Recruiting
Phase 2

CRD-4730

Sponsor:

Cardurion Pharmaceuticals, Inc.

Code:

NCT07750873

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CRD-4730

Placebo

Study Details

Brief summary:

CRD-4730 is a calcium/calmodulin-dependent protein kinase II (CaMKII) inhibitor. The CALIBRATE-HF trial is a Phase 2, global, multi-center, randomized, double-blind, parallel-group, placebo-controlled trial. The trial will evaluate the efficacy, safety, and tolerability of CRD-4730 in addition to guideline directed medical therapy in participants with heart failure with reduced ejection fraction (HFrEF). Participants will be randomized to 1 of 4 study groups and receive investigational study drug or placebo twice daily (BID) for 24 weeks of treatment.

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF)

Study ID

NCT07750873

Start date

Jul 15, 2026

Status verified date

Aug, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult male or female patient ≥ 18 years of age and ≤ 85 years of age at the time of screening.
  • Has a medical history supporting a diagnosis of clinical chronic heart failure (HF) syndrome with a duration of at least 8 weeks prior to the time of screening and current NYHA functional class II to III (based on investigator's assessment).
  • Has left ventricular ejection fraction ≤ 40% by a centrally read transthoracic echocardiogram performed during screening.
  • Has NT-proBNP level ≥ 600 pg/mL (70.8 pmol/L) at the time of screening. Patients in atrial fibrillation or flutter at the time of screening are required to have an NT-proBNP level of ≥ 900 pg/mL (106.4 pmol/L).
  • Is receiving optimized and stable guideline directed HF therapy (per applicable regional or national guidelines).

Exclusion Criteria:

  • Has evidence of recent HF exacerbation defined by hospitalization or requirement for IV or SQ diuretics within 4 weeks of the time of screening or during the Screening Period.
  • Has a requirement for routine, scheduled outpatient IV infusions for HF (ie, inotropes, vasodilators, or diuretics) or routinely scheduled ultrafiltration.
  • Has acute coronary syndrome, unstable angina, persistent angina at rest, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, cardiac valve repair (surgical or nonsurgical) or surgical replacement, or carotid angioplasty within 8 weeks prior to screening or during the Screening Period.
  • Has clinical suspicion of infiltrative cardiomyopathy (eg, amyloid, sarcoid), hypertrophic cardiomyopathy (obstructive or non-obstructive), or HF secondary to severe valvular disease, active myocarditis, active pericarditis, or clinically significant congenital heart disease.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

525 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study Arm 1: CRD-4730 Dose A tablet

Participants will receive Dose A of CRD-4730 administered orally twice daily for 24 weeks

experimental: Study Arm 2: CRD-4730 Dose B tablet

Participants will receive Dose B of CRD-4730 administered orally twice daily for 24 weeks

experimental: Study Arm 3: CRD-4730 Dose C tablet

Participants will receive Dose C of CRD-4730 administered orally twice daily for 24 weeks

placebo comparator: Study Arm 4: Matched Placebo tablet

Participants will receive placebo administered orally twice daily for 24 weeks

Interventions

CRD-4730

Experimental, Dose A, B and C

Placebo

Placebo

Primary outcome measure

  • Change from Baseline in Composite Z-Score at 24 weeks [ Time Frame: Baseline and Week 24 ]

Central Contacts and Locations

Central contacts

Cardurion Pharmaceuticals

617-863-8088ClinicalTrialsGov@cardurion.com

Locations

Cardurion Investigative Site

Recruiting

Pasadena, California, United States, 91105

Contacts

Gregory Giesler

626-793-1227gregory.giesler@profoundresearch.io

Cardurion Investigative Site

Recruiting

Bloomfield Hills, Michigan, United States, 48304

Contacts

Abdul-Rahman Halabi

248-282-3639abdul.halabi@profoundresearch.io

More Information

Sponsor

Cardurion Pharmaceuticals, Inc.

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Heart failure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Cardurion Pharmaceuticals, Inc. on 2026-08-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.