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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05536804
Recruitment Status : Recruiting
First Posted : September 13, 2022
Last Update Posted : May 24, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:

We are doing this study to learn more about how tirzepatide may help fight chronic kidney disease in people with obesity with or without type 2 diabetes (T2D).

The study will last about 1 year.


Condition or disease Intervention/treatment Phase
Overweight Obesity Chronic Kidney Disease Type 2 Diabetes T2D Drug: Tirzepatide Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 8, 2023
Estimated Primary Completion Date : October 10, 2025
Estimated Study Completion Date : November 7, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Tirzepatide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tirzepatide
Tirzepatide administered subcutaneously (SC)
 Drug: Tirzepatide
Administered SC
Placebo Comparator: Placebo
Placebo administered SC
 Drug: Placebo
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in Kidney Oxygenation in Participants With or Without T2D [ Time Frame: Baseline, Week 52 ]
    Blood oxygenation-level dependent magnetic resonance imaging (BOLD MRI)


Secondary Outcome Measures :
  1. Change from Baseline in Kidney Oxygenation in Participants with T2D (BOLD MRI) [ Time Frame: Baseline, Week 52 ]
  2. Change from Baseline in Kidney Oxygenation in Participants without T2D (BOLD MRI) [ Time Frame: Baseline, Week 52 ]
  3. Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 52 ]
  4. Percent Change from Baseline in Renal Sinus Fat Content (MRI) [ Time Frame: Baseline, Week 52 ]
  5. Percent Change from Baseline in Renal Fat Content (MRI Proton Density Fat Fraction) [ Time Frame: Baseline, Week 52 ]
  6. Percent Change from Baseline in Renal Blood Flow (Phase-Contrast MRI) [ Time Frame: Baseline, Week 52 ]
  7. Change from Baseline in Apparent Diffusion Coefficient (ADC) MRI [ Time Frame: Baseline, Week 52 ]
  8. Change from Baseline in Glomerular Filtration Rate (GFR) Iohexol Clearance in Milliliter/Minute/Square Meter (ml/min/m²) [ Time Frame: Baseline, Week 52 ]
  9. Change from Baseline in 24-hour Urinary Albumin Excretion (UAE) in Milligram/24 Hours (mg/24h) [ Time Frame: Baseline, Week 52 ]
  10. Percent Change from Baseline in Urine Albumin-to-Creatine Ratio (UACR) [ Time Frame: Baseline, Week 52 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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) ≥30 to ≤60 ml/min/1.73 m² or eGFR ≥30 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 ≥7.0% to ≤10.5% 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 <30 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05536804


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05536804    
Other Study ID Numbers: 17217
I8F-MC-GPIG ( Other Identifier: Eli Lilly and Company )
2021-005273-47 ( EudraCT Number )
First Posted: September 13, 2022    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tirzepatide
Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Urologic Diseases
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists