TirzepatidePhase 4NCT07423247
Tirzepatide (Spartina) in Obese Kidney Transplant Recipients
A Phase 4 study testing Tirzepatide in people with Tirzepatide, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tirzepatide
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2026to Sep 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Efficacy of Tirzepatide (Spartina) in Obese Kidney Transplant Recipients: A Pilot Study on Weight Loss, Gastrointestinal Tolerability, and Graft Function
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.
Read the detailed description
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.
- Conditions
- Tirzepatide
- Being tested
- Tirzepatide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Body Weight From Baseline at Week 24
Percent change in body weight compared to baseline
Measured: 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
Measured: Baseline to Week 24 (monthly assessment)
Change in Serum Creatinine
Change from baseline in serum creatinine (mg/dl).
Measured: Baseline to Week 24
Secondary outcomes (8)
Change in Body Mass Index (BMI)
changes in BMI
Measured: Baseline to Week 24
Change in Waist Circumference
changes in centimeters
Measured: Baseline to Week 24
Proportion of Participants Achieving Clinically Meaningful Weight Loss • Definition
≥5% and ≥10% weight loss from baseline
Measured: week 24
change in tacrolimus trough Level
Change from baseline in tacrolimus trough level (ng/ml)
Measured: Monthly monitoring through Week 24
Change in Fasting blood glucose
change from baseline in fasting blood glucose (mg/dl).
Measured: Baseline to Week 24
Change in systolic blood pressure
changes from baseline in systolic blood pressure(mmHg).
Measured: Baseline to Week 24
Change in Proteinuria
Urine protein-to-creatinine ratio (UPCR) or 24-hour urine protein
Measured: Baseline to Week 24
Change in diastolic blood pressure
Change from baseline in diastolic blood pressure (mmHg).
Measured: Baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Jan 2026
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TirzepatideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nooshin dalili, Shahid Beheshti University of Medical Sciences
- Investigators
- Nooshin Dalili, Principal investigator, SBMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423247
- Sponsor's protocol ID
- SBMU-12-1404
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Tirzepatide (Spartina) in Obese Kidney Transplant Recipients: A Pilot Study on Weight Loss, Gastrointestinal Tolerability, and Graft Function
- ClinicalTrials.gov ID
- NCT07423247
- Acronym / sponsor ID
- SBMU-12-1404
- Conditions
- Tirzepatide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide(Spartina) | Experimental | Drug: TirzepatideRoute: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: 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 | Drug | Tirzepatide(Spartina) |
Primary outcome
Percent Change in Body Weight From Baseline at Week 24
Time frame: Baseline to Week 24
Percent change in body weight compared to baseline
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
Change in Serum Creatinine
Time frame: Baseline to Week 24
Change from baseline in serum creatinine (mg/dl).
8 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: Baseline to Week 24
Change in Waist Circumference
Time frame: Baseline to Week 24
Proportion of Participants Achieving Clinically Meaningful Weight Loss • Definition
Time frame: week 24
change in tacrolimus trough Level
Time frame: Monthly monitoring through Week 24
Change in Fasting blood glucose
Time frame: Baseline to Week 24
Change in systolic blood pressure
Time frame: Baseline to Week 24
Change in Proteinuria
Time frame: Baseline to Week 24
Change in diastolic blood pressure
Time frame: Baseline to week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Tirzepatide
RecruitingPhase 3
A Study to Learn About Switching to a Monthly Study Medicine Called Berobenatide (PF-08653944) to Help Keep Weight Off in People With Overweight or Obesity
Obesity, Overweight and/or Obesity
RecruitingPhase 4
AI-Assisted Lifestyle Intervention Versus Tirzepatide for Obesity and Newly Diagnosed Type 2 Diabetes
Obesity, Diabetes Mellitus, Type 2
RecruitingPhase 3
Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)
Obesity
RecruitingPhase 3
Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
Crohn's Disease, Obesity or Overweight
RecruitingPhase 3
Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study
Ulcerative Colitis, Obesity or Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nooshin Dalili principal investigator
SBMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tirzepatide in people with Tirzepatide, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nooshin Dalili, MD (00989122404331, dr.nooshindalili@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Body Weight From Baseline at Week 24 (time frame: Baseline to Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.