NCT06793371

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Cytokinetics · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Symptomatic Heart Failure With Preserved Ejection Fraction (HFpEF)

Interventions

Type	Name	Description
DRUG	CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)	CK-4021586 administered orally
DRUG	Placebo to match CK-4021586	Placebo administered orally

Timeline

• Start date: 2025-02-06
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2025-01-27
• Last updated: 2026-01-12

Locations

24 sites across 1 country: United States

Regulatory

• FDA-regulated drug study