Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT06122779
NCT06122779Active, not recruitingPhase 2

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)

Bristol-Myers Squibb282 sites in 4 countries227 target enrollmentStarted: November 7, 2023Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Active, not recruiting
Enrollment
227
Locations
282
Primary Endpoint
Incidence of treatment emergent adverse events (TEAEs)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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/Exclusion criteria apply.

Arms & Interventions

BMS-986435

Experimental

Intervention: BMS-986435 (Drug)

Placebo

Placebo Comparator

Intervention: Placebo (Other)

Outcomes

Primary Outcomes

Incidence of treatment emergent adverse events (TEAEs)

Time Frame: Up to approximately 24 weeks

Incidence of serious adverse events (SAEs)

Time Frame: Up to approximately 24 weeks

Incidence of AEs leading to treatment discontinuation

Time Frame: Up to approximately 20 weeks

Secondary Outcomes

  • Summary of plasma concentrations of MYK-224(Up to approximately 20 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (282)

Loading locations...

Similar Trials

Completed
Phase 1
A Study Investigating the Safety, Tolerability, Drug Levels and Drug Effect of BMS-986278 in Healthy Adult Participants (Part 1) and Japanese Participants (Part 2)Healthy Participants
NCT05684289Bristol-Myers Squibb61
Completed
Not Applicable
Study Evaluating the Safety and TolerabilityHealthy Volunteers
NCT04692506BioGaia AB36
Completed
Phase 2
A Dose-Ranging Study of the Safety and Effectiveness of MK-8237 in the Treatment of House Dust Mite (HDM) Induced Allergic Rhinitis/Rhinoconjunctivitis in Adults (MK-8237-003/P07627)Rhinitis, Allergic, PerennialRhinitis, Allergic, Nonseasonal
NCT01644617ALK-Abelló A/S124
Completed
Phase 2
Study of AOBO-001 for Overactive Bladder With Urge Urinary Incontinence and FrequencyOveractive Bladder
NCT01294982American Oriental Bioengineering, Inc.66
Terminated
Phase 2
Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis SuppurativaHidradenitis Suppurativa
NCT01838499AstraZeneca224