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

NCT04840914 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17518J2L-MC-EZBB
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 7

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.

Conditions

Chronic Heart Failure With Reduced Ejection Fraction

Keywords

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Predose up to 48 hours post end of infusion

• PK: Maximum Concentration (Cmax) of LY3461767

  Predose up to 48 hours post end of infusion

Study Arms (2)

LY3461767

EXPERIMENTAL

LY3461767 administered subcutaneously (SC).

Drug: LY3461767

Placebo

PLACEBO COMPARATOR

Placebo administered subcutaneously (SC).

Drug: Placebo

Interventions

LY3461767 DRUG

Administered SC.

LY3461767

Placebo DRUG

Administered SC.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (7)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of North Carolina, Division of Cardiology

Chapel Hill, North Carolina, 27599, United States

Location

Tsuchiura Kyodo Hospital

Tsuchiura, Ibaraki, 300-0053, Japan

Location

Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center

Kanazawa Ward,Yokohama, Kanagawa, 236-0051, Japan

Location

National Cerebral and Cardiovascular Center

Suita-shi, Osaka, 564-8565, Japan

Location

The University of Tokyo Hospital

Bunkyo-ku, Tokyo, 113-8655, Japan

Location

Related Links

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

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 12, 2021
• Study Start: June 1, 2021
• Primary Completion: May 9, 2024
• Study Completion: May 9, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (4); US (3)