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

NCT07589322 | Recruiting

• 1 other identifier: C202505161
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity and Metabolic Syndrome

Keywords

tirzepatide; semaglutide; obesity; metabolic syndrome; multi omic

Outcome Measures

Primary Outcomes (3)

• 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.

Secondary Outcomes (30)

• Change in waist circumference (cm)

  Baseline to 6 months and 12 months

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

  Baseline to 6 months and 12 months.

• Change in regional fat mass measured by DXA (grams)

  Baseline to 6 months and 12 months.

• Change in regional lean mass measured by DXA (grams)

  Baseline to 6 months and 12 months

• Change in 7-site skinfold thickness (mm)

  Baseline to 6 months and 12 months.

Study Arms (2)

Tirzepatide arm

ACTIVE COMPARATOR

starting at 2.5 mg weekly and escalated every month (5.0 mg, 7.5 mg to 10 mg) as tolerated

Drug: Tirzepatide with lifestyle modification

Semaglutide arm

ACTIVE COMPARATOR

starting at 0.25 mg weekly and escalated every month (0.5 mg, 1.0 mg, 1.7 mg to 2.4 mg) as tolerated

Drug: Semaglutide with lifestyle modification

Interventions

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.

Tirzepatide arm

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.

Semaglutide arm

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tri-Service General Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Tri-Service General Hospital

Taipei, 114202, Taiwan

RECRUITING

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Interventions

Tirzepatide; semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Feng-Chih Kuo, M.D., Ph.D.

  Division of Endocrinology and Metabolism, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical University, Taipei, Taiwan.

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

886-2-87923311; shoummie@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of the Division of Endocrinology and Metabolism, Principal Investigator, Associate Professor

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 15, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)