Tirzepatide for weight loss after kidney transplant
Safety and Efficacy of Tirzepatide (Spartina) in Obese Kidney Transplant Recipients: A Pilot Study on Weight Loss, Gastrointestinal Tolerability, and Graft Function
This will test whether weekly tirzepatide helps adults at least one year after a kidney transplant lose weight and improve blood sugar and kidney-related outcomes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shahid Beheshti University of Medical Sciences Academic / other |
| Locations | 1 site (Tehran) |
| Trial ID | NCT07423247 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm pilot study enrolling adults at least 12 months after kidney transplantation with BMI ≥27 kg/m² and stable graft function. Participants will receive once-weekly subcutaneous tirzepatide for 24 weeks with a stepwise dose escalation and close monitoring. The protocol emphasizes safety monitoring for gastrointestinal adverse events, dehydration, and effects on immunosuppressive drug exposure and graft function. Outcomes include weight change, glycemic measures, renal function stability, and adverse events.
Who should consider this trial
Good fit: Adults (≥18 years) at least 12 months post-kidney transplant with BMI ≥27 kg/m², stable serum creatinine over the prior 3 months, and a stable immunosuppressive regimen are ideal candidates.
Not a fit: Patients with eGFR <30 mL/min/1.73m², recent acute rejection, history of pancreatitis, severe gastroparesis, or medullary thyroid carcinoma/MEN2 are excluded and unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, tirzepatide could provide meaningful weight loss and improved metabolic control for transplant recipients while helping protect long-term graft and cardiovascular health.
How similar studies have performed: Tirzepatide has produced large weight loss and better glycemic control in non-transplant populations, but its safety and effects in kidney transplant recipients remain largely untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tehran
- Nooshin Dalili — Tehran, Iran (Recruiting)
Study contacts
- Principal investigator: Nooshin Dalili — Sbmu
- Study coordinator: Nooshin Dalili, MD
- Email: dr.nooshindalili@gmail.com
- Phone: 00989122404331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.