Tirzepatide (Spartina) in Obese Kidney Transplant Recipients

Sponsor
Shahid Beheshti University of Medical Sciences
Study ID
NCT07423247
Phase
PHASE4
Status
Recruiting
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Conditions

  • Tirzepatide

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    * Route: Subcutaneous injection (SC) * Frequency: Once weekly * Duration: 24 weeks * Dose escalation: * Weeks 1-4: 2.5 mg weekly * Weeks 5-8: 5 mg weekly (if tolerated) * Weeks 9-24: Continue 5 mg weekly or increase to 7.5 mg weekly based on tolerability and physician judgment

Study Details

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.

Key Dates

Start date
Jan 1, 2026
Status verified
Feb 2026
Primary completion
Jul 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide(Spartina)
    Route: Subcutaneous injection (SC) * Frequency: Once weekly * Duration: 24 weeks * Dose escalation: * Weeks 1-4: 2.5 mg weekly * Weeks 5-8: 5 mg weekly (if tolerated) * Weeks 9-24: Continue 5 mg weekly or increase to 7.5 mg weekly based on tolerability and physician judgment

Primary Outcome Measure

Percent Change in Body Weight From Baseline at Week 24 [ Time Frame: Baseline to Week 24 ]

Central Contacts

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