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.

View Eligibility Criteria

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 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

Study is for people with:

Heart Failure

Phase:

Phase 1

Estimated Enrollment:

44

Study ID:

NCT04840914

Recruitment Status:

Completed

Sponsor:

Eli Lilly and Company

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There are 7 Locations for this study

See Locations Near You

Henry Ford Hospital
Detroit Michigan, 48202, United States
Washington University
Saint Louis Missouri, 63110, United States
University of North Carolina, Division of Cardiology
Chapel Hill North Carolina, 27599, United States
Tsuchiura Kyodo Hospital
Tsuchiura Ibaraki, 300-0, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center
Kanazawa Ward,Yokohama Kanagawa, 236-0, Japan
National Cerebral and Cardiovascular Center
Suita-shi Osaka, 564-8, Japan
The University of Tokyo Hospital
Bunkyo-ku Tokyo, 113-8, Japan

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 1

Estimated Enrollment:

44

Study ID:

NCT04840914

Recruitment Status:

Completed

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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