week 72
Registry description
Concentration of HbA1c, measured in the percentage of hemoglobin
Concentration of fasting glucose
Time frame · Change from randomization (week 20) to week 72
Registry description
Concentration of fasting glucose, measured in mmol/L
Concentration of Insulin
Time frame · Change from randomization (week 20) to week 72
Registry description
Concentration of fasting insulin, measured in mU/L
Concentration of C-peptide
Time frame · Change from randomization (week 20) to week 72
Registry description
Concentration of fasting C-peptide, measured in mmol/L
Concentration of blood lipids
Time frame · Change from randomization (week 20) to week 72
Registry description
Concentration of blood lipids (total cholesterol, triglycerides, low-density lipoprotein cholesterol, high density lipoprotein cholesterol), measured in mmol/L
Body weight change (kg)
Time frame · Change from baseline (week 0) to week 72
Registry description
Weight will be measured to the nearest 0.1 kg
Percent change in body weight
Time frame · Change from baseline (week 0) to week 72
Registry description
* 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
Waist and hip circumference
Time frame · Change from baseline (week 0) to week 72
Registry description
Waist and hip circumference will be measured to the nearest 0.1cm
Concentration of glycated hemoglobin (HbA1c)
Time frame · Change from baseline (week 0) to week 72
Registry description
Concentration of HbA1c, measured in the percentage of hemoglobin.
Concentration of blood lipids
Time frame · Change from baseline (week 0) to week 72
Registry description
Concentration of blood lipids (total cholesterol, triglycerides, low-density lipoprotein cholesterol, high density lipoprotein cholesterol), measured in mmol/L
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
PepBank is a research reference. Talk to a doctor before you use any peptide.