Clinical trial NCT06793371: AMBER-HFpEF: Assessment of CK-4021586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Symptomatic Heart Failure With Preserved Ejection Fraction (HFpEF)
Keywords: Symptomatic heart failure with preserved ejection fraction
HFpEF
Heart failure
CK-4021586
CK-586
AMBER-HFpEF
AMBER
Cardiac myosin inhibitor
CMI
CY 9021
Lead sponsor: Cytokinetics
Sponsor class: INDUSTRY
First posted: 2025-01-27
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of early drug discontinuation
timeFrame: 12 weeks
measure: Incidence of LVEF < 40%
timeFrame: 12 weeks
measure: Incidence of AEs
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in NT-proBNP
timeFrame: Baseline to Week 6 and Week 12
measure: Plasma concentrations of CK-4021586
timeFrame: 12 weeks
measure: Concentration-response relationship of CK-4021586 on NT-proBNP change
timeFrame: Baseline to Week 12
measure: Concentration-response relationship of CK-4021586 to LVEF change
timeFrame: Baseline to Week 12
measure: Change in LVEF
timeFrame: Baseline to Week 6 and Week 12
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: Eastern Shore Research Institute, LLC
state: Alabama
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Cincinnati
country: United States
facility: The Lindner Center for Research & Education at The Christ Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center, Dallas
state: Texas
Study officials:
affiliation: Cytokinetics
name: Cytokinetics MD
role: STUDY_DIRECTOR
References: