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 (TREASURE-CKD) - I8F-MC-GPIG

Eli Lilly0 个研究点目标入组 16 人开始时间: 待定最近更新: 2024年4月9日

研究概览

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•1. Participants without diabetes must have HbA1c of <= 6.5 %.
•2. Participants with diabetes must have HbA1c >= 7 % to <= 10.5 % at screening
•3. Participants must be at least 18 years of age or the legal age of consent in
•the jurisdiction where the study is taking place.
•4. Participants must have a BMI >= 27kg/cm2 at screening visit.
•5. Participants must be diagnosed with CKD having a eGFR >=30 to <= 60 mL/min1.73
•m2 or eGFR >= 30 to 75 mL/min/1.73 m2 if UACR > 30 mg/g, calculated by CKD-EPI
•equation, as determined by central labs at screening visit.
•6. Participants must have been receiving an ACE or ARBi that is considered the
•maximal appropriate dose by the investigator for treatment of CKD or
•hypertension (unless patient has low blood pressure or hypotension). The dose
•must have been unchanged for 30 days before screening visit.

•For participants with T2D the following exclusion criteria apply:
•1. Participants have a history of proliferative diabetic retinopathy or
•diabetic macular edema or non-proliferative edema or non-proliferative diabetic
•retinopathy that requires acute treatment.
•2. Participants who have uncontrolled diabetes (such as diabetic ketoacidosis)
•at screening or randomization, in the judgement of the physician.
•For participants without T2D the following exclusion criteria apply:
•3. Have T1DM or a history of ketoacidosis ot hypersmolar state/coma
•4. Have self reported change in body weight >5kgs within the 90 days prior to
•screening visit
•5. Have had or plan to have surgical treatment for obesity (excluding
•liposuction or abdominoplasty if performed >1 year prior to screening)
•6. Have or plan to have endoscopic and or device based therapy for obesity or
•have had device removal within the last 180 days e.g. mucosal ablation, gastric
•artery embolization, intragastric balloon and duodenal jejunal bypass device.
•7. Have eGFr < 30 mL/min/1.73 m2 calculated by CKD-EPI equation.
•8. Have a history of unstable or rapidly progressing renal disease according to
•investigator judgement.
•9. Have a history of a congenital or hereditary kidney disease, like polycystic
•kidney disease or congenital urinary tract malformations

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