A Phase 4 interventional study of Tirzepatide in Tirzepatide, sponsored by Shahid Beheshti University of Medical Sciences. Recruiting at 1 site in Iran. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Shahid Beheshti University of Medical Sciences · Phase 4, Interventional, and Treatment
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.
Obesity following kidney transplantation is a frequent metabolic complication, related to improved appetite after resolution of uremia, reduced physical activity, and corticosteroid therapy. Post-transplant obesity is associated with increased risk of cardiovascular disease, PTDM, and chronic graft dysfunction. In addition, obesity-related hyperfiltration may accelerate structural injury to the transplanted kidney, potentially contributing to glomerulopathy and reduced graft survival.
Pharmacologic management of obesity in kidney transplant recipients remains challenging. Lifestyle-based interventions often fail to produce sustained weight loss. Bariatric surgery may be effective but is associated with increased risks in transplant recipients, including adhesions, infection, and altered absorption of immunosuppressive agents.
Tirzepatide is a dual GIP and GLP-1 receptor agonist with robust effects on weight reduction and glycemic control. Nevertheless, its safety profile in kidney transplant recipients remains insufficiently studied, particularly regarding gastrointestinal adverse events, dehydration risk, and the potential impact on immunosuppressive drug exposure due to delayed gastric emptying.
This study is designed as a prospective single-arm pilot clinical trial. Eligible kidney transplant recipients with obesity and stable graft function will receive weekly subcutaneous tirzepatide for 24 weeks using a stepwise dose escalation regimen. Participants will be monitored for changes in body weight, BMI, waist circumference, graft function parameters (serum creatinine and eGFR), metabolic indices (fasting glucose, HbA1c, lipid profile), gastrointestinal adverse events, and calcineurin inhibitor trough levels (tacrolimus or cyclosporine).
This pilot trial will provide preliminary evidence regarding feasibility, safety, and potential efficacy of tirzepatide in this high-risk transplant population and may guide the design of larger randomized controlled trials.
Exclusion Criteria:
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
Drug: Tirzepatide
* 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
Also known as: Spartina
Percent Change in Body Weight From Baseline at Week 24
Percent change in body weight compared to baseline
Time frame: Baseline to Week 24
Incidence of Gastrointestinal Adverse Events
Number of participants with gastrointestinal adverse events ( nausea, vomiting, diarrhea, constipation, abdominal pain) graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: Baseline to Week 24 (monthly assessment)
Change in Serum Creatinine
Change from baseline in serum creatinine (mg/dl).
Time frame: Baseline to Week 24
Change in Body Mass Index (BMI)
changes in BMI
Time frame: Baseline to Week 24
Change in Waist Circumference
changes in centimeters
Time frame: Baseline to Week 24
Proportion of Participants Achieving Clinically Meaningful Weight Loss • Definition
≥5% and ≥10% weight loss from baseline
Time frame: week 24
change in tacrolimus trough Level
Change from baseline in tacrolimus trough level (ng/ml)
Time frame: Monthly monitoring through Week 24
Change in Fasting blood glucose
change from baseline in fasting blood glucose (mg/dl).
Time frame: Baseline to Week 24
Change in systolic blood pressure
changes from baseline in systolic blood pressure(mmHg).
Time frame: Baseline to Week 24
Change in Proteinuria
Urine protein-to-creatinine ratio (UPCR) or 24-hour urine protein
Time frame: Baseline to Week 24
Change in diastolic blood pressure
Change from baseline in diastolic blood pressure (mmHg).
Time frame: Baseline to week 24
Plan to share: No
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Shahid Beheshti University of Medical Sciences