← Trials/Trial dossier/NCT07589322

COMPARE-AT

RecruitingPhase NA

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

Comparative Adipose Tissue and Cardiometabolic System Remodeling by Tirzepatide and Semaglutide: an AI-integrated Multimodal Metabolomics and Translational Mechanistic Study

Assets

Semaglutide / Tirzepatide

Listed sites

1

Recruiting sites

1

Enrollment

120

estimated

Study population

Metabolic syndrome, Obesity / overweight

Key I/E criterion

BMI ≥27

Primary endpoints

Body weight, % changeTotal fat to lean mass loss ratio (DXA derived)Metabolic syndrome severity Z score

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07589322
Org study IDC202505161

Timeline

Milestones

Study start2026-03-31actual
Study first posted2026-05-15actual
Last update posted2026-05-15actual
Primary completion2028-09-30estimated
Study completion2029-09-30estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Metabolic syndromeObesity / overweight

Eligibility

Who can enroll

Minimum age20 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

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.

Exclusion criteria

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).

Endpoints (33)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
9
Other (unclassified)
7
Cardiometabolic biomarkers
6
Glycemic / diabetes
4
Patient-reported / QoL
4
Other clinical outcomes
2
MASH / liver
1

Weight & body composition

9 endpoints
Primary/protocol endpoint

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

Time frame:Baseline to 6 months

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint/low confidence

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

Time frame:Baseline to 6 months

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference (cm)

Time frame:Baseline to 6 months and 12 months

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline to 6 months and 12 months.

change from baseline, improvement

Secondary/protocol endpoint

Change in regional fat mass measured by DXA (grams)

Time frame:Baseline to 6 months and 12 months.

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change in regional lean mass measured by DXA (grams)

Time frame:Baseline to 6 months and 12 months

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change in 7-site skinfold thickness (mm)

Time frame:Baseline to 6 months and 12 months.

change from baseline, improvement

Secondary/protocol endpoint

Change in abdominal visceral fat volume (mL)

Time frame:Baseline to 6 months and 12 months

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Change in abdominal subcutaneous fat volume (mL)

Time frame:Baseline to 6 months and 12 months

Subcutaneous fat, change

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Secondary/protocol endpoint

Change in fasting glucose (mg/dL)

Time frame:Baseline to 6 and 12 months

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in insulin sensitivity (HOMA-IR, unitless)

Time frame:Baseline to 6 and 12 months

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Change in β-cell function (HOMA-β, percentage, %)

Time frame:Baseline to 6 and 12 months

percent change from baseline, improvement

Secondary/protocol endpoint

Change in AI-ECG diabetes risk index (HbA1c, percentage, %)

Time frame:Baseline to 6 and 12 months

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

MASH / liver

1 endpoint
Secondary/protocol endpoint

Change in liver fat content measured by MRI-PDFF (percentage, %PDFF)

Time frame:Baseline to 6 months and 12 months

MRI-PDFF, % change

percent change from baseline, improvement

Cardiometabolic biomarkers

6 endpoints
Secondary/protocol endpoint

Change in systolic and diastolic blood pressure (mmHg)

Time frame:Baseline to 6 months and 12 months

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Secondary/protocol endpoint

Change in fasting lipid profile (mg/dL)

Time frame:Baseline to 6 months and 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in hsCRP (mg/L)

Time frame:Baseline to 6 and 12 months

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in AI-ECG predicted ASCVD risk score (percentage, %)

Time frame:Baseline to 6 and 12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in ECG-derived heart age (years)

Time frame:Baseline to 6 and 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in estimated 10-year ASCVD risk (percentage, %)

Time frame:Baseline to 6 and 12 months

change from baseline, improvement

Patient-reported / QoL

4 endpoints
Secondary/protocol endpoint

Change in depressive symptoms (scale score)

Time frame:Baseline to 6 and 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in sleep quality (scale score)

Time frame:Baseline to 6 and 12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in quality of life (scale score)

Time frame:Baseline to 6 and 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in eating behavior (WREQ-C total and subscale scores)

Time frame:Baseline to 3, 6, and 12 months

change from baseline, improvement

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint

Change in bone mineral density (g/cm²)

Time frame:Baseline to 6 and 12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in serum P1NP (ng/mL)

Time frame:Baseline to 6 and 12 months

change from baseline, improvement

Other (unclassified)

7 endpoints
Primary/protocol endpoint/low confidence

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

Time frame:Baseline to 6 months.

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in serum CTX-1 (ng/mL)

Time frame:Baseline to 6 and 12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in fasting plasma metabolomics profile (relative abundance units)

Time frame:Baseline to 6 and 12 months

descriptive

Secondary/protocol endpoint/low confidence

Change in fasting plasma proteomics profile (relative abundance units)

Time frame:Baseline to 6 and 12 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in microRNA expression signatures (normalized expression units)

Time frame:Baseline to 6 and 12 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in RNA-seq transcriptomic signatures (normalized counts, e.g., TPM)

Time frame:Baseline to 6 and 12 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in epigenetic methylation signatures (Methylation, percentage, %)

Time frame:Baseline to 6 and 12 months

percent change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.