Trial · NCT07567378
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ACR20 response rate at Week 4 in the Mechanistic Analysis Set | week 4 | Proportion of patients in the Mechanistic Analysis Set (tirzepatide exposure ≤16 weeks at Week 0 and delta-BMI \<1.0 kg/m² through Week 4) achieving ACR20 response (American College of Rheumatology 20% improvement criteria) at Week 4, assessed by standardized clinical evaluation. |
| Primary | Proportion of Week-4 ACR20 response mediated by biomarker panel in the Mechanistic Analysis Set | Week 4 | Proportion of the Week-4 ACR20 response mediated by the combined biomarker panel (high-sensitivity C-reactive protein, SERPINB2, dipeptidyl peptidase-4 activity) in the Mechanistic Analysis Set, assessed by the MacKinnon product-of-coefficients method with 10,000 bias-corrected and accelerated (BCa) bootstrap iterations. Decision thresholds are prespecified in the Statistical Analysis Plan. |
| Secondary | Change in knee cartilage T2 relaxation time from Week 0 to Week 52 | Week 0 and week 52 | Change in femoro-tibial and patellar cartilage T2 relaxation time from Week 0 to Week 52, bilateral knees, stratified by zone (medial femur, lateral femur, medial tibia, lateral tibia, patella), analyzed at Ci3M UAM-Iztapalapa on Philips 3T platform. Primary analysis: linear mixed-effects model with random intercepts for patient and for knee-within-patient. |
| Secondary | Change in epicardial adipose tissue volume from Week 0 to Week 52 | week 0 and week 52 | Change in epicardial adipose tissue (EAT) volume from Week 0 to Week 52 by non-contrast cardiac CT with prospective ECG gating at the Instituto Nacional de Cardiología Ignacio Chávez. Primary analysis: linear mixed-effects model adjusted for baseline EAT volume, age, sex, and baseline BMI. Unit of Measure: milliliters (mL) |
| Secondary | Change in epicardial adipose tissue mean attenuation from Week 0 to Week 52 | week 0 and week 52 | Change in epicardial adipose tissue (EAT) mean attenuation from Week 0 to Week 52 on the same non-contrast cardiac CT acquisitions at the Instituto Nacional de Cardiología Ignacio Chávez. Primary analysis: linear mixed-effects model adjusted for baseline EAT mean attenuation, age, sex, and baseline BMI. Units of Measure: Hounsfield units (HU) |
| Secondary | Change in epicardial adipose tissue radiomic texture composite z-score from Week 0 to Week 52 | week 0 and week 52 | Change in a prespecified compact radiomic signature derived from up to five IBSI-standardized texture features (first-order, GLCM, GLRLM, GLSZM, NGTDM families) computed on non-contrast cardiac CT EAT segmentations and expressed as a normalized composite z-score, from Week 0 to Week 52. Primary analysis: linear mixed-effects model adjusted for baseline composite z-score, age, sex, and baseline BMI. Units of Measure: z-score (dimensionless) |
| Secondary | Longitudinal visceral adipose tissue trajectory over six timepoints | week 0 through week 52 | Visceral adipose tissue (VAT) volume by seca multi-frequency bioelectrical impedance analysis at Week 0, 2, 4, 12, 24, and 52 at Universidad La Salle México. Trajectory analyzed by linear mixed-effects model with random intercepts and slopes per patient. |
| Secondary | Longitudinal phase-angle trajectory (aging biomarker) over six timepoints | week 0 through week 52 | Bioimpedance phase angle (an established aging-biology biomarker) measured by seca mBCA at the six longitudinal timepoints. Trajectory and slope modeled per patient and stratified by baseline age tercile. |
| Secondary | HLA-stratified articular and cardiac response | week 4 and week 52 | ACR20 response at Week 4 and EAT radiomic change at Week 52 stratified by HLA Class I and Class II allele-group profile (INCMNSZ Transplant Department PCR-SSO Reverse Luminex typing). Hypothesis-generating. |
| Secondary | Change in Leeds Enthesitis Index (LEI) from Week 0 to Week 52 in the psoriatic arthritis subgroup | week 0 and week 52 | Change in LEI score (range 0-6, one point per tender enthesis at six prespecified entheseal sites) from Week 0 to Week 52 in the subgroup with CASPAR-positive psoriatic arthritis. Higher score indicates greater number of tender entheses. Primary analysis: paired t-test or Wilcoxon signed-rank within subgroup. Unit of Measure: score on a 0-6 scale (LEI) |
| Secondary | Change in Madrid Sonographic Enthesitis Index (MASEI) from Week 0 to Week 52 in the psoriatic arthritis subgroup | week 0 and week 52 | Change in MASEI score (range 0-136, sonographic assessment of six bilateral entheseal sites for elementary lesions and complications) from Week 0 to Week 52 in the subgroup with CASPAR-positive psoriatic arthritis. Higher score indicates greater sonographic enthesitis burden. Primary analysis: paired t-test or Wilcoxon signed-rank within subgroup. Unit of Measure: score on a 0-136 scale (MASEI) |
| Secondary | Transcriptomic signature of epicardial adipose tissue in tirzepatide-exposed participants undergoing cardiac surgery | At time of cardiac surgery, occurring within 36 months of enrolment | Bulk and/or single-nucleus RNA sequencing of epicardial adipose tissue fragments collected intraoperatively during clinically indicated cardiac surgery (coronary artery bypass grafting, valve replacement, or combined procedures) at the Instituto Nacional de Cardiología Ignacio Chávez. Differential gene expression and cell-type-resolved transcriptomic analysis compared between tirzepatide-exposed participants and matched non-exposed comparators. Prespecified secondary analyses include correlation of tissue transcriptomic signature with radiomic EAT phenotype and HLA profile in the same participants. |
| Secondary | Longitudinal biomarker panel trajectories | week 0 through week 52 | Longitudinal trajectories of high-sensitivity C-reactive protein, SERPINB2, dipeptidyl peptidase-4 activity, and related incretin-axis biomarkers measured in banked serum aliquots at the six longitudinal timepoints. Analyzed per patient and stratified by HLA profile. |
| Secondary | Change in modified Nail Psoriasis Severity Index (mNAPSI) from Week 0 to Week 52 in the psoriatic arthritis subgroup | Time Frame. Week 0 and Week 52. | Change in dermoscopy-graded modified Nail Psoriasis Severity Index (mNAPSI; range 0-130 if all 20 nails assessed) from Week 0 to Week 52 in the subgroup with CASPAR-positive psoriatic arthritis. Higher score indicates greater nail involvement. Primary analysis: paired t-test or Wilcoxon signed-rank within subgroup. Unit of Measure. score on a mNAPSI scale. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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