A Study of LY3461767 in Participants With Chronic Heart Failure With Reduced Ejection Fraction
Completed · Phase 1 · Has a placebo group
Conditions studied: Chronic Heart Failure With Reduced Ejection Fraction
In brief
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.
Key facts
- Study ID
- NCT04840914
- Run by
- Eli Lilly and Company
- People needed
- 44
- Starts
- 2021-06-01
- Expected to finish
- 2024-05-09
- Last updated by the study team
- 2024-05-30
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Henry Ford Hospital — Detroit, Michigan, United States
- Washington University — St Louis, Missouri, United States
- University of North Carolina, Division of Cardiology — Chapel Hill, North Carolina, United States
- Tsuchiura Kyodo Hospital — Tsuchiura, Ibaraki, Japan
- Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center — Kanazawa Ward,Yokohama, Kanagawa, Japan
- National Cerebral and Cardiovascular Center — Suita-shi, Osaka, Japan
- The University of Tokyo Hospital — Bunkyo-ku, Tokyo, Japan
Full record on ClinicalTrials.gov
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