RecruitingPhase 2NCT06793371
AMBER-HFpEF: Assessment of CK-4021586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-4021586 in Adults With Symptomatic Heart Failure With Preserved Ejection Fraction
Sponsor
Cytokinetics
Enrollment
60 participants
Start Date
Feb 6, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.
Eligibility
Min Age: 40 YearsMax Age: 85 Years
Inclusion Criteria7
- 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), must be on stable doses for more than 30 days 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 Criteria1
- 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.
Interventions
DRUGCK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)
CK-4021586 administered orally
DRUGPlacebo to match CK-4021586
Placebo administered orally
Locations(24)
View Full Details on ClinicalTrials.gov
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NCT06793371