Obesity and Metabolic SyndromeCOMPARE-ATNCT07589322
Comparative Observation of Metabolic and Pharmacologic Adipose Remodeling With Enhanced Incretin AgonisTs
A study testing Tirzepatide with lifestyle modification and Semaglutide with lifestyle modification in people with Obesity and Metabolic Syndrome, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obesity and Metabolic Syndrome
- What is being tested?
- Tirzepatide with lifestyle modification and Semaglutide with lifestyle modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Mar 2026to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospital
Taipei, 114202
Feng-Chih Kuo, M.D., Ph.D., 886-2-87923311 ext. 12687, shoummie@hotmail.com
About this study
Official title: Comparative Adipose Tissue and Cardiometabolic System Remodeling by Tirzepatide and Semaglutide: an AI-integrated Multimodal Metabolomics and Translational Mechanistic Study
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.
Read the detailed description
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. The trial integrates pharmacologic weight-loss therapy with multimodal phenotyping to quantify changes across body composition, hepatic steatosis, metabolic biomarkers, functional strength, and AI-derived electrophysiologic signatures.
The scientific premise is that incretin-based therapies may produce qualitatively distinct patterns of fat loss, ectopic fat mobilization, and cardiometabolic improvement. Tirzepatide, a dual GIP/GLP-1 receptor agonist, may induce greater reductions in visceral adiposity and hepatic fat compared with GLP-1 receptor agonism alone. 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. Study visits occur at baseline, 3, 6, and 12 months, with deep phenotyping at baseline, 6, and 12 months.
The phenotyping framework emphasizes regional adiposity, lean mass preservation, hepatic steatosis, and cardiometabolic risk signatures. Whole-body DXA provides quantification of total and regional fat and lean mass, enabling derivation of fat-to-lean mass loss ratios and redistribution indices. Abdominal MRI with proton density fat fraction (PDFF) quantifies liver fat content and abdominal fat compartments. Functional and behavioral assessments-including grip strength and the Chinese version of the Weight-Related Eating Questionnaire-characterize changes in physical function and eating behavior patterns over time.
Fasting biochemical panels measure glycemic indices, lipid metabolism, inflammation, renal and hepatic function, and cardiometabolic biomarkers. Standard 12-lead ECGs are processed through a validated AI pipeline to generate electrophysiologic risk features (e.g., predicted ASCVD risk, ECG-derived heart age), which serve as exploratory digital biomarkers.
A centralized biobanking program supports mechanistic analyses. Serum, plasma, and PBMCs collected at each deep-phenotyping visit are stored under standardized SOPs for targeted and discovery-based metabolomic, proteomic, epigenetic and transcriptomic analyses. These biospecimens will enable downstream investigation of molecular pathways underlying differential treatment responses.
Together, this integrated platform allows for a comprehensive comparison of tirzepatide and semaglutide across structural, metabolic, functional, and molecular domains, providing mechanistic insight into how incretin-based therapies remodel adipose tissue and cardiometabolic physiology.
- Conditions
- Obesity and Metabolic Syndrome
- Being tested
- Tirzepatide with lifestyle modification, Semaglutide with lifestyle modification
- Keywords
- tirzepatide, semaglutide, obesity, metabolic syndrome, multi omic
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tirzepatide with lifestyle modificationDrug
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 modificationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Semaglutide with lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in total body weight from baseline to 6 months.
Measured: Baseline to 6 months
Total fat to lean mass loss ratio (DXA derived) from baseline to 6 months.
Measured: Baseline to 6 months
Change in metabolic syndrome severity Z score from baseline to 6 months.
Measured: Baseline to 6 months.
Secondary outcomes (30)
Change in waist circumference (cm)
Measured: Baseline to 6 months and 12 months
Change in waist-to-hip ratio (unitless ratio)
Measured: Baseline to 6 months and 12 months.
Change in regional fat mass measured by DXA (grams)
Measured: Baseline to 6 months and 12 months.
Change in regional lean mass measured by DXA (grams)
Measured: Baseline to 6 months and 12 months
Change in 7-site skinfold thickness (mm)
Measured: Baseline to 6 months and 12 months.
Change in liver fat content measured by MRI-PDFF (percentage, %PDFF)
Measured: Baseline to 6 months and 12 months
Change in abdominal visceral fat volume (mL)
Measured: Baseline to 6 months and 12 months
Change in abdominal subcutaneous fat volume (mL)
Measured: Baseline to 6 months and 12 months
Change in systolic and diastolic blood pressure (mmHg)
Measured: Baseline to 6 months and 12 months
Change in fasting lipid profile (mg/dL)
Lipid profile includes total cholesterol, LDL-C, HDL-C and Triglycerides
Measured: Baseline to 6 months and 12 months
Change in fasting glucose (mg/dL)
Measured: Baseline to 6 and 12 months
Change in hsCRP (mg/L)
Measured: Baseline to 6 and 12 months
Change in insulin sensitivity (HOMA-IR, unitless)
Measured: Baseline to 6 and 12 months
Change in β-cell function (HOMA-β, percentage, %)
Measured: Baseline to 6 and 12 months
Change in AI-ECG predicted ASCVD risk score (percentage, %)
Measured: Baseline to 6 and 12 months
Change in ECG-derived heart age (years)
Measured: Baseline to 6 and 12 months
Change in AI-ECG diabetes risk index (HbA1c, percentage, %)
Measured: Baseline to 6 and 12 months
Change in estimated 10-year ASCVD risk (percentage, %)
Measured: Baseline to 6 and 12 months
Change in bone mineral density (g/cm²)
Measured: Baseline to 6 and 12 months
Change in serum P1NP (ng/mL)
Measured: Baseline to 6 and 12 months
Change in serum CTX-1 (ng/mL)
Measured: Baseline to 6 and 12 months
Change in fasting plasma metabolomics profile (relative abundance units)
Measured: Baseline to 6 and 12 months
Change in fasting plasma proteomics profile (relative abundance units)
Measured: Baseline to 6 and 12 months
Change in microRNA expression signatures (normalized expression units)
Measured: Baseline to 6 and 12 months
Change in RNA-seq transcriptomic signatures (normalized counts, e.g., TPM)
Measured: Baseline to 6 and 12 months
Change in epigenetic methylation signatures (Methylation, percentage, %)
Measured: Baseline to 6 and 12 months
Change in depressive symptoms (scale score)
Instrument: e.g., PHQ-9
Measured: Baseline to 6 and 12 months
Change in sleep quality (scale score)
Instrument: e.g., PSQI
Measured: Baseline to 6 and 12 months
Change in quality of life (scale score)
Instrument: e.g., EQ-5D or SF-36
Measured: Baseline to 6 and 12 months
Change in eating behavior (WREQ-C total and subscale scores)
Measured: Baseline to 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start31 Mar 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Feng-Chih Kuo, Tri-Service General Hospital (TSGH)
- Investigators
- Feng-Chih Kuo, M.D., Ph.D., Study director, Division of Endocrinology and Metabolism, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical University, Taipei, Taiwan.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589322
- Sponsor's protocol ID
- C202505161
- Acronym
- COMPARE-AT
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is still ongoing and can not be shared before the final analysis.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Adipose Tissue and Cardiometabolic System Remodeling by Tirzepatide and Semaglutide: an AI-integrated Multimodal Metabolomics and Translational Mechanistic Study
- ClinicalTrials.gov ID
- NCT07589322
- Acronym / sponsor ID
- COMPARE-AT / C202505161
- Conditions
- Obesity and Metabolic Syndrome
- Keywords
- tirzepatide, semaglutide, obesity, metabolic syndrome, multi omic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. The trial integrates pharmacologic weight-loss therapy with multimodal phenotyping to quantify changes across body composition, hepatic steatosis, metabolic biomarkers, functional strength, and AI-derived electrophysiologic signatures.
The scientific premise is that incretin-based therapies may produce qualitatively distinct patterns of fat loss, ectopic fat mobilization, and cardiometabolic improvement. Tirzepatide, a dual GIP/GLP-1 receptor agonist, may induce greater reductions in visceral adiposity and hepatic fat compared with GLP-1 receptor agonism alone. 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. Study visits occur at baseline, 3, 6, and 12 months, with deep phenotyping at baseline, 6, and 12 months.
The phenotyping framework emphasizes regional adiposity, lean mass preservation, hepatic steatosis, and cardiometabolic risk signatures. Whole-body DXA provides quantification of total and regional fat and lean mass, enabling derivation of fat-to-lean mass loss ratios and redistribution indices. Abdominal MRI with proton density fat fraction (PDFF) quantifies liver fat content and abdominal fat compartments. Functional and behavioral assessments-including grip strength and the Chinese version of the Weight-Related Eating Questionnaire-characterize changes in physical function and eating behavior patterns over time.
Fasting biochemical panels measure glycemic indices, lipid metabolism, inflammation, renal and hepatic function, and cardiometabolic biomarkers. Standard 12-lead ECGs are processed through a validated AI pipeline to generate electrophysiologic risk features (e.g., predicted ASCVD risk, ECG-derived heart age), which serve as exploratory digital biomarkers.
A centralized biobanking program supports mechanistic analyses. Serum, plasma, and PBMCs collected at each deep-phenotyping visit are stored under standardized SOPs for targeted and discovery-based metabolomic, proteomic, epigenetic and transcriptomic analyses. These biospecimens will enable downstream investigation of molecular pathways underlying differential treatment responses.
Together, this integrated platform allows for a comprehensive comparison of tirzepatide and semaglutide across structural, metabolic, functional, and molecular domains, providing mechanistic insight into how incretin-based therapies remodel adipose tissue and cardiometabolic physiology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide arm | Active comparator | Drug: Tirzepatide with lifestyle modificationstarting at 2.5 mg weekly and escalated every month (5.0 mg, 7.5 mg to 10 mg) as tolerated |
| Semaglutide arm | Active comparator | Drug: Semaglutide with lifestyle modificationstarting at 0.25 mg weekly and escalated every month (0.5 mg, 1.0 mg, 1.7 mg to 2.4 mg) as tolerated |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tirzepatide with lifestyle modificationStarting 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. | Drug | Tirzepatide arm |
| Semaglutide with lifestyle modificationStarting 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. | Drug | Semaglutide arm |
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.
30 secondary outcomes
Change in waist circumference (cm)
Time frame: Baseline to 6 months and 12 months
Change in waist-to-hip ratio (unitless ratio)
Time frame: Baseline to 6 months and 12 months.
Change in regional fat mass measured by DXA (grams)
Time frame: Baseline to 6 months and 12 months.
Change in regional lean mass measured by DXA (grams)
Time frame: Baseline to 6 months and 12 months
Change in 7-site skinfold thickness (mm)
Time frame: Baseline to 6 months and 12 months.
Change in liver fat content measured by MRI-PDFF (percentage, %PDFF)
Time frame: Baseline to 6 months and 12 months
Change in abdominal visceral fat volume (mL)
Time frame: Baseline to 6 months and 12 months
Change in abdominal subcutaneous fat volume (mL)
Time frame: Baseline to 6 months and 12 months
Change in systolic and diastolic blood pressure (mmHg)
Time frame: Baseline to 6 months and 12 months
Change in fasting lipid profile (mg/dL)
Time frame: Baseline to 6 months and 12 months
Change in fasting glucose (mg/dL)
Time frame: Baseline to 6 and 12 months
Change in hsCRP (mg/L)
Time frame: Baseline to 6 and 12 months
Change in insulin sensitivity (HOMA-IR, unitless)
Time frame: Baseline to 6 and 12 months
Change in β-cell function (HOMA-β, percentage, %)
Time frame: Baseline to 6 and 12 months
Change in AI-ECG predicted ASCVD risk score (percentage, %)
Time frame: Baseline to 6 and 12 months
Change in ECG-derived heart age (years)
Time frame: Baseline to 6 and 12 months
Change in AI-ECG diabetes risk index (HbA1c, percentage, %)
Time frame: Baseline to 6 and 12 months
Change in estimated 10-year ASCVD risk (percentage, %)
Time frame: Baseline to 6 and 12 months
Change in bone mineral density (g/cm²)
Time frame: Baseline to 6 and 12 months
Change in serum P1NP (ng/mL)
Time frame: Baseline to 6 and 12 months
Change in serum CTX-1 (ng/mL)
Time frame: Baseline to 6 and 12 months
Change in fasting plasma metabolomics profile (relative abundance units)
Time frame: Baseline to 6 and 12 months
Change in fasting plasma proteomics profile (relative abundance units)
Time frame: Baseline to 6 and 12 months
Change in microRNA expression signatures (normalized expression units)
Time frame: Baseline to 6 and 12 months
Change in RNA-seq transcriptomic signatures (normalized counts, e.g., TPM)
Time frame: Baseline to 6 and 12 months
Change in epigenetic methylation signatures (Methylation, percentage, %)
Time frame: Baseline to 6 and 12 months
Change in depressive symptoms (scale score)
Time frame: Baseline to 6 and 12 months
Change in sleep quality (scale score)
Time frame: Baseline to 6 and 12 months
Change in quality of life (scale score)
Time frame: Baseline to 6 and 12 months
Change in eating behavior (WREQ-C total and subscale scores)
Time frame: Baseline to 3, 6, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No. It is still ongoing and can not be shared before the final analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feng-Chih Kuo, M.D., Ph.D. study director
Division of Endocrinology and Metabolism, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical University, Taipei, Taiwan.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tirzepatide with lifestyle modification and Semaglutide with lifestyle modification in people with Obesity and Metabolic Syndrome, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng-Chih Kuo, M.D., Ph.D. (886-2-87923311 ext. 12687, shoummie@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in total body weight from baseline to 6 months. (time frame: Baseline to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.