Tirzepatide Mechanism of Action Study on Renal Function (TREASURE-CKD)

Phase 1

Conditions: Obesity and Chronic Kidney disease
MedDRA version: 20.0Level: SOCClassification code 10038359Term: Renal and urinary disordersSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0Level: SOCClassification code 10027433Term: Metabolism and nutrition disordersSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2021-005273-47-NL

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 140

Inclusion Criteria

1.Participants without diabetes must have HbA1c of = 6.5 %.
2.Participants with diabetes must have HbA1c = 7 % to = 10.5 % at screening visit.
3.Participants must be at least 18 years of age or the legal age of consent in the juristiction 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 eqn., 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effect of tirzepatide MTD (10 or 15 mg) QW and placebo on kidney oxygenation after 52 weeks of treatment, in participants with and without T2D;Secondary Objective: To compare the effect of tirzepatide MTD (10 or 15 mg) QW and placebo after 52 weeks of treatment, in participants with and without T2D, in participants with T2D, and in participants without T2D on:<br>- body weight ? Mean percent change from baseline in body weight<br>- renal sinus fat ? Mean change from baseline in renal sinus fat (cm2) assessed using MRI<br>- renal fat content ? Mean change from baseline in renal fat content using MRI-PDFF<br>- renal blood flow;Primary end point(s): Mean change from baseline in kidney oxygenation;Timepoint(s) of evaluation of this end point: 52 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Mean percent change from baseline in body weight<br>Mean change from baseline in renal sinus fat (cm2) assessed using MRI<br>Mean change from baseline in renal fat content using MRI-PDFF<br>Mean change from baseline in renal blood flow using phase-contrast MRI;Timepoint(s) of evaluation of this end point: 52 weeks

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