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

A Phase 2A, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06122779

Acronym

AURORA-HFpEF

Enrollment

227

Registered

2023-11-08

Start date

2023-11-07

Completion date

2026-12-14

Last updated

2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

BMS-986435, MYK-224, Pharmacokinetics, Pharmacodynamics, Safety, HFpEF

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).

Interventions

DRUGBMS-986435

Specified dose on specified days

OTHERPlacebo

Specified dose on specified days

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

Healthy volunteers

Inclusion criteria

\- Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability.

Exclusion criteria

* Participants must not have a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy or infiltrative/storage disorder such as cardiac amyloidosis, or any other acute or serious condition that could interfere with assessments during the study or may pose a risk to the participant. * Other protocol-defined Inclusion/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Summary of plasma concentrations of MYK-224	Up to approximately 20 weeks

Countries

Argentina, Canada, China, Israel, Italy, Japan, Poland, South Korea, Spain, United Kingdom, United States

Contacts

STUDY_DIRECTORBristol-Myers Squibb

Bristol-Myers Squibb

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026