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

Lilly

Status and phase: Completed; Phase 1

Conditions: Chronic Heart Failure With Reduced Ejection Fraction

Treatments: Drug: Placebo; Drug: LY3461767

Study type: Interventional

Funder types: Industry

Identifiers

NCT04840914

J2L-MC-EZBB (Other Identifier)

17518

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

44 participants in 2 patient groups, including a placebo group

LY3461767

Experimental group

Description:

LY3461767 administered subcutaneously (SC).

Treatment:

Drug: LY3461767

Placebo

Placebo Comparator group

Description:

Placebo administered subcutaneously (SC).

Treatment:

Drug: Placebo