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

Primary Purpose

Overweight or Obesity, CKD, Type 2 Diabetes

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LY3437943
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight or Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Institute for Liver Health dba Arizona Clinical Trials
  • Hope Clinical Research, Inc.Recruiting
  • Catalina Research Institute, LLCRecruiting
  • Peninsula Research AssociatesRecruiting
  • Suncoast Clinical Research, Inc.Recruiting
  • Prime Health and Wellness/SKYCRNG
  • Victorium Clinical Research - HoustonRecruiting
  • Endocrine Ips, PllcRecruiting
  • Tranquility Research
  • Circulate Cardiac & Vascular CentreRecruiting
  • North York Diagnostic and Cardiac CentreRecruiting
  • Stouffville Medical Centre
  • Dr. Anil K. Gupta Medicine Professional Corporation
  • Fadia El Boreky MedicineRecruiting
  • Viacar Recherche CliniqueRecruiting
  • 9109-0126 Quebec Inc.Recruiting
  • Centro Cardiologico Monzino
  • Azienda Ospedaliera Universitaria Pisana
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
  • Ospedale San Raffaele
  • Hospital Universitario Doctor Peset
  • Hospital Clinico de Valencia
  • Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
  • Vascular Research Team
  • North Middlesex Hospital
  • City Hospital, Nottingham University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LY3437943

Placebo

Arm Description

Participants will receive multiple doses of LY3437943 subcutaneously (SC)

