A Study of EDG-15400 in Adults With Heart Failure With Preserved Ejection Fraction (EQUINOX-HFpEF)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Edgewise Therapeutics, Inc.
Study ID
NCT07795814
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 84 Years
Healthy Volunteers
Not accepted

Interventions

  • EDG-15400 25 mg — DRUG
    EDG-15400 administered orally, once daily
  • Placebo to match EDG-15400 25 mg or 50 mg — DRUG
    Placebo administered orally, once daily
  • EDG-15400 50 mg — DRUG
    EDG-15400 administered orally, once daily

Study Details

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).

Key Dates

First listed
Aug 31, 2026
Start date
Aug 25, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EDG-15400 25 mg
  • Experimental: EDG-15400 50 mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: From baseline through study completion (up to 20 weeks) ]

Central Contacts

  • Study Director: Medical Director, Edgewise Therapeutics, Inc.
    720-262-7002
    [email protected]

Locations (25)

FacilityCityStateZIPSite coordinators
Local Institution - 156BirminghamAlabama35211-
Local Institution - 162Beverly HillsCalifornia90211-
Local Institution - 120San DiegoCalifornia92037-
Local Institution - 149VistaCalifornia92081-
Local Institution - 153PeoriaIllinois61636-
Local Institution - 166IndianapolisIndiana46260-
Local Institution - 160CynthianaKentucky41031-
Local Institution - 155HoumaLouisiana70360-
Local Institution - 106BaltimoreMaryland21287-
Local Institution - 158YpsilantiMichigan48197-
Local Institution - 164JacksonMississippi39216-
Local Institution - 145Kansas CityMissouri64131-
Local Institution - 109St LouisMissouri63130-
Local Institution - 154New YorkNew York10019-
Local Institution - 159GreensboroNorth Carolina27401-
Local Institution - 129CincinnatiOhio45219-
Local Institution - 165MechanicsburgPennsylvania17050-
Local Institution - 124PittsburghPennsylvania15213-
Local Institution - 142CharlestonSouth Carolina29425-
Local Institution - 167DallasTexas75390-
Local Institution - 151HoustonTexas77030-
Local Institution - 157HoustonTexas77030-
Local Institution - 163HoustonTexas77030-
Local Institution - 143CharlottesvilleVirginia22908-
Local Institution - 132SeattleWashington98101-

Find similar trials in Birmingham, AL

Nationwide
Heart failure trialsCardiology trialsHeart disease trials
By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Local Institution - 156· Birmingham, ALLocal Institution - 162· Beverly Hills, CALocal Institution - 120· San Diego, CALocal Institution - 149· Vista, CALocal Institution - 153· Peoria, ILLocal Institution - 166· Indianapolis, IN

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