Fact CheckerSign in

NCT04840914CompletedPhase 1

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

A Single-Dose Study Evaluating Different Dose Levels and Subcutaneous Infusion Durations on Safety, Pharmacokinetics, and Pharmacodynamics of LY3461767 in Participants With Chronic Heart Failure With Reduced Ejection Fraction

Source: ClinicalTrials.gov · Last updated 30 May 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
44 (actual)
First submitted
9 Apr 2021
Start date
1 Jun 2021
Primary completion date
9 May 2024
Lead sponsor
Eli Lilly and Company
NCT number
NCT04840914

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 44
  • From 1 Jun 2021 to the primary completion date, 9 May 2024
  • 7 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Have cardiac amyloidosis, accumulation diseases (e.g., haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic cardiomyopathy, pericardial constriction, or complex congenital heart disease.
  • Have a history or presence of hepatic, pancreatic, or biliary tract disorders
  • Have a history of malignancy or active malignancy at screening.

Age

  • Have not had age-appropriate cancer screening as recommended by the American Cancer Society and per medical judgment

Other

  • Have any moderate-to-severe stenosis of the mitral and/or aortic valve or moderate-to severe or greater mitral and/or aortic regurgitation.

Who the study is looking for

  • 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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The University of Tokyo Hospital
Coordinator of this site? Confirm its status
Bunkyō-KuJapanUnknown status
Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center
Coordinator of this site? Confirm its status
Kanazawa Ward,YokohamaJapanUnknown status
National Cerebral and Cardiovascular Center
Coordinator of this site? Confirm its status
Suita-ShiJapanUnknown status
Tsuchiura Kyodo Hospital
Coordinator of this site? Confirm its status
TsuchiuraJapanUnknown status
University of North Carolina, Division of Cardiology
Coordinator of this site? Confirm its status
Chapel HillUnited StatesUnknown status
Henry Ford Hospital
Coordinator of this site? Confirm its status
DetroitUnited StatesUnknown status
Washington University
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.