AMBER-HFpEF: Assessment of CK-4021586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF

Purpose

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

Condition

  • Symptomatic Heart Failure With Preserved Ejection Fraction (HFpEF)

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