Adults With Simple Obesity
Conditions
Brief summary
This study is a prospective, randomized, open-label clinical trial enrolling 66 adults with simple obesity who have not used weight-loss medications for at least 3 months. Participants will receive semaglutide, tirzepatide, or metformin for 24 weeks. Changes in biological (epigenetic) age will be assessed using the iWatchAge DNA methylation age test, while simultaneously monitoring improvements in aging-related biomarkers such as inflammatory factors, metabolic parameters, and body composition. The aim is to determine whether incretin-based therapies can reverse or slow obesity-related accelerated epigenetic aging and to provide new clinical evidence for interventions targeting obesity and aging.
Interventions
DRUGSemaglutide
Semaglutide administered once weekly by subcutaneous injection.Dose titrated from 0.25 mg to 2.0 mg as tolerated over 24 weeks
DRUGTirzepatide
Tirzepatide administered once weekly by subcutaneous injection. Dose titrated from 2.5 mg to 10 mg as tolerated over 24 weeks
DRUGMetformin
Metformin administered orally. Dose titrated from 500 mg to 1500-2000 mg daily, based on tolerance, for 24 weeks
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 to 75 years. 2. Diagnosed with simple obesity, defined as BMI ≥ 30 kg/m². 3. Have not used any anti-obesity medications (including GLP-1 RAs, tirzepatide, metformin for weight loss, etc.) within the past 3 months. 4. Able and willing to comply with study procedures and complete follow-up assessments. 5. Provide written informed consent.
Exclusion criteria
1. Presence of secondary obesity (e.g., endocrine disorders such as Cushing's syndrome or hypothyroidism). 2. Use of anti-obesity medications or participation in another weight-loss program within the past 3 months. 3. Diagnosed type 1 or type 2 diabetes mellitus requiring hypoglycemic drug therapy. 4. History of pancreatitis, severe gastrointestinal disease, or bariatric surgery. 5. Severe cardiovascular, hepatic, renal, or psychiatric disease that may affect participation. 6. Pregnant or breastfeeding women, or women planning pregnancy during the study period. 7. Current participation in any other clinical trial. 8. Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in DNA methylation-based biological age measured by iWatchAge | Baseline and Week 24 | Change in epigenetic biological age from baseline to Week 24, measured using the iWatchAge DNA methylation assay. This outcome reflects whether semaglutide, tirzepatide, or metformin can delay or reverse obesity-associated accelerated epigenetic aging. |
Countries
China
Contacts
Primary ContactChao Zheng
Outcome results
None listed