drugset / Trial / NCT07589322

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

NCT07589322

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2026-03-31
Primary completion
2028-09-30
Completion
2029-09-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Semaglutide Peptide 2.4 mg
Comparator Tirzepatide Peptide 10 mg