A Study of Retatrutide (LY3437943) on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05936151

Collaborator

(none)

120

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to investigate the effect of retatrutide on renal function in participants with overweight or obesity and chronic kidney disease (CKD), with or without Type 2 Diabetes (T2D). The study will lasts around 31 weeks.

Condition or Disease	Intervention/Treatment	Phase
Overweight or Obesity CKD Type 2 Diabetes	Drug: LY3437943 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Phase 2b

Primary Purpose:

Treatment

Official Title:

A Phase 2b, Double-Blind Study to Investigate the Effect of LY3437943 on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes

Anticipated Study Start Date :

Jul 17, 2023

Anticipated Primary Completion Date :

Feb 14, 2025

Anticipated Study Completion Date :

Feb 14, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3437943 Participants will receive multiple doses of LY3437943 subcutaneously (SC)	Drug: LY3437943 Administered SC
Placebo Comparator: Placebo Participants will receive LY3437943	Drug: Placebo Administered SC

Arm

Intervention/Treatment

Experimental: LY3437943

Participants will receive multiple doses of LY3437943 subcutaneously (SC)

Drug: LY3437943

Administered SC

Placebo Comparator: Placebo

Participants will receive LY3437943

Drug: Placebo

Administered SC

Outcome Measures

Primary Outcome Measures

Change from Baseline in Glomerular Filtration Rate (GFR) [Baseline, Week 24]
The GFR in milliliter/minute/square meter (mL/min/m²) using iohexol clearance (mGFR-measured glomerular filtration rate)

Secondary Outcome Measures

Change from Baseline in Urine Albumin-to-Creatinine Ratio (UACR) [Baseline, Week 24]
Change from Baseline in Creatinine-Corrected Fractional Urinary Sodium Excretion (FENa) [Baseline, Week 24]
Change from Baseline in Filtration Fraction Estimated from Measured Glomerular Filtration Rate (mGFR) [Baseline, Week 24]
Change from Baseline Magnetic Resonance Imaging (MRI) [Baseline, Week 24]
MRI assessed renal mean arterial flow, corrected by hematocrit.
Change from Baseline in in Mean Arterial Flow (MAF) [Baseline, Week 24]
Change from Baseline in Renal Artery Resistive Index (RARI) [Baseline, Week 24]
Change from Baseline in Renal Blood Flow Velocity Peak Systolic Velocity (PSV) and End-diastolic Velocity (ESV) [Baseline, Week 24]
Change from Baseline in Global Renal Perfusion (MRI) [Baseline, Week 24]
Change from Baseline in Total Renal Parenchyma Volume (MRI) [Baseline, Week 24]
Change from Baseline in Renal Cortex Volume (MRI) [Baseline, Week 24]
Change from Baseline in Renal Cortex T1 (ms) (MRI) [Baseline, Week 24]
Change from Baseline in Medulla T1 (ms) (MRI) [Baseline, Week 24]
Change from Baseline in Renal Cortex R2 (BOLD MRI) [Baseline, Week 24]
Change from Baseline in Medulla R2 [Baseline, Week 24]
Change from Baseline in Body Weight [Baseline, Week 24]
Change from Baseline in 24-hr Urinary Albumin Excretion (UAE) [Baseline, Week 24]
Change from Baseline in Change in 24-hour (hr) Urinary Electrolytes (mg/24hr) [Baseline, Week 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Have a body mass index (BMI) ≥27 kilogram/square meter (kg/m²)
Have either no T2D with an HbA1c <6.5% (<48 mmol/mol) or have T2D with an HbA1c
10.5% (≤91 mmol/mol), and treated with diet and exercise only with stable doses of up to 3 oral antihyperglycemic medications, with or without basal insulin.
Are on stable treatment, for at least 90 days before screening.
Have been diagnosed with chronic kidney disease (CKD).

Exclusion Criteria:

Have a self-reported change in body weight >5 kilogram (kg) (11 pounds) within 90 days before screening.
Have used in 90 days before the screening any of the following antihyperglycemic class: Dipeptidyl Peptidase IV (DPP4) inhibitors, amylin analogs, glucagon-like peptide-RA (GLP-RA), gastric inhibitory polypeptide (GIP)/GIP-1 RA, and short acting or rapid acting of U500 Insulins
Have a prior or planned surgical treatment for obesity
Have Type 1 Diabetes (T1D)
Have acute or chronic hepatitis
Have a history of malignant disease within 5 years before screening.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hope Clinical Research, Inc.	Canoga Park	California	United States	91303
2	Catalina Research Institute, LLC	Montclair	California	United States	91763
3	Peninsula Research Associates	Rolling Hills Estates	California	United States	90274
4	Suncoast Clinical Research, Inc.	New Port Richey	Florida	United States	34652
5	Great Lakes Clinical Trials - Ravenswood	Chicago	Illinois	United States	60640
6	Cleveland Clinic	Cleveland	Ohio	United States	44195
7	Victorium Clinical Research - Houston	Houston	Texas	United States	77024
8	Endocrine Ips, Pllc	Houston	Texas	United States	77079
9	Circulate Cardiac & Vascular Centre	Burlington	Ontario	Canada	L7M 1K9
10	North York Diagnostic and Cardiac Centre	North York	Ontario	Canada	M6B 3H7
11	Fadia El Boreky Medicine	Waterloo	Ontario	Canada	N2J 1C4
12	Viacar Recherche Clinique	Greenfield Park	Quebec	Canada	J4V 2G8
13	9109-0126 Quebec Inc.	Montreal	Quebec	Canada	H4N 2W2
14	Centro Cardiologico Monzino	Milan	Milano	Italy	20138
15	Azienda Ospedaliera Universitaria Pisana	Pisa	Toscana	Italy	56126
16	Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII	Bergamo		Italy	24127
17	Ospedale San Raffaele	Milano		Italy	20132
18	Hospital Universitario Doctor Peset	Valencia	Valenciana, Comunitat	Spain	46017
19	Hospital Clinico de Valencia	Valencia	Valenciana	Spain	46010
20	Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)	Sevilla		Spain	41003

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company