A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney … (NCT05536804) | Clinical Trial Compass
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
United States140 participantsStarted 2023-02-08
Plain-language 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 56 weeks and include up to 12 visits.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Percent Change from Baseline in Renal Sinus Fat Content (MRI)