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A Study of LY3461767 in Participants With Chronic Heart Failure With Reduced Ejection Fraction

Primary Purpose

Chronic Heart Failure With Reduced Ejection Fraction

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LY3461767
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Heart Failure With Reduced Ejection Fraction focused on measuring Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Are males and in agreement to follow contraceptive requirements, or women of non-child-bearing potential
  • Have a body mass index (BMI) of </= 45.0 kilograms per square meter (kg/m²)
  • Have chronic stable heart failure (New York Heart Association (NYHA) classification II and III) on guideline directed heart failure therapy for at least 6 months prior to enrolment
  • Have not changed optimal guideline directed therapy in the last 1 month prior to screening, If treated with oral diuretics, dose must be stable for at least 2 weeks prior to screening
  • Have Left Ventricular Ejection Fraction (LVEF) < 40%
  • Have a record of N-terminal pro b-type natriuretic peptide (NT-ProBNP) ≥ 200 picograms per millilitre (pg/mL) or a BNP value of >/= 60 pg/mL within the past 12 months prior to screening

Exclusion Criteria:

  • Have myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke in the last 90 days prior to screening
  • Have acute decompensated heart failure requiring IV diuretics within 12 weeks prior to screening
  • Have cardiac amyloidosis, accumulation diseases (e.g., haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic cardiomyopathy, pericardial constriction, or complex congenital heart disease.
  • Have any moderate-to-severe stenosis of the mitral and/or aortic valve or moderate-to severe or greater mitral and/or aortic regurgitation.
  • Have a history or presence of hepatic, pancreatic, or biliary tract disorders
  • Have a history of malignancy or active malignancy at screening.
  • Have not had age-appropriate cancer screening as recommended by the American Cancer Society and per medical judgment

Sites / Locations

  • Henry Ford HospitalRecruiting
  • Washington UniversityRecruiting
  • University of North Carolina, Division of CardiologyRecruiting
  • Tsuchiura Kyodo HospitalRecruiting
  • Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory CenterRecruiting
  • National Cerebral and Cardiovascular CenterRecruiting
  • The University of Tokyo HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LY3461767

Placebo

Arm Description

LY3461767 administered subcutaneously (SC).

Placebo administered subcutaneously (SC).

Outcomes

Primary Outcome Measures

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3461767
PK: AUC of LY3461767
PK: Maximum Concentration (Cmax) of LY3461767
PK: Cmax of LY3461767

Full Information

First Posted
April 9, 2021
Last Updated
October 19, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04840914
Brief Title
A Study of LY3461767 in Participants With Chronic Heart Failure With Reduced Ejection Fraction
Official Title
A Single-Dose Study Evaluating Different Dose Levels and Subcutaneous Infusion Durations on Safety, Pharmacokinetics, and Pharmacodynamics of LY3461767 in Participants With Chronic Heart Failure With Reduced Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
March 21, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of this study is to determine the tolerability and safety of LY3461767 with any side effects that might be associated with it. Study drug will be provided in a continuous subcutaneous infusion lasting 24 hours to 96 hours, depending on the cohort. Blood tests will be performed to check concentrations of LY3461767 in the bloodstream and how long it takes the body to get rid of it in participants with chronic heart failure with reduced ejection fraction (HFrEF). The study will last up to 3 months and may include 5 visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure With Reduced Ejection Fraction
Keywords
Heart Failure

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LY3461767
Arm Type
Experimental
Arm Description
LY3461767 administered subcutaneously (SC).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered subcutaneously (SC).
Intervention Type
Drug
Intervention Name(s)
LY3461767
Intervention Description
Administered SC.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC.
Primary Outcome Measure Information:
Title
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Description
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time Frame
Baseline through Day 90
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3461767
Description
PK: AUC of LY3461767
Time Frame
Predose up to 48 hours post end of infusion
Title
PK: Maximum Concentration (Cmax) of LY3461767
Description
PK: Cmax of LY3461767
Time Frame
Predose up to 48 hours post end of infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Are males and in agreement to follow contraceptive requirements, or women of non-child-bearing potential Have a body mass index (BMI) of </= 45.0 kilograms per square meter (kg/m²) Have chronic stable heart failure (New York Heart Association (NYHA) classification II and III) on guideline directed heart failure therapy for at least 6 months prior to enrolment Have not changed optimal guideline directed therapy in the last 1 month prior to screening, If treated with oral diuretics, dose must be stable for at least 2 weeks prior to screening Have Left Ventricular Ejection Fraction (LVEF) < 40% Have a record of N-terminal pro b-type natriuretic peptide (NT-ProBNP) ≥ 200 picograms per millilitre (pg/mL) or a BNP value of >/= 60 pg/mL within the past 12 months prior to screening Exclusion Criteria: Have myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke in the last 90 days prior to screening Have acute decompensated heart failure requiring IV diuretics within 12 weeks prior to screening Have cardiac amyloidosis, accumulation diseases (e.g., haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic cardiomyopathy, pericardial constriction, or complex congenital heart disease. Have any moderate-to-severe stenosis of the mitral and/or aortic valve or moderate-to severe or greater mitral and/or aortic regurgitation. Have a history or presence of hepatic, pancreatic, or biliary tract disorders Have a history of malignancy or active malignancy at screening. Have not had age-appropriate cancer screening as recommended by the American Cancer Society and per medical judgment
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
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
313-916-6375
First Name & Middle Initial & Last Name & Degree
David Lanfear
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
314-454-7009
First Name & Middle Initial & Last Name & Degree
Gregory Ewald
Facility Name
University of North Carolina, Division of Cardiology
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
919-843-5223
First Name & Middle Initial & Last Name & Degree
Kirkwood F Adams
Facility Name
Tsuchiura Kyodo Hospital
City
Tsuchiura
State/Province
Ibaraki
ZIP/Postal Code
300-0053
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81298303711
First Name & Middle Initial & Last Name & Degree
Tsunekazu Kakuta
Facility Name
Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center
City
Kanazawa Ward,Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81457019581
First Name & Middle Initial & Last Name & Degree
Kazuki Fukui
Facility Name
National Cerebral and Cardiovascular Center
City
Suita
State/Province
Osaka
ZIP/Postal Code
564-8565
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81661701070
First Name & Middle Initial & Last Name & Degree
Chisato Izumi
Facility Name
The University of Tokyo Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81338155411
First Name & Middle Initial & Last Name & Degree
Tatsuya Maruyama

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/1W0ItmrE6ruLINUYr7X1m5
Description
A Study of LY3461767 in Participants With Chronic Heart Failure With Reduced Ejection Fraction

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A Study of LY3461767 in Participants With Chronic Heart Failure With Reduced Ejection Fraction

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