Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07589322

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity and Metabolic Syndrome

Full registry criteria

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).

Treatments and study arms

Tirzepatide with lifestyle modification

Drug

Starting at Tirzepatide 2.5 mg weekly and escalated as tolerated to 10 mg along with standardized lifestyle counseling by a dietitian (caloric deficit, physical activity guidance) and written materials.

Semaglutide with lifestyle modification

Drug

Starting at Semaglutide 0.25 mg weekly and escalated as tolerated to 2.4 mg along with standardized lifestyle counseling by a dietitian (caloric deficit, physical activity guidance) and written materials.

Primary outcomes

Percent change in total body weight from baseline to 6 months.Baseline to 6 months

Total fat to lean mass loss ratio (DXA derived) from baseline to 6 months.Baseline to 6 months

Change in metabolic syndrome severity Z score from baseline to 6 months.Baseline to 6 months.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Tri-Service General Hospital🇹🇼 Taipei, Taiwan

Open map

Feng-Chih Kuo, M.D., Ph.D.Contact

Email · Call 886-2-87923311