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

JRCT ID: jRCT2031210456

Registered date:26/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic Heart Failure With Reduced Ejection Fraction
• Date of first enrollment: 13/12/2021
• Target sample size: 13
• Countries of recruitment: The United States of America,Japan
• Study type: Interventional

Intervention(s)

Drug: LY3461767
Administered SC.
Drug: Placebo
Administered SC.

Experimental: LY3461767
LY3461767 administered subcutaneously (SC).
Placebo Comparator: Placebo
Placebo administered subcutaneously (SC).

Outcome(s)

• Primary Outcome: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

- Are males and in agreement to 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 LVEF <40% measured quantitatively using ECHO, computed tomography angiogram, or cardiac magnetic resonance imaging in an historical imaging assessment performed within 12 months prior to screening, as well as by ECHO at screening as determined by the central ECHO laboratory. From Cohort 4, Japanese participants with LVEF between 40 and <50% at screening and/or in historical imaging assessment may be included in the Cohort after the first 6 participants are enrolled
- Have a record of NT-proBNP >=200 pg/mL or a BNP value of >60 pg/mL within the past 12 months prior to screening. Japanese participants will be exempt from this criterion if their LVEF is <40% at both screening and in historical imaging assessment. Participants with LVEF between 40 and <50% at either screening or in historical imaging assessment must meet NT-proBNP >=200 pg/mL or a BNP value of >60 pg/mL within the past 12 months prior to screening

Exclude 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.

Related Information

• Primary Sponsor: Wakayama Naohiko
• Secondary ID(s): NCT04840914