Printed from Voxsanity (voxsanity.com.au) — NCT07567378 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Type 2 Diabetes Trial, Not Yet Recruiting
NCT07567378
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who are 18 years of age or older at the time of signing the consent form.
- People who are currently taking tirzepatide, prescribed by their own doctor (independently of this registry), for an approved or accepted use such as type 2 diabetes, insulin resistance, obesity (with or without related metabolic conditions), kidney protection, metabolic high blood pressure, or a related off-label metabolic use.
- People who have at least one documented joint or musculoskeletal problem — either current or in the past — such as: joint pain with inflammation supported by clinical findings, imaging, or blood tests; psoriatic arthritis meeting specific diagnostic criteria (CASPAR criteria); knee osteoarthritis confirmed by X-ray; enthesitis (inflammation where tendons or ligaments attach to bone) found on physical examination or ultrasound; or an inflammatory joint condition of the spine or other joints diagnosed by a specialist.
- For people entering the retrospective-prospective part of the study: medical records must be available showing the state of their joints before they started taking tirzepatide, such as examination notes, imaging, lab results, or specialist letters.
- People who are willing and able to sign a consent form covering registry enrolment, blood sample storage over time, genetic (HLA) typing at INCMNSZ, knee MRI scans at Ci3M UAM-Iztapalapa at the start and at 52 weeks, non-contrast heart CT scans at INCar at the start and at 52 weeks, body composition measurements at Universidad La Salle México at six timepoints, and (where relevant) review of medical records — with each of these consented as separate modules within one document.
- People whose treating doctor plans for them to continue tirzepatide for at least 52 weeks from the registry start date, based on their ongoing clinical need (note: if tirzepatide is stopped during follow-up, this is recorded as an outcome and does not remove the person from the registry).
- People who are able to attend scheduled follow-up visits, undergo knee MRI at Ci3M (without severe claustrophobia requiring sedation and without a medical reason that prevents MRI — see exclusion criterion 6), and undergo a non-contrast heart CT at INCar (without an uncontrolled heart rhythm problem that would prevent a good-quality scan).
- For the Surgical Tissue Subcohort (Cohort 3) only — additional criteria checked at the time of joining that subcohort: people who have a clinically necessary heart surgery scheduled at the Instituto Nacional de Cardiología Ignacio Chávez (such as bypass surgery, valve replacement, or a combined procedure) during the registry follow-up period.
- For the Surgical Tissue Subcohort (Cohort 3) only: people who are willing to sign an additional consent for a small sample of heart fat tissue (epicardial adipose tissue) to be collected during their surgery.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have started or changed a biologic disease-modifying medication or JAK inhibitor within the 12 weeks before the registry start date, or who are expected to do so within the first 12 weeks of follow-up (a waiting period after stopping these medications may allow re-screening — confirm with trial site).
- People who have had major surgery on a joint being evaluated in this study within the 3 months before the registry start date, or who have planned major joint surgery within 12 months after the registry start date.
- People who have received a steroid or hyaluronic acid injection into any joint within the 6 weeks before the baseline sample collection for that joint (people who are past that 6-week period may be eligible — confirm with trial site).
- People with an active cancer diagnosis, except for certain treated skin cancers (non-melanoma); people with a history of cancer that has been in remission for 5 or more years may still be considered, at the treating investigator's discretion.
- People who are currently pregnant, breastfeeding, or planning to become pregnant during the 12-month observation period.
- People who have a medical reason that makes MRI unsafe, such as a non-MRI-compatible heart pacemaker or implanted defibrillator, certain types of metal clips in the brain, cochlear implants that are not confirmed to be MRI-compatible, or any other contraindication identified under the local MRI safety guidelines.
- People with a systemic (whole-body) rheumatic disease other than psoriatic arthritis or osteoarthritis that requires active immune-suppressing treatment — for example, seropositive rheumatoid arthritis on biologic therapy, active lupus on immunomodulating treatment, active vasculitis on immunosuppression, or another systemic condition whose treatment would interfere with what the study is measuring.
- People who are unable to give informed consent due to cognitive difficulties, a language barrier that cannot be resolved with an on-site interpreter, or any other reason that prevents understanding of the study, or who are not expected to be able to complete the 52-week follow-up.
- For the Surgical Tissue Subcohort (Cohort 3) only: people whose previous heart surgery has caused scarring around the heart (pericardial adhesions) that would make it unsafe to collect a tissue sample during the operation, as assessed by the cardiac surgeon.
- For the Surgical Tissue Subcohort (Cohort 3) only: people whose heart surgery is an emergency, as there would not be sufficient time to complete the specific consent process for tissue collection.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.
Contact this trial
Principal Investigator: Julio Granados-Montiel, MD, PhD, Universidad La Salle
Phone: +52 5554329237
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Not Applicable
Sponsor
JULIO GRANADOS MONTIEL
Registry
ClinicalTrials.gov
Start date
1 May 2026
Est. completion
1 November 2027
Where this trial is recruiting
🇲🇽 Mexico
Primary endpoints
ACR20 response rate at Week 4 in the Mechanistic Analysis Set; Proportion of Week-4 ACR20 response mediated by biomarker panel in the Mechanistic Analysis Set
Can't join this trial?
Data last synced from ClinicalTrials.gov: 4 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.