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COR-1167 (CRF2 agonist) to treat worsening heart failure

Corticotrophin Releasing Factor 2 for the Treatment of Worsening Heart Failure (WHF) - The CRAFT-WHF Study

Phase 2 Interventional Corteria Pharmaceuticals · NCT06815471

This trial tests whether the drug COR-1167 can help people hospitalized with worsening heart failure who need intravenous diuretics.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorCorteria Pharmaceuticals Industry-sponsored
Locations55 sites (Indianapolis, Indiana and 54 other locations)
Trial IDNCT06815471 on ClinicalTrials.gov

What this trial studies

This phase 2, randomized, double-blind, placebo-controlled study tests three dose levels of COR-1167, a corticotropin-releasing factor type 2 (CRF2) peptide agonist, in patients hospitalized for worsening heart failure. Participants are randomized to one of three dose arms or placebo and receive study drug while admitted for volume overload requiring urgent IV diuretics. Key inclusion features include recent heart failure hospitalization, elevated natriuretic peptides, prior oral loop diuretic use, and at least one risk factor for diuretic resistance, while major exclusions include acute triggers like myocardial infarction, need for inotropes or mechanical circulatory support, very low blood pressure, or severe renal impairment. The study compares dose-dependent clinical and biomarker effects versus placebo to inform the design of larger trials.

Who should consider this trial

Good fit: Ideal candidates are adults hospitalized within 48 hours for worsening heart failure with volume overload who require IV diuretics, have elevated BNP/NT-proBNP, prior HF hospitalization, and at least one risk factor for diuretic resistance.

Not a fit: Patients whose worsening is primarily caused by an acute event (such as MI, pulmonary embolism, or serious arrhythmia), those needing inotropic support, high-flow oxygen, mechanical ventilation or circulatory support, or those with very low systolic blood pressure or severe renal failure are unlikely to benefit.

Why it matters

Potential benefit: If successful, COR-1167 could improve removal of excess fluid, relieve symptoms during acute heart failure hospitalizations, and shorten hospital stays or reduce readmissions.

How similar studies have performed: Targeting CRF2 with a peptide agonist in acute worsening heart failure is a relatively novel approach with limited prior clinical data, so meaningful benefit remains unproven.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Indianapolis, Indiana and 54 other locations

+5 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Worsening Heart FailureCOR-1167Hospitalised heart failureWHF
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.