Corticotrophin Releasing Factor 2 Agonist For the Treatment of Worsening Heart Failure (Whf)

Investigation of CRF2 Agonist for Worsening Heart Failure

P
Peter Pang, MD

Primary Investigator

Enrolling By Invitation
18 years - 85 years
All
Phase 2
1 participants needed
1 Location

Brief description of study

This study assesses the effects of the investigational drug COR-1167 in subjects hospitalised due to worsening of heart failure (HF).

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

This is a phase 2b, randomized, double-blind, placebo-controlled study designed to assess the dose-dependent effects of 3 doses of the corticotropin-releasing factor type 2 (CRF2) peptide agonist, COR-1167, in subjects with WHF, defined as subjects requiring urgent administration of intravenous (i.v.) diuretics due to worsening of signs and symptoms of heart failure (HF) associated with volume overload

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) on: 1) natriuresis; 2) body weight; 3) levels of N-terminal pro B-type natriuretic peptide (NT-proBNP); 4) Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS); and 5) Left Atrial Volume Index (LAVi).

To evaluate the safety and tolerability of 3 s.c. doses of COR-1167 administered o.d. for 4 weeks to subjects with WHF.

To evaluate the potential immunogenicity of 3 s.c. doses of COR-1167 administered o.d. for 4 weeks to subjects with WHF.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Heart Failure
  • Age: 18 years - 85 years
  • Gender: All

Inclusion Criteria:

  • Signed written informed consent
  • Heart failure hospitalization (HFH) during previous 12 months
  • Prescribed an oral loop diuretic for at least 1 month preceding the index event
  • NT-proBNP ≥1,000 pg/mL or BNP ≥250 pg/mL
  • Requires treatment with i.v. diuretics for volume overload
  • At least 1 risk factor for diuretic resistance
  • Admitted to the hospital not more than 48 hours prior to randomization

Exclusion Criteria:

  • Index event primarily triggered by an acute event (e.g. AMI, PE, arrhythmia)
  • Requirement for i.v. inotropic therapy or i.v. vasodilators, mechanical ventilation, high-flow oxygen therapy, or NIV
  • Requirement for, or planned use of LVADs, IABP, or any type of MCS
  • History of solid organ transplant or active on a transplant list
  • SBP <100 mmHg
  • eGFR < 20 mL/min/1.73 m2
  • CABG, PCI, implantation of CRT, heart valve procedure or any cardiac surgery within 1 month prior to screening or planned during the study
  • Severe stenotic cardiac valvular disease
  • Severe chronic pulmonary disease requiring chronic steroid therapy or chronic oxygen therapy (> 2 L/min)
  • Uncorrected severe hyperthyroidism or hypothyroidism
  • Severe restrictive, obstructive, or infiltrative cardiomyopathy
  • Body weight < 70 kg
  • Use of any investigational drug(s) within 5 half-lives of screening
  • 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
  • Presence of any other conditions (e.g. geographic, social) actual or anticipated, that the Investigator feels would restrict or limit the subject's participation or compliance with all study procedures Subject is the Investigator or any Subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study

This study investigates the effects of an investigational medication on patients with worsening heart failure, a condition where the heart is not able to pump blood effectively. The purpose is to assess how different doses of a corticotropin-releasing factor type 2 (CRF2) peptide agonist affect patients who need urgent treatment with intravenous diuretics due to heart failure symptoms related to fluid overload.

Participants will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. They will receive one of three doses of the investigational medication or placebo once daily via subcutaneous injection for four weeks. Researchers will monitor changes in factors such as natriuresis, body weight, and specific heart failure markers, as well as evaluate the safety and potential immune response to the medication.

  • Who can participate: Adults hospitalized for heart failure in the past 12 months, who are currently receiving oral loop diuretics and require intravenous diuretics for volume overload, may be eligible. Participants must also meet specific biomarker criteria and have at least one risk factor for diuretic resistance.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo daily for four weeks. The study will involve monitoring the effects on heart failure symptoms and assessing safety and tolerability.
  • Study timelines: The study will last 4 weeks.
Updated on 14 Oct 2025. Study ID: ECRO-CORTERIA-CRAFT-WHF, 27621
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only