Participants will receive LY3437943

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
June 30, 2023
Last Updated
October 5, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05936151
Brief Title
A Study of Retatrutide (LY3437943) on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Actual)
Primary Completion Date
November 25, 2025 (Anticipated)
Study Completion Date
November 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight or Obesity, CKD, Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Phase 2b
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LY3437943
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of LY3437943 subcutaneously (SC)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive LY3437943
Intervention Type
Drug
Intervention Name(s)
LY3437943
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Change from Baseline in Glomerular Filtration Rate (GFR)
Description
The GFR in milliliter/minute/square meter (mL/min/m²) using iohexol clearance (mGFR-measured glomerular filtration rate)
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Change from Baseline in Urine Albumin-to-Creatinine Ratio (UACR)
Time Frame
Baseline, Week 24
Title
Change from Baseline in Creatinine-Corrected Fractional Urinary Sodium Excretion (FENa)
Time Frame
Baseline, Week 24
Title
Change from Baseline in Filtration Fraction Estimated from Measured Glomerular Filtration Rate (mGFR)
Time Frame
Baseline, Week 24
Title
Change from Baseline Magnetic Resonance Imaging (MRI)
Description
MRI assessed renal mean arterial flow, corrected by hematocrit.
Time Frame
Baseline, Week 24
Title
Change from Baseline in in Mean Arterial Flow (MAF)
Time Frame
Baseline, Week 24
Title
Change from Baseline in Renal Artery Resistive Index (RARI)
Time Frame
Baseline, Week 24
Title
Change from Baseline in Renal Blood Flow Velocity Peak Systolic Velocity (PSV) and End-diastolic Velocity (ESV)
Time Frame
Baseline, Week 24
Title
Change from Baseline in Global Renal Perfusion (MRI)
Time Frame
Baseline, Week 24
Title
Change from Baseline in Total Renal Parenchyma Volume (MRI)
Time Frame
Baseline, Week 24
Title
Change from Baseline in Renal Cortex Volume (MRI)
Time Frame
Baseline, Week 24
Title
Change from Baseline in Renal Cortex T1 (ms) (MRI)
Time Frame
Baseline, Week 24
Title
Change from Baseline in Medulla T1 (ms) (MRI)
Time Frame
Baseline, Week 24
Title
Change from Baseline in Renal Cortex R2 (BOLD MRI)
Time Frame
Baseline, Week 24
Title
Change from Baseline in Medulla R2
Time Frame
Baseline, Week 24
Title
Change from Baseline in Body Weight
Time Frame
Baseline, Week 24
Title
Change from Baseline in 24-hr Urinary Albumin Excretion (UAE)
Time Frame
Baseline, Week 24
Title
Change from Baseline in Change in 24-hour (hr) Urinary Electrolytes (mg/24hr)
Time Frame
Baseline, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
The Institute for Liver Health dba Arizona Clinical Trials
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yessica Sachdeva
Facility Name
Hope Clinical Research, Inc.
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
818-999-4676
First Name & Middle Initial & Last Name & Degree
Hessam Aazami
Facility Name
Catalina Research Institute, LLC
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
909-590-8409
First Name & Middle Initial & Last Name & Degree
Rizwana H Mohseni
Facility Name
Peninsula Research Associates
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lawrence D Sher
Facility Name
Suncoast Clinical Research, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
727-849-4131
First Name & Middle Initial & Last Name & Degree
Visal Numrungroad
Facility Name
Prime Health and Wellness/SKYCRNG
City
Fayette
State/Province
Mississippi
ZIP/Postal Code
39069
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cinda Perryman, NP
Facility Name
Victorium Clinical Research - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ankur Arvind Doshi
Facility Name
Endocrine Ips, Pllc
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
713-973-3415
First Name & Middle Initial & Last Name & Degree
Amer S Al-Karadsheh
Facility Name
Tranquility Research
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
abdul abdellatif
Facility Name
Circulate Cardiac & Vascular Centre
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7M 1K9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Berlingieri
Facility Name
North York Diagnostic and Cardiac Centre
City
North York
State/Province
Ontario
ZIP/Postal Code
M6B 3H7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
4167830000
First Name & Middle Initial & Last Name & Degree
Subodh Verma
Facility Name
Stouffville Medical Centre
City
Stouffville
State/Province
Ontario
ZIP/Postal Code
L4A 1H2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas Wu
Facility Name
Dr. Anil K. Gupta Medicine Professional Corporation
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V 4B4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anil Gupta
Facility Name
Fadia El Boreky Medicine
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
5195697592
First Name & Middle Initial & Last Name & Degree
Fadia El Boreky
Facility Name
Viacar Recherche Clinique
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2G8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
4504657252
First Name & Middle Initial & Last Name & Degree
Raja RECHERCHES Chehayeb
Facility Name
9109-0126 Quebec Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4N 2W2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
5143366655
First Name & Middle Initial & Last Name & Degree
Ronald Akhras
Facility Name
Centro Cardiologico Monzino
City
Milan
State/Province
Milano
ZIP/Postal Code
20138
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
0258002815
First Name & Middle Initial & Last Name & Degree
Stefano Genovese
Facility Name
Azienda Ospedaliera Universitaria Pisana
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
39050993482
First Name & Middle Initial & Last Name & Degree
Anna Solini
Facility Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
390352678159
First Name & Middle Initial & Last Name & Degree
Roberto Trevisan
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
0226432819
First Name & Middle Initial & Last Name & Degree
Emanuela Setola
Facility Name
Hospital Universitario Doctor Peset
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
34648012408
First Name & Middle Initial & Last Name & Degree
Veronica Escudero
Facility Name
Hospital Clinico de Valencia
City
Valencia
State/Province
Valenciana
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Gorriz
Facility Name
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
City
Sevilla
ZIP/Postal Code
41003
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
34954709183
First Name & Middle Initial & Last Name & Degree
Alberto Aliaga Verdugo
Facility Name
Vascular Research Team
City
Salford
State/Province
Greater Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+44 161 2064122
First Name & Middle Initial & Last Name & Degree
Philip Kalra
Facility Name
North Middlesex Hospital
City
London
State/Province
London, City Of
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilary Tindall
Facility Name
City Hospital, Nottingham University Hospitals
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebekah Molyneux

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/

Learn more about this trial

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

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