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

What Was Tested

The trial (not phased) is built around Tirzepatide and Semaglutide.

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.

It had two arms (groups): Tirzepatide arm (active comparator) and Semaglutide arm (active comparator).

The registry classes the interventions as drug.

More on the Plan

This study is a single-center, randomized, open-label, active-comparator trial designed to characterize the differential effects of tirzepatide and semaglutide on adipose tissue biology and cardiometabolic remodeling over 12 months in adults with obesity and metabolic syndrome.

This trial is designed to directly compare these mechanistic profiles using harmonized imaging, biochemical, and digital phenotyping platforms.

Participants are randomized 1:1 to tirzepatide or semaglutide using a computer-generated permuted block scheme stratified by sex and baseline BMI category.

Both interventions follow standard titration schedules and are paired with structured lifestyle counseling to ensure comparable background care.

Who Took Part

Enrollment: 120 planned participants were the target.

It was open to people of any sex aged from 20 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: history of diabetes; history of pancreatitis; personal/family history of medullary thyroid carcinoma or men2; recent (\<3 months) acute coronary syndrome, stroke, or coronary revascularization; current use of glp 1ra, tirzepatide, or other incretin based therapies within 3 months.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Everyone knew when Tirzepatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2026-03-31 with completion listed for 2028-09-30.

It ran at 1 site in Taiwan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent change in total body weight from baseline to 6 months (time frame: Baseline to 6 months). Total fat to lean mass loss ratio (DXA derived) from baseline to 6 months (time frame: Baseline to 6 months). Change in metabolic syndrome severity Z score from baseline to 6 months (time frame: Baseline to 6 months).

It also tracked 30 secondary outcomes, for example Change in waist circumference (cm), Change in waist-to-hip ratio (unitless ratio), Change in regional fat mass measured by DXA (grams), Change in regional lean mass measured by DXA (grams), Change in 7-site skinfold thickness (mm) and Change in liver fat content measured by MRI-PDFF (percentage, %PDFF).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Tirzepatide and Semaglutide in 120 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page and the Semaglutide compound page, all human trials.