Health TrialsbyHealthPanel

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

ConditionObesity and Metabolic Syndrome
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Tirzepatide armActive comparator 1 intervention
Group B: Semaglutide armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline to 6 months
2

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

Time frame
Baseline to 6 months
3

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

Time frame
Baseline to 6 months.

Secondary outcomes

1

Change in waist circumference (cm)

Time frame
Baseline to 6 months and 12 months
2

Change in waist-to-hip ratio (unitless ratio)

Time frame
Baseline to 6 months and 12 months.
3

Change in regional fat mass measured by DXA (grams)

Time frame
Baseline to 6 months and 12 months.
4

Change in regional lean mass measured by DXA (grams)

Time frame
Baseline to 6 months and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tri-Service General Hospital

Lead sponsor

National Science and Technology Council, Taiwan

Collaborator

Source ClinicalTrials.gov
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