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

Chronic Heart Failure With Reduced Ejection Fraction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04840914
• Other study ID #: 17518
• Secondary ID: J2L-MC-EZBB
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2021
• Est. completion date: May 9, 2024

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 9, 2024
• Est. primary completion date: May 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure With Reduced Ejection Fraction
• Heart Failure

Intervention

Drug:
• LY3461767
Administered SC.
• Placebo
Administered SC.

Locations

Country	Name	City	State
Japan	The University of Tokyo Hospital	Bunkyo-ku	Tokyo
Japan	Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center	Kanazawa Ward,Yokohama	Kanagawa
Japan	National Cerebral and Cardiovascular Center	Suita-shi	Osaka
Japan	Tsuchiura Kyodo Hospital	Tsuchiura	Ibaraki
United States	University of North Carolina, Division of Cardiology	Chapel Hill	North Carolina
United States	Henry Ford Hospital	Detroit	Michigan
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline through Day 90
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3461767	PK: AUC of LY3461767	Predose up to 48 hours post end of infusion
Secondary	PK: Maximum Concentration (Cmax) of LY3461767	PK: Cmax of LY3461767	Predose up to 48 hours post end of infusion

External Links

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