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Purpose

This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.

Condition

Eligibility

Eligible Ages
Between 40 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Males and females ≥ 40 years and ≤ 85 years of age at screening. - Diagnosed with HF with NYHA functional class II or III. - Screening echocardiography with LVEF ≥ 60%. - Screening NT-proBNP ≥ 300 pg/mL for participants in sinus rhythm and ≥ 900 pg/mL for participants with comorbid atrial fibrillation or flutter. - Body mass index < 40 kg/m2. - Participants on beta-blockers, angiotensin-converting enzyme (ACE)/angiotensin II receptor blocker (ARB) or angiotensin receptor/neprilysin inhibitor (ARNI), or sodium-glucose contransporter-2 (SGLT2)-inhibitors must be on stable doses for more than 4 weeks prior to screening. - Participants on a glucagon-like peptide-1 (GLP-1) agonist must be on a stable dose for more than 24 weeks prior to screening with no anticipated plans to change dose during this study.

Exclusion Criteria

  • History or evidence of any other clinically significant disorder, malignancy, active infection, other condition, or disease that, in the opinion of the investigator or the Medical Monitor, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CK-4021586 - Cohort 1 		Participants may receive 150 mg or 300 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total.
  • Drug: CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)
    CK-4021586 administered orally
Placebo Comparator
Placebo - Cohort 1 		Participants will receive placebo daily for up to 12 weeks.
  • Drug: Placebo to match CK-4021586
    Placebo administered orally
Experimental
CK-4021586 - Cohort 2 		Participants may receive 300 mg or 450 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total.
  • Drug: CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)
    CK-4021586 administered orally
Placebo Comparator
Placebo - Cohort 2 		Participants will receive placebo daily for up to 12 weeks.
  • Drug: Placebo to match CK-4021586
    Placebo administered orally
Experimental
CK-4021586 - Cohort 3 		Participants may receive 450 mg or 600 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total.
  • Drug: CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)
    CK-4021586 administered orally
Placebo Comparator
Placebo - Cohort 3 		Participants will receive placebo daily for up to 12 weeks.
  • Drug: Placebo to match CK-4021586
    Placebo administered orally

Recruiting Locations

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02214

More Details

Status
Recruiting
Sponsor
Cytokinetics

Study Contact

Cytokinetics MD
650-624-2929
medicalaffairs@cytokinetics.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.