NCT07423247 Tirzepatide (Spartina) in Obese Kidney Transplant Recipients
| NCT ID | NCT07423247 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Shahid Beheshti University of Medical Sciences |
| Condition | Tirzepatide |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2026-01-01 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Post-transplant obesity is a common complication after kidney transplantation, largely attributed to recovery from uremia, increased appetite, sedentary lifestyle, and long-term corticosteroid exposure. Obesity in kidney transplant recipients increases the risk of cardiovascular disease, post-transplant diabetes mellitus (PTDM), and may contribute to graft injury through hyperfiltration-related mechanisms, potentially leading to reduced graft survival. Current approaches for weight management in transplant recipients, including lifestyle modification, are often insufficient, while bariatric surgery carries considerable risks and concerns regarding altered absorption of immunosuppressive medications. Tirzepatide (Iranian brand name: Spartina), the first dual agonist of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, has demonstrated superior effects on weight reduction and glycemic control compared with earlier GLP-1 receptor agonists in the general population. However, its use in kidney transplant recipients requires careful evaluation due to potential gastrointestinal adverse effects, dehydration risk, and possible interaction with calcineurin inhibitor absorption caused by delayed gastric emptying. This prospective single-arm pilot clinical trial aims to assess the preliminary safety and efficacy of tirzepatide in obese kidney transplant recipients with stable graft function. Outcomes include changes in anthropometric indices, percent weight change, gastrointestinal tolerability, immunosuppressive drug trough levels, and graft function over 24 weeks of treatment.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Kidney transplant recipient with ≥12 months since transplantation * BMI ≥ 27 kg/m² * Stable graft function in the last 3 months (serum creatinine variation \< 20%) * Stable immunosuppressive regimen * Ability to provide written informed consent Exclusion Criteria: * History of pancreatitis * Severe gastroparesis * History of medullary thyroid carcinoma (MTC) or MEN2 syndrome * eGFR \< 30 mL/min/1.73m² * Acute rejection episode within the past 6 months * Any condition judged by the investigator to interfere with study participation or safety
Contact & Investigator
Nooshin Dalili
PRINCIPAL INVESTIGATOR
SBMU
Frequently Asked Questions
Who can join the NCT07423247 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tirzepatide. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07423247 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07423247 currently recruiting?
Yes, NCT07423247 is actively recruiting participants. Contact the research team at dr.nooshindalili@gmail.com for enrollment information.
Where is the NCT07423247 trial being conducted?
This trial is being conducted at Tehran, Iran.
Who is sponsoring the NCT07423247 clinical trial?
NCT07423247 is sponsored by Shahid Beheshti University of Medical Sciences. The principal investigator is Nooshin Dalili at SBMU. The trial plans to enroll 30 participants.