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

Cytokinetics

Status and phase: Enrolling; Phase 2

Conditions: Symptomatic Heart Failure With Preserved Ejection Fraction (HFpEF)

Treatments: Drug: CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg); Drug: Placebo to match CK-4021586

Study type: Interventional

Funder types: Industry

Identifiers

NCT06793371

2024-516349-38-00 (EU Trial (CTIS) Number)

CY 9021

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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), 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 6 patient groups, including a placebo group

CK-4021586 - Cohort 1

Experimental group

Description:

Participants may receive 150 mg or 300 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total.

Treatment:

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

Placebo - Cohort 1

Placebo Comparator group

Description:

Participants will receive placebo daily for up to 12 weeks.

Treatment:

Drug: Placebo to match CK-4021586

CK-4021586 - Cohort 2

Experimental group

Description:

Participants may receive 300 mg or 450 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total.

Treatment:

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

Placebo - Cohort 2

Placebo Comparator group

Description:

Participants will receive placebo daily for up to 12 weeks.

Treatment:

Drug: Placebo to match CK-4021586

CK-4021586 - Cohort 3

Experimental group

Description:

Participants may receive 450 mg or 600 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total.

Treatment:

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

Placebo - Cohort 3

Placebo Comparator group

Description:

Participants will receive placebo daily for up to 12 weeks.

Treatment:

Drug: Placebo to match CK-4021586