DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07423247

RecruitingPhase 4

Tirzepatide (Spartina) in Obese Kidney Transplant Recipients

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

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

30

estimated

Study population

Obesity / overweight, Renal impairment

Key I/E criterion

•BMI ≥27

Primary endpoints

•Body weight, % change•Gastrointestinal Adverse Events (Nausea, Vomiting, Diarrhea)•Serum Creatinine

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07423247
Org study IDSBMU-12-1404

Timeline

Milestones

Study start2026-01-01actual
Study first posted2026-02-20actual
Last update posted2026-02-20actual
Primary completion2026-07estimated (month precision)
Study completion2026-09estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightRenal impairment

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
4
Renal / kidney
2
Cardiometabolic biomarkers
2
Glycemic / diabetes
1
Safety / tolerability / PK
1
Other (unclassified)
1

Weight & body composition

4 endpoints
Primary/protocol endpoint

Percent Change in Body Weight From Baseline at Week 24

Time frame:Baseline to Week 24

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI)

Time frame:Baseline to Week 24

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Baseline to Week 24

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Proportion of Participants Achieving Clinically Meaningful Weight Loss • Definition

Time frame:week 24

≥5% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change in Fasting blood glucose

Time frame:Baseline to Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Renal / kidney

2 endpoints
Primary/protocol endpoint

Change in Serum Creatinine

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change in Proteinuria

Time frame:Baseline to Week 24

ratio, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Change in systolic blood pressure

Time frame:Baseline to Week 24

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in diastolic blood pressure

Time frame:Baseline to week 24

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Incidence of Gastrointestinal Adverse Events

Time frame:Baseline to Week 24 (monthly assessment)

event count, event

componentsNausea, Vomiting, Diarrhea

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

change in tacrolimus trough Level

Time frame:Monthly monitoring through Week 24

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.