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

Conditions

• Heart Failure

Eligibility Criteria

Sex

ALL

Age

40 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• BMS-986435 — DRUG
  Specified dose on specified days
• Placebo — OTHER
  Specified dose on specified days

Study Details

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).

Key Dates

Start date

Nov 7, 2023

Status verified

May 2026

Primary completion

Jul 3, 2026

Completion

Jul 3, 2026

Study Design

Enrollment

208 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: BMS-986435
• Placebo Comparator: Placebo

Primary Outcome Measure

Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: Up to approximately 24 weeks ]

Central Contacts

• BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  855-907-3286
  [email protected]
• First line of the email MUST contain NCT # and Site #.

Locations (31)

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