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NCT Number: NCT07423247

Tirzepatide (Spartina) in Obese Kidney Transplant Recipients

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.

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Key information

Conditions

Tirzepatide

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nooshin Dalili

Tehran, Iran

Location status: Recruiting

Location contact

SBMU

CONTACT

00989122404331

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Spartina

Primary outcomes

  1. Percent Change in Body Weight From Baseline at Week 24

    Time frame: Baseline to Week 24

    Percent change in body weight compared to baseline

  2. Incidence of Gastrointestinal Adverse Events

    Time frame: Baseline to Week 24 (monthly assessment)

    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

  3. Change in Serum Creatinine

    Time frame: Baseline to Week 24

    Change from baseline in serum creatinine (mg/dl).

Secondary outcomes

  1. Change in Body Mass Index (BMI)

    Time frame: Baseline to Week 24

    changes in BMI

  2. Change in Waist Circumference

    Time frame: Baseline to Week 24

    changes in centimeters

  3. Proportion of Participants Achieving Clinically Meaningful Weight Loss • Definition

    Time frame: week 24

    ≥5% and ≥10% weight loss from baseline

  4. change in tacrolimus trough Level

    Time frame: Monthly monitoring through Week 24

    Change from baseline in tacrolimus trough level (ng/ml)

  5. Change in Fasting blood glucose

    Time frame: Baseline to Week 24

    change from baseline in fasting blood glucose (mg/dl).

  6. Change in systolic blood pressure

    Time frame: Baseline to Week 24

    changes from baseline in systolic blood pressure(mmHg).

  7. Change in Proteinuria

    Time frame: Baseline to Week 24

    Urine protein-to-creatinine ratio (UPCR) or 24-hour urine protein

  8. Change in diastolic blood pressure

    Time frame: Baseline to week 24

    Change from baseline in diastolic blood pressure (mmHg).

Study contacts

Contact information is provided by the study sponsor or research team.

Nooshin Dalili, MD

CONTACT

[email protected]

00989122404331

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

Safety and Efficacy of Tirzepatide (Spartina) in Obese Kidney Transplant Recipients: A Pilot Study on Weight Loss, Gastrointestinal Tolerability, and Graft Function

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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