NCT07423247RecruitingPhase 4
Tirzepatide (Spartina) in Obese Kidney Transplant Recipients
Safety and Efficacy of Tirzepatide (Spartina) in Obese Kidney Transplant Recipients: A Pilot Study on Weight Loss, Gastrointestinal Tolerability, and Graft Function
Source: ClinicalTrials.gov · Last updated 20 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 8 Feb 2026
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Diseases
- Obesity
- NCT number
- NCT07423247
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 30
- From 1 Jan 2026 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of pancreatitis
- History of medullary thyroid carcinoma (MTC) or MEN2 syndrome
- Any condition judged by the investigator to interfere with study participation or safety
Lab values
- eGFR \< 30 mL/min/1.73m²
Other
- Severe gastroparesis
- Acute rejection episode within the past 6 months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nooshin Dalili Coordinator of this site? Confirm its status | Tehran | Iran | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.