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TREASURE-CKD

Active not recruitingPhase 2

A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes

Tirzepatide Study of Renal Function in People With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes: Focus on Kidney Hypoxia in Relation to Fatty Kidney Disease Using Multiparametric Magnetic Resonance Imaging

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

27

Recruiting sites

Enrollment

140

estimated

Study population

Chronic kidney disease, Obesity / overweight

Key I/E criteria

BMI ≥27HbA1c ≤6.5%eGFR 25-60UACR ≥30

Primary endpoint

Renal Sinus Fat Content (MRI)

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 IDNCT05536804
Org study ID17217
Secondary ID2021-005273-47
Secondary ID2023-506082-60-00EU Trial Number
Secondary IDI8F-MC-GPIGEli Lilly and Company

Timeline

Milestones

Study first posted2022-09-13actual
Study start2023-02-08actual
Last update posted2026-05-08actual
Primary completion2026-09estimated (month precision)
Study completion2026-10estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Chronic kidney diseaseObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

All participants with or without diabetes:

Have a Body Mass Index (BMI) ≥27 kilogram/square meter (kg/m²) at screening
Diagnosed with chronic kidney disease (CKD)
Has an estimated glomerular filtration rate (eGFR) ≥25 to ≤60 ml/min/1.73 m² or eGFR ≥25 to ≤75 ml/min/1.73 m² if urine albumin-to-creatinine ratio (UACR) >30 milligram/gram (mg/g)
Have been receiving an angiotensin-converting enzyme (ACE) or angiotensin II receptor blockers (ARB) that is considered the maximal appropriate dose by the investigator for treatment of chronic kidney disease or hypertension (unless the participant has low blood pressure or hypotension)

Participants without diabetes:

Have Hemoglobin A1c (HbA1c) <6.5% at screening

Participants with Type 2 diabetes:

Have been diagnosed at least 180 days prior to screening
Have HbA1c ≤9.5% at screening

Exclusion criteria

All participants:

Have a self-reported change in body weight >5 kilogram (kg) within 90 days prior to screening.
Have a prior or planned surgical treatment for obesity
Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 180 days
Have eGFR <25 mL/min/1.73m² calculated by using creatinine-based chronic kidney disease epidemiology collaboration (CKD-EPI) equations, as determined by central laboratory at screening.
Have a history of unstable or rapidly progressing renal disease according to investigator judgment
Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility)
Have had a history of chronic or acute pancreatitis

Participants with T2D:

Have history of proliferative diabetic retinopathy or diabetic macular edema or non-proliferative diabetic retinopathy that requires acute treatment.
Have been diagnosed with type 1 diabetes (T1D) or have history of ketoacidosis or hyperosmolar state/coma

Endpoints (9)

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

Renal / kidney
5
Weight & body composition
2
MASH / liver
1
Other (unclassified)
1

Weight & body composition

2 endpoints
Primary/protocol endpoint

Percent Change from Baseline in Renal Sinus Fat Content (MRI)

Time frame:Baseline, Week 52

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 52

Body weight, % change

percent change from baseline, improvement

MASH / liver

1 endpoint
Secondary/protocol endpoint/low confidence

Percent Change from Baseline in Renal Fat Content (MRI Proton Density Fat Fraction)

Time frame:Baseline, Week 52

percent change from baseline, improvement

Renal / kidney

5 endpoints
Secondary/protocol endpoint

Percent Change from Baseline in Renal Blood Flow (Phase-Contrast MRI)

Time frame:Baseline, Week 52

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Glomerular Filtration Rate (GFR) Iohexol Clearance in Milliliter/Minute/Square Meter (ml/min/m²)

Time frame:Baseline, Week 52

eGFR, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)

Time frame:Baseline, Week 52

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Change from Baseline in 24-hour Urinary Albumin Excretion (UAE) in Milligram/24 Hours (mg/24h)

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Urine Albumin-to-Creatine Ratio (UACR) in Participants With Baseline ≥30 mg/g

Time frame:Baseline, Week 52

uACR, % change

percent change from baseline, improvement

LOINC 9318-7

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change from Baseline in Apparent Diffusion Coefficient (ADC) MRI

Time frame:Baseline, Week 52

change from baseline, descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.