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

Conditions

• Symptomatic Heart Failure With Preserved Ejection Fraction (HFpEF)

Eligibility Criteria

Sex

ALL

Age

40 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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

Key Dates

First listed

Jan 27, 2025

Start date

Feb 6, 2025

Status verified

Jan 2026

Primary completion

Sep 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• Placebo Comparator: Placebo - Cohort 1
  Participants will receive placebo daily for up to 12 weeks.
• 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.
• Placebo Comparator: Placebo - Cohort 2
  Participants will receive placebo daily for up to 12 weeks.
• 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.
• Placebo Comparator: Placebo - Cohort 3
  Participants will receive placebo daily for up to 12 weeks.

Primary Outcome Measure

Incidence of early drug discontinuation [ Time Frame: 12 weeks ]

Central Contacts

• Cytokinetics MD
  650-624-2929
  [email protected]

Locations (26)

Find similar trials in Fairhope, AL