Tirzepatide (Spartina) in Obese Kidney Transplant Recipients

NCT07423247 | Recruiting Phase 4

• 1 other identifier: SBMU-12-1404
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tirzepatide

Outcome Measures

Primary Outcomes (3)

• Percent Change in Body Weight From Baseline at Week 24

  Percent change in body weight compared to baseline

  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

  Baseline to Week 24 (monthly assessment)

• Change in Serum Creatinine

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

  Baseline to Week 24

Secondary Outcomes (8)

• Change in Body Mass Index (BMI)

  Baseline to Week 24

• Change in Waist Circumference

  Baseline to Week 24

• Proportion of Participants Achieving Clinically Meaningful Weight Loss • Definition

  week 24

• change in tacrolimus trough Level

  Monthly monitoring through Week 24

• Change in Fasting blood glucose

  Baseline to Week 24

Study Arms (1)

Tirzepatide(Spartina)

EXPERIMENTAL

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

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

Also known as: Spartina

Tirzepatide(Spartina)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Nooshin Dalili

Tehran, Iran

RECRUITING

MeSH Terms

Interventions

Tirzepatide

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Nooshin Dalili

  SBMU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nooshin Dalili, MD

CONTACT

00989122404331; dr.nooshindalili@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nephrology

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: February 20, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)