This is a Phase 2 placebo-controlled study to evaluate the safety and tolerability of different doses of EDG-15400 in adults with heart failure with preserved ejection fraction (HFpEF).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
EDG-15400 administered orally, once daily
Placebo administered orally, once daily
EDG-15400 administered orally, once daily
Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Incidence of TEAEs and SAEs observed during dosing of EDG-15400 in patients with HFpEF
Time frame: From baseline through study completion (up to 20 weeks)
Change in Biomarkers
Change from baseline values in NT-proBNP and hs-cTnI
Time frame: From baseline through study completion (up to 20 weeks)
EDG-15400 Plasma Concentrations
Observed pre and post-dose plasma concentrations measured throughout the study.
Time frame: From baseline through study completion (up to 20 weeks)
Study Director: Medical Director, Edgewise Therapeutics, Inc.
CONTACT
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