A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-15400 in Adults With Symptomatic Heart Failure With Preserved Ejection Fraction

Edgewise Therapeutics, Inc.

Summary

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).

Eligibility

Age range: 30–84 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Males and nonpregnant females, ages ≥30 to \<85 years of age at screening * Body weight ≥ 45 kg, BMI \< 40 * LVEF ≥ 50% * Diagnosed with Heart Failure per American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Failure Society of America (HFSA) Guidelines for the Management of Heart Failure * New York Heart Association (NYHA) functional class II or III * If receiving Guideline-directed Medical Therapy, must be on stable doses * Participants receiving a GLP-1 agonist prior to Screening must have no anticipated plans to change dose during the study Exc…

Interventions

Drug
EDG-15400 25 mg
EDG-15400 administered orally, once daily
Drug
Placebo to match EDG-15400 25 mg or 50 mg
Placebo administered orally, once daily
Drug
EDG-15400 50 mg
EDG-15400 administered orally, once daily

Locations (28)

Local Institution - 1
Birmingham, Alabama
Local Institution - 25
Little Rock, Arkansas
Local Institution - 2
Beverly Hills, California
Local Institution - 3
San Diego, California
Local Institution - 4
Vista, California
Local Institution - 24
Gainesville, Florida

Eligibility

Age range

30–84 years

Sex

All

Healthy volunteers

Detailed criteria