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CARTIZ

Not yet recruiting

CARTIZ Registry: Cartilage, Arthropathy and Imaging Under Tirzepatide in Zone-stratified Cohorts - A Four-Institute Mexican Observational Registry

Cartilage, Arthropathy and Imaging Under Tirzepatide in Zone-stratified Cohorts (CARTIZ): A Prospective Observational Multi-Institutional Registry of the VAT-Articular-Cardiac-Aging Axis in Adults Exposed to Tirzepatide in Mexico, With Quantitative Knee Cartilage T2 Mapping, Cardiac CT Epicardial Adipose Tissue Radiomic Phenotyping, HLA Stratification, Longitudinal Multi-Frequency Bioimpedance Body Composition, and a Prespecified Surgical Tissue Acquisition Subcohort

Assets

GLP-1 / incretin class catch-all / Tirzepatide

Listed sites

1

Recruiting sites

Enrollment

30

estimated

Study population

Osteoarthritis, Psoriasis / psoriatic arthritis

Key I/E criterion

Primary endpoints

ACR20 response rateProportion of Week-4 ACR20 response mediated by biomarker panel in

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 IDNCT07567378
Org study IDCARTIZ-2026-001
Secondary ID64/019,134USPTO
Secondary ID64/031,635USPTO
Secondary ID64/039,918USPTO
Secondary ID64/043,606USPTO

Timeline

Milestones

Study first posted2026-05-05actual
Last update posted2026-05-12actual
Study start2026-05estimated (month precision)
Primary completion2027-11estimated (month precision)
Study completion2029-05estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

OsteoarthritisPsoriasis / psoriatic arthritis

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Adults receiving tirzepatide under an independent clinical indication (type 2 diabetes, insulin resistance, obesity with or without associated metabolic disease, renal protection, metabolic hypertension, or off-label metabolic use) with current or historical documented musculoskeletal manifestation, enrolled across three clinical sites in Mexico City with identical protocol: IMSS Clínica Río Magdalena, INCMNSZ outpatient clinic, and a private practice site. The population is deliberately heterogeneous in tirzepatide indication and articular diagnosis to permit stratified analysis across the VAT-articular-cardiac-aging axis.

Inclusion criteria

1. Age ≥18 years at the time of informed consent. 2. Currently receiving tirzepatide under an independent clinical indication (type 2 diabetes, insulin resistance, obesity with or without associated metabolic disease, renal protection, metabolic hypertension, or associated off-label metabolic use) prescribed by the treating physician independently of the registry.

3. Presence of at least one objectively documented musculoskeletal manifestation - current or historical - defined as any of: (i) inflammatory arthralgia affecting one or more joints with clinical, imaging, or serological support; (ii) CASPAR-positive psoriatic arthritis; (iii) radiographically documented knee osteoarthritis; (iv) enthesitis on physical examination or ultrasound; (v) documented inflammatory arthropathy of the spine or peripheral joints with a specialist diagnosis.

4. For the retrospective-prospective component: availability of clinical documentation of articular state prior to tirzepatide initiation in the patient's medical record. Documentation may include physical examination notes, imaging, laboratory values, or specialist consultation notes.

5. Signed informed consent for registry enrolment, longitudinal serum biobanking, HLA typing at INCMNSZ, quantitative knee MRI with T2 mapping at Ci3M UAM-Iztapalapa at Week 0 and Week 52, non-contrast cardiac CT at INCar at Week 0 and Week 52, multi-frequency bioelectrical impedance analysis at Universidad La Salle México at six timepoints, and (where applicable) medical record review. Each attestation is consented modularly within a single document.

6. Clinical plan to continue tirzepatide for at least 52 weeks from registry Week 0, based on the treating physician's evaluation of current clinical indication. Discontinuation during follow-up is captured as an outcome variable and does not remove the patient from the registry.

7. Capacity to attend scheduled follow-up visits and to undergo bilateral knee MRI at Ci3M (without severe claustrophobia requiring sedation, without absolute contraindication to MRI - see Exclusion 6) and non-contrast cardiac CT at INCar (without uncontrolled arrhythmia precluding ECG-gated imaging of diagnostic quality).

For the Surgical Tissue Subcohort (Cohort 3) only - additional criteria applied at the time of subcohort enrolment:

8s. Scheduled clinically indicated cardiac surgery at the Instituto Nacional de Cardiología Ignacio Chávez (coronary artery bypass grafting, valve replacement, or combined procedures) during registry follow-up.

