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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-05-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Heart Failure With Reduced Ejection Fraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3461767

LY3461767 administered subcutaneously (SC).

Group Type EXPERIMENTAL

LY3461767

Intervention Type DRUG

Administered SC.

Placebo

Placebo administered subcutaneously (SC).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC.

Interventions

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LY3461767

Administered SC.

Intervention Type DRUG

Placebo

Administered SC.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No