COR-1167 SODIUM for Worsening heart failure

Inclusion criteria

• {"criterion_text":"- 1) Heart failure hospitalization (HFH) during previous 12 months"}
• {"criterion_text":"- 2) Prescribed an oral loop diuretic for at least 1 month preceding the index event"}
• {"criterion_text":"- 3) NT-proBNP ≥1,000 pg/mL or B-type natriuretic peptide (BNP) ≥250 pg/mL"}
• {"criterion_text":"- 4) Requires treatment with i.v. diuretics for volume overload (the index event) defined by the presence of a. clinically significant extravascular volume overload evidenced by pitting edema, ascites, or pleural effusion AND b. ≥1 of the following clinical signs and symptoms of congestion: i. Dyspnea at rest ii. Rales heard on auscultation iii. Pulmonary congestion identified by diagnostic imaging (e.g. interstitial or alveolar edema on chest X-ray or B lines on lung ultrasound) (pleural effusion does not affect the lung parenchyma and cannot be used as a sign of pulmonary congestion) iv. Jugular venous distention"}
• {"criterion_text":"- 5) Risk factors for diuretic resistance"}
• {"criterion_text":"- 6) Unable to procreate or must agree to use a highly effective form of birth control from screening through 30 days after the last dose of study treatment"}
• {"criterion_text":"- 7) Signed written informed consent to participate in the study in accordance with local regulations"}
• {"criterion_text":"- 8) Admitted to the hospital not more than 48 hours prior to randomization"}
• {"criterion_text":"- 9) In the opinion of the investigator, participant continues to have significant volume overload (≥5 kg) requiring treatment with additional i.v. loop diuretics"}

Exclusion criteria

• {"criterion_text":"- 1) Age <18 years (or legal age for the country of participation) or >85 years atscreening"}
• {"criterion_text":"- 10) Severe chronic pulmonary disease requiring chronic steroid therapy or chronic oxygen therapy (> 2 L/min)"}
• {"criterion_text":"- 11) Uncorrected severe hyperthyroidism or hypothyroidism. Note: Severe hyperthyroidism refers to persistent symptomatology (e.g. tachycardia, weight loss, tremors, anxiety, sweating, goiter) despite treatment. Severe hypothyroidism refers to persistent symptomatology (e.g. extreme fatigue, weight gain, cold intolerance, constipation, hair loss, voice changes, depression, swelling around the eyes) despite treatment."}
• {"criterion_text":"- 12) Severe restrictive, obstructive, or infiltrative cardiomyopathy"}
• {"criterion_text":"- 13) Body weight < 70 kg"}
• {"criterion_text":"- 14) Use of any investigational drug(s) within 5 half-lives of screening"}
• {"criterion_text":"- 15) At high risk of death (defined as life expectancy ≤1 year) from causes other than heart failure or any disease that, in the opinion of the Investigator, will preclude their safe participation in this study, and will make implementation of the protocol or interpretation of the study results difficult"}
• {"criterion_text":"- 16) Presence of any other conditions actual or anticipated, that the Investigator feels would restrict or limit the subject’s participation or compliance with all study procedures"}
• {"criterion_text":"- 17) Subject is the Investigator or any Sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study"}
• {"criterion_text":"- 2) Index event primarily triggered by one of the following events: a. pulmonary embolism b. cerebrovascular accident c. acute myocardial infarction d. significant arrhythmia (e.g.,sustained ventricular tachycardia, or atrial fibrillation/flutter with sustained ventricular response >130 beats per minute, or bradycardia with sustained ventricular rate <45 beats per minute) e. infection (requiring intravenous antibiotics and/or with fever > 101.5 F / 38.5 C) f. severe anemia (hemoglobin <7g/dl) g. exacerbation of chronic obstructive pulmonary disease (COPD)"}
• {"criterion_text":"- 3) Requirement for i.v. inotropic therapy or i.v. vasodilators (except for nitrates), mechanical ventilation, high-flow oxygen therapy, or noninvasive ventilation (NIV) (use of continuous positive airway pressure [CPAP] for obstructive sleep apnea is allowed)"}
• {"criterion_text":"- 4) Requirement for, or planned use of left ventricular assist devices (LVADs), intra-aortic balloon pump (IABP), or any type of mechanical circulatory support (MCS)"}
• {"criterion_text":"- 5) History of solid organ transplant or active on a transplant list"}
• {"criterion_text":"- 6) Systolic blood pressure (SBP) <100 mmHg at randomization"}
• {"criterion_text":"- 7) Estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73 m2 at screening"}
• {"criterion_text":"- 8) Coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of cardiac resynchronization therapy [CRT]), heart valve procedure or any cardiac surgery within 1 month prior to screening or planned during the study. Note: Remote monitoring devices such as cardioMEMS and implantable cardioverter-defibrillators (ICDs) are not an exclusion."}
• {"criterion_text":"- 9) Severe stenotic cardiac valvular disease"}

Primary endpoints

• {"endpoint_text":"- Natriuresis\n- Body weight\n- NT-proBNP\n- KCCQ-TSS\n- LAVi","definition_or_measurement_approach":"To evaluate the dose-effect relationship of 3 doses of COR-1167 versus placebo administered once daily (o.d.) subcutaneously (s.c.) for 4 weeks to subjects with worsening heart failure (WHF)."}

Secondary endpoints

• {"endpoint_text":"- Safety and tolerability of 3 s.c. o.d. doses of COR-1167, as assessed by the following parameters: o Clinical safety laboratory parameters (hematology, chemistry, coagulation, urinalysis, eGFR) o Vital signs (blood pressure, heart rate, respiratory rate, and body temperature) o Physical examinations o 12-lead electrocardiogram (ECG) o Adverse events (AEs)","definition_or_measurement_approach":"Assessment of clinical safety laboratory parameters (hematology, chemistry, coagulation, urinalysis, eGFR), vital signs (blood pressure, heart rate, respiratory rate, and body temperature), physical examinations, 12-lead ECG, and recording of adverse events."}
• {"endpoint_text":"- Anti-drug antibody (ADA) semi-quantitative determination after 28-day treatment with COR-1167","definition_or_measurement_approach":"Semi-quantitative laboratory determination of anti-drug antibodies (ADA) after 28 days of COR-1167 treatment."}

Czechia

Earliest CTIS Part Ii Submission Date

07-07-2025

Latest Decision Or Authorization Date

06-03-2026

Processing Time Days

242

Number Of Sites

5

Number Of Participants

33

Hungary

Earliest CTIS Part Ii Submission Date

09-07-2025

Latest Decision Or Authorization Date

09-03-2026

Processing Time Days

243

Number Of Sites

8

Number Of Participants

29

Romania

Earliest CTIS Part Ii Submission Date

11-07-2025

Latest Decision Or Authorization Date

11-03-2026

Processing Time Days

243

Number Of Sites

6

Number Of Participants

29

Spain

Earliest CTIS Part Ii Submission Date

10-07-2025

Latest Decision Or Authorization Date

10-03-2026

Processing Time Days

243

Number Of Sites

10

Number Of Participants

38

Primary sponsor

Full Name

Corteria Pharmaceuticals

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Contract research organisations

Name

Worldwide Clinical Trials Holdings Inc.

Name

Duke Clinical Research Institute

Name

Medidata Solutions Inc.

Name

Acm Medical Laboratory Inc.

Name

Acm Global Central Laboratory Limited

Third parties

• {"country":"United States","full_name":"Duke Clinical Research Institute","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Acm Medical Laboratory Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Acm Global Central Laboratory Limited","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Worldwide Clinical Trials Holdings Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}