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

  • STATUS
    Recruiting
  • End date
    Feb 10, 2023
  • participants needed
    50
  • sponsor
    Eli Lilly and Company
Updated on 12 September 2021

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.

Details
Condition Chronic Heart Failure With Reduced Ejection Fraction
Treatment Placebo, LY3461767
Clinical Study IdentifierNCT04840914
SponsorEli Lilly and Company
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

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/m)
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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