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

• Status: Recruiting
• Trial end date: 2023-02-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

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 < 40.0 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) ≥ 300 picograms per millilitre (pg/mL)

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