Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

Phase 2

Recruiting

• Conditions: Heart Failure
• Interventions: Other: Placebo; Drug: BMS-986435

• Registration Number: NCT06122779
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-03
• Study First Submitted QC: 2023-11-03
• Study Start: 2023-11-07
• Study First Posted: 2023-11-08
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-16
• Last Update Posted: 2025-10-20
• Primary Completion: 2026-07-03
• Study Completion: 2026-07-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
BMS-986435	BMS-986435	-

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events (TEAEs)	Up to approximately 24 weeks
Incidence of serious adverse events (SAEs)	Up to approximately 24 weeks
Incidence of AEs leading to treatment discontinuation	Up to approximately 20 weeks

Secondary Outcome Measures

Name	Time	Method
Summary of plasma concentrations of MYK-224	Up to approximately 20 weeks

Trial Locations

Locations (117)

Ascension St. Vincent's Riverside Hospital - PPDS; 🇺🇸 Jacksonville, Florida, United States

Chicago Medical Research, LLC - Hazel Crest; 🇺🇸 Hazel Crest, Illinois, United States

University of Rochester Medical Center - PPDS; 🇺🇸 Rochester, New York, United States

Rochester General Hospital Center for Clinical Research; 🇺🇸 Rochester, New York, United States

Laurelton Heart Specialist PC - MyClinical - PPDS; 🇺🇸 Rosedale, New York, United States

Abington Memorial Hospital; 🇺🇸 Abington, Pennsylvania, United States

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

Chungnam National University Hospital; 🇰🇷 Daejeon, Daejeon Gwang'yeogsi, South Korea

Pusan National University Hospital; 🇰🇷 Busan, South Korea

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