Heart Failure with Preserved Ejection Fraction (HFpEF) Clinical Trials

Find Heart Failure with Preserved Ejection Fraction (HFpEF) Clinical Trials Near You

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

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 84
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
Local Institution - 156
NOT_YET_RECRUITING
Birmingham
California
Local Institution - 162
NOT_YET_RECRUITING
Beverly Hills
Local Institution - 120
NOT_YET_RECRUITING
San Diego
Local Institution - 149
RECRUITING
Vista
Illinois
Local Institution - 153
NOT_YET_RECRUITING
Peoria
Indiana
Local Institution - 166
NOT_YET_RECRUITING
Indianapolis
Kentucky
Local Institution - 160
NOT_YET_RECRUITING
Cynthiana
Louisiana
Local Institution - 155
NOT_YET_RECRUITING
Houma
Maryland
Local Institution - 106
NOT_YET_RECRUITING
Baltimore
Michigan
Local Institution - 158
NOT_YET_RECRUITING
Ypsilanti
Missouri
Local Institution - 145
NOT_YET_RECRUITING
Kansas City
Local Institution - 109
NOT_YET_RECRUITING
St Louis
Mississippi
Local Institution - 164
NOT_YET_RECRUITING
Jackson
North Carolina
Local Institution - 159
NOT_YET_RECRUITING
Greensboro
New York
Local Institution - 154
NOT_YET_RECRUITING
New York
Ohio
Local Institution - 129
NOT_YET_RECRUITING
Cincinnati
Pennsylvania
Local Institution - 165
NOT_YET_RECRUITING
Mechanicsburg
Local Institution - 124
NOT_YET_RECRUITING
Pittsburgh
South Carolina
Local Institution - 142
NOT_YET_RECRUITING
Charleston
Texas
Local Institution - 167
NOT_YET_RECRUITING
Dallas
Local Institution - 151
NOT_YET_RECRUITING
Houston
Local Institution - 157
NOT_YET_RECRUITING
Houston
Local Institution - 163
NOT_YET_RECRUITING
Houston
Virginia
Local Institution - 143
NOT_YET_RECRUITING
Charlottesville
Washington
Local Institution - 132
NOT_YET_RECRUITING
Seattle
Contact Information
Primary
Study Director: Medical Director, Edgewise Therapeutics, Inc.
hfstudies@edgewisetx.com
720-262-7002
Time Frame
Start Date: 2026-08-25
Estimated Completion Date: 2027-12
Participants
Target number of participants: 90
Treatments
Experimental: EDG-15400 25 mg
Experimental: EDG-15400 50 mg
Placebo_comparator: Placebo
Sponsors
Leads: Edgewise Therapeutics, Inc.

This content was sourced from clinicaltrials.gov