Comparative Observation of Metabolic and Pharmacologic Adipose Remodeling With Enhanced Incretin AgonisTs

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorTri-Service General Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Tirzepatide with lifestyle modification
  • Semaglutide with lifestyle modification

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Tri-Service General Hospital

Lead sponsor

National Science and Technology Council, Taiwan

Collaborator