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

Who is this study for? Patients with Chronic Heart Failure With Reduced Ejection Fraction
What treatments are being studied? LY3461767
Status: Completed
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Michigan
Henry Ford Hospital
Detroit
Missouri
Washington University
Saint Louis
North Carolina
University of North Carolina, Division of Cardiology
Chapel Hill
Other Locations
Japan
The University of Tokyo Hospital
Bunkyo-ku
Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center
Kanazawa Ward,yokohama
National Cerebral and Cardiovascular Center
Suita-shi
Tsuchiura Kyodo Hospital
Tsuchiura
Time Frame
Start Date: 2021-06-01
Completion Date: 2024-05-09
Participants
Target number of participants: 44
Treatments
Experimental: LY3461767
LY3461767 administered subcutaneously (SC).
Placebo_comparator: Placebo
Placebo administered subcutaneously (SC).
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov