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Active, Not Recruiting

NCT Number: NCT05536804

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

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 56 weeks and include up to 12 visits.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Overweight Body Weight Chronic Disease Chronic Kidney Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms T2D Type 2 Diabetes Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Klinik Hietzing, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tirzepatide

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

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

    Time frame: Baseline, Week 52

Secondary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 52

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

    Time frame: Baseline, Week 52

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

    Time frame: Baseline, Week 52

  4. Change from Baseline in Apparent Diffusion Coefficient (ADC) MRI

    Time frame: Baseline, Week 52

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

    Time frame: Baseline, Week 52

  6. Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Baseline, Week 52

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

    Time frame: Baseline, Week 52

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

    Time frame: Baseline, Week 52

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Acronym: TREASURE-CKD

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 13, 2022
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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