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

ConditionSymptomatic Heart Failure With Preserved Ejection Fraction (HFpEF)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-85
SponsorCytokinetics

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)

    Drug

    CK-4021586 administered orally

  • Placebo to match CK-4021586

    Drug

    Placebo administered orally

Treatment groups

60 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: CK-4021586 - Cohort 1Experimental treatment 1 intervention
Group B: Placebo - Cohort 1Placebo comparator 1 intervention
Group C: CK-4021586 - Cohort 2Experimental treatment 1 intervention
Group D: Placebo - Cohort 2Placebo comparator 1 intervention
Group E: CK-4021586 - Cohort 3Experimental treatment 1 intervention
Group F: Placebo - Cohort 3Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of early drug discontinuation

Incidence of early drug discontinuation observed during dosing of CK 4021586 in patients with HFpEF

Time frame
12 weeks
2

Incidence of LVEF < 40%

Incidence of left-ventricular ejection fraction (LVEF) \< 40% observed during dosing of CK-4021586 in patients with HFpEF

Time frame
12 weeks
3

Incidence of AEs

Incidence of adverse events observed during dosing of CK-4021586 in patients with HFpEF

Time frame
12 weeks

Secondary outcomes

1

Change in NT-proBNP

Change from baseline values in NT-proBNP to Week 6 and Week 12

Time frame
Baseline to Week 6 and Week 12
2

Plasma concentrations of CK-4021586

Observed 2-hour post dose plasma concentration (C2hr) and minimum plasma concentration (Cmin) for CK-4021586 over the dosing interval

Time frame
12 weeks
3

Concentration-response relationship of CK-4021586 on NT-proBNP change

Slope of the relationship of plasma concentration of CK-4021586 to the change from baseline in the NT-proBNP

Time frame
Baseline to Week 12
4

Concentration-response relationship of CK-4021586 to LVEF change

Slope of the relationship of plasma concentration of CK-4021586 to the change from baseline in the LVEF

Time frame
Baseline to Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cytokinetics

Lead sponsor

Source ClinicalTrials.gov
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