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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)
EU CTIS ID: 2023-506082-60-00
What this study is testing
To compare the effect of tirzepatide MTD (10 or 15 mg) QW and placebo after 52 weeks of treatment, on renal sinus fat
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- All participants with or without diabetes: Have a Body Mass Index (BMI) ≥27 kilogram/square meter (kg/m²) at screening
- All participants with or without diabetes: Diagnosed with chronic kidney disease (CKD)
- All participants with or without diabetes: 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)
- All participants with or without diabetes: 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
You likely can't join if
- 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)
See the full eligibility criteria
- All participants with or without diabetes: Have a Body Mass Index (BMI) ≥27 kilogram/square meter (kg/m²) at screening
- All participants with or without diabetes: Diagnosed with chronic kidney disease (CKD)
- All participants with or without diabetes: 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)
- All participants with or without diabetes: 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
- Participants with Type 2 diabetes: Have HbA1c ≤9.5% at screening
- 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.
- Participants with T2D: Have been diagnosed with type 1 diabetes (T1D) or have history of ketoacidosis or hyperosmolar state/coma
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Mexico
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Mexico; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.