9s. Specific additional informed consent for intraoperative collection of epicardial adipose tissue fragments.

Exclusion criteria

1. Initiation or modification of a biologic disease-modifying antirheumatic drug (biologic DMARD) or JAK inhibitor within the 12 weeks prior to Week 0, or clinically anticipated initiation or modification during the first 12 weeks of follow-up. Washout may permit re-screening.

2. Major joint surgery within the 3 months prior to Week 0, or planned major joint surgery within the 12 months following Week 0, involving any joint scheduled for evaluation in the registry.

3. Intra-articular corticosteroid or hyaluronic acid injection within the 6 weeks prior to baseline biospecimen collection in any joint. Patients beyond the 6-week washout are eligible.

4. Active malignancy, with the exception of adequately treated non-melanoma skin carcinoma. History of malignancy in remission ≥5 years is permitted at the discretion of the treating investigator.

5. Current pregnancy, lactation, or planned pregnancy within the 12-month observation period.

6. Absolute contraindication to MRI, including non-MRI-compatible cardiac pacemaker or implanted defibrillator, ferromagnetic intracranial vascular clips, non-documented non-MRI-compatible cochlear implants, or other contraindication per the local MRI safety protocol.

7. Systemic rheumatologic disease other than psoriatic arthritis or osteoarthritis requiring active immunomodulation, specifically: seropositive rheumatoid arthritis on biologic therapy, active systemic lupus erythematosus on immunomodulation, active vasculitis on immunosuppression, or other systemic disease whose treatment confounds the inflammatory axis the registry is designed to characterize.

8. Inability to provide informed consent (cognitive impairment, language barrier not resolvable with site interpreter, or other incapacity to understand the protocol), or anticipated inability to complete the 52-week follow-up.

For the Surgical Tissue Subcohort (Cohort 3) only - additional exclusions:

9s. Prior major cardiac surgery resulting in extensive pericardial adhesions that preclude safe intraoperative EAT fragment collection, as assessed by the operating cardiac surgeon.

10s. Emergency cardiac surgery precluding the specific informed consent process.

Endpoints (14)

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

Other clinical outcomes
6
Weight & body composition
4
Other (unclassified)
3
Cardiometabolic biomarkers
1

Weight & body composition

4 endpoints
Secondary/protocol endpoint

Change in epicardial adipose tissue volume from Week 0 to Week 52

Time frame:week 0 and week 52

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Change in epicardial adipose tissue mean attenuation from Week 0 to Week 52

Time frame:week 0 and week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in epicardial adipose tissue radiomic texture composite z-score from Week 0 to Week 52

Time frame:week 0 and week 52

change from baseline, improvement

Secondary/protocol endpoint

Longitudinal visceral adipose tissue trajectory over six timepoints

Time frame:week 0 through week 52

Visceral fat, change

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Longitudinal biomarker panel trajectories

Time frame:week 0 through week 52

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Other clinical outcomes

6 endpoints
Primary/protocol endpoint

ACR20 response rate at Week 4 in the Mechanistic Analysis Set

Time frame:week 4

threshold achievement, improvement

Primary/protocol endpoint/low confidence

Proportion of Week-4 ACR20 response mediated by biomarker panel in the Mechanistic Analysis Set

Time frame:Week 4

descriptive

Secondary/protocol endpoint/low confidence

Change in knee cartilage T2 relaxation time from Week 0 to Week 52

Time frame:Week 0 and week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change in Leeds Enthesitis Index (LEI) from Week 0 to Week 52 in the psoriatic arthritis subgroup

Time frame:week 0 and week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Madrid Sonographic Enthesitis Index (MASEI) from Week 0 to Week 52 in the psoriatic arthritis subgroup

Time frame:week 0 and week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in modified Nail Psoriasis Severity Index (mNAPSI) from Week 0 to Week 52 in the psoriatic arthritis subgroup

Time frame:Time Frame. Week 0 and Week 52.

change from baseline, improvement

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Longitudinal phase-angle trajectory (aging biomarker) over six timepoints

Time frame:week 0 through week 52

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

HLA-stratified articular and cardiac response

Time frame:week 4 and week 52

descriptive

componentsacr20 response, epicardial adipose tissue radiomic change

Secondary/protocol endpoint/low confidence

Transcriptomic signature of epicardial adipose tissue in tirzepatide-exposed participants undergoing cardiac surgery

Time frame:At time of cardiac surgery, occurring within 36 months of enrolment

descriptive

Publications (7)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.