Status:
COMPLETED
A Study of LY3461767 in Participants With Chronic Heart Failure With Reduced Ejection Fraction
Lead Sponsor:
Eli Lilly and Company
Conditions:
Chronic Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04840914
Start Date
June 1 2021
End Date
May 9 2024
Last Update
May 30 2024
Active Locations (7)
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1
Henry Ford Hospital
Detroit, Michigan, United States, 48202
2
Washington University
St Louis, Missouri, United States, 63110
3
University of North Carolina, Division of Cardiology
Chapel Hill, North Carolina, United States, 27599
4
Tsuchiura Kyodo Hospital
Tsuchiura, Ibaraki, Japan, 300-0053