CRF2 Agonist for the Treatment of Worsening Heart Failure

Phase 2

Recruiting

• Conditions: Worsening Heart Failure
• Interventions: Drug: COR-1167; Drug: Placebo

• Registration Number: NCT06815471
• Lead Sponsor: Corteria Pharmaceuticals

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-03
• Study First Posted: 2025-02-07
• Status Verified: 2025-08
• Study Start: 2025-08-07
• Last Update Submitted: 2025-08-12
• Last Update Posted: 2025-08-15
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COR-1167 intermediate dose	COR-1167	-
COR-1167 high dose	COR-1167	-
Placebo	Placebo	-
COR-1167 low dose	COR-1167	-

Primary Outcome Measures

Name	Time	Method
Body weight	7 days	Changes in body weight
NT-proBNP	7 days	Changes in NT-proBNP
Left Atrial Volume index (LAVi)	2 days	Changes in LAVi - LAV-i is an index of cardiac function measured by echocardiogram
Natriuresis	24 hours	Urinary sodium excretion
Kansas City Cardiomyopathy Questionnaire (KCCQ)-Total Symptom Score (TSS)	28 days	Changes in KCCQ-TSS - The score ranges from 0 to 100 with higher score indicating a better health status

Trial Locations

Locations (10)

South Oklahoma Heart Research, LLC; 🇺🇸 Oklahoma City, Oklahoma, United States

Aleksandre Aladashvili Clinic LLC; 🇬🇪 Tbilisi, Georgia

LTD "Israeli-Georgian Medical Research Clinic Healthycore"; 🇬🇪 Tbilisi, Georgia

Acad. G. Chapidze Emergency Cardiology Center LTD, Department of Internal Medicine and Medical Research; 🇬🇪 Tbilisi, Georgia

Acad. G.Chapidze Emergency Cardiology Center, LTD, Department of Multi-center Clinical Trials; 🇬🇪 Tbilisi, Georgia

Bokhua Memorial Cardiovascular Center LTD; 🇬🇪 Tbilisi, Georgia

St. Michael's Hospital LLC; 🇬🇪 Tbilisi, Georgia

Tbilisi Heart and Vascular Clinic, LTD; 🇬🇪 Tbilisi, Georgia

Georgian Dutch Hospital; 🇬🇪 Tbilisi, Georgia

LTD Tbilisi Heart Center; 🇬🇪 Tbilisi, Georgia