Heart Failure Clinical Trial
A Study of LY3461767 in Participants With Chronic Heart Failure With Reduced Ejection Fraction
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.
Eligibility 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 = 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
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There are 8 Locations for this study
Detroit Michigan, 48202, United States More Info
Principal Investigator
Saint Louis Missouri, 63110, United States More Info
Principal Investigator
Chapel Hill North Carolina, 27599, United States More Info
Principal Investigator
Norfolk Virginia, 23507, United States More Info
Principal Investigator
Tsuchiura Ibaraki, 300-0, Japan More Info
Principal Investigator
Kanazawa Ward,Yokohama Kanagawa, 236-0, Japan More Info
Principal Investigator
Suita-shi Osaka, 564-8, Japan More Info
Principal Investigator
Bunkyo-ku Tokyo, 113-8, Japan More Info
Principal Investigator
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