Comparative Observation of Metabolic and Pharmacologic Adipose Remodeling With Enhanced Incretin AgonisTs
Recruiting · NCT07589322 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Semaglutide with lifestyle modificationTirzepatide with lifestyle modification
What this trial is about
This randomized, open label, head to head clinical trial directly compares tirzepatide and semaglutide in adults with obesity and metabolic syndrome (N=120, age 20-65, 1:1 randomization). Participants undergo deep phenotyping at baseline, 6 months, and 12 months, including DXA (regional fat, lean mass, and BMD), MRI PDFF (liver fat), 7 site skinfold thickness, grip strength, fasting biochemistry, and AI processed 12 lead ECGs. Centralized biobanking of serum, plasma, and PBMCs enables targeted and discovery multi omic analyses.
Who can take part
Age range
20 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age 20-65 years.
- BMI ≥27 kg/m² with metabolic syndrome (ATP III or IDF criteria).
- Stable background medications (antihypertensives, statins, etc.) for ≥3 months.
- Able and willing to provide informed consent and comply with study procedures.
Exclusion criteria
- History of diabetes; history of pancreatitis; personal/family history of medullary thyroid carcinoma or MEN2.
- eGFR \<30 mL/min/1.73 m², decompensated liver disease, NYHA class III-IV heart failure.
- Recent (\<3 months) acute coronary syndrome, stroke, or coronary revascularization.
- Current use of GLP 1RA, tirzepatide, or other incretin based therapies within 3 months.
- Contraindications to MRI or DXA (e.g., metal implants incompatible with MRI, pregnancy).
Where it is running
1 location listed.
- Tri-Service General Hospital - Taipei, Taiwan