CRF2 Agonist for the Treatment of Worsening Heart Failure

NCT ID: NCT06815471

Last Updated: 2025-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-07

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Worsening Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Sponsor CRO

Study Groups

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COR-1167 low dose

Group Type EXPERIMENTAL

COR-1167

Intervention Type DRUG

28-day treatment

COR-1167 intermediate dose

Group Type EXPERIMENTAL

COR-1167

Intervention Type DRUG

28-day treatment

COR-1167 high dose

Group Type EXPERIMENTAL

COR-1167

Intervention Type DRUG

28-day treatment

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

28-day treatment

Interventions

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COR-1167

28-day treatment

Intervention Type DRUG

Placebo

28-day treatment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Worldwide Clinical Trials

OTHER

Sponsor Role collaborator

Corteria Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Testani, MD

Role: STUDY_CHAIR

Yale University

Locations

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Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

Site Status NOT_YET_RECRUITING

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, United States

Site Status NOT_YET_RECRUITING

South Oklahoma Heart Research, LLC

Oklahoma City, Oklahoma, United States

Site Status NOT_YET_RECRUITING

Aleksandre Aladashvili Clinic LLC

Tbilisi, , Georgia

Site Status RECRUITING

LTD "Israeli-Georgian Medical Research Clinic Healthycore"

Tbilisi, , Georgia

Site Status RECRUITING

Acad. G. Chapidze Emergency Cardiology Center LTD, Department of Internal Medicine and Medical Research

Tbilisi, , Georgia

Site Status RECRUITING

Acad. G.Chapidze Emergency Cardiology Center, LTD, Department of Multi-center Clinical Trials

Tbilisi, , Georgia

Site Status RECRUITING

Bokhua Memorial Cardiovascular Center LTD

Tbilisi, , Georgia

Site Status NOT_YET_RECRUITING

St. Michael's Hospital LLC

Tbilisi, , Georgia

Site Status NOT_YET_RECRUITING

Tbilisi Heart and Vascular Clinic, LTD

Tbilisi, , Georgia

Site Status RECRUITING

Georgian Dutch Hospital

Tbilisi, , Georgia

Site Status RECRUITING

LTD Tbilisi Heart Center

Tbilisi, , Georgia

Site Status RECRUITING

Clinical Hospital Center "Dr Dragisa Misovic Dedinje"

Belgrade, , Serbia

Site Status NOT_YET_RECRUITING

University Clinical Center of Serbia, Clinic for Cardiology, Emergency Cardiology Department

Belgrade, , Serbia

Site Status NOT_YET_RECRUITING

University Clinical Center of Serbia, Clinic for Cardiology

Belgrade, , Serbia

Site Status NOT_YET_RECRUITING

General Hospital Leskovac, Cardiology Department

Leskovac, , Serbia

Site Status NOT_YET_RECRUITING

Countries

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United States Georgia Serbia

Central Contacts

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Corteria Chief Medical Officer

Role: CONTACT

610-787-2998

Clinical Operations Director

Role: CONTACT

References

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Rademaker MT, Charles CJ, Ellmers LJ, Lewis LK, Nicholls MG, Richards AM. Prolonged urocortin 2 administration in experimental heart failure: sustained hemodynamic, endocrine, and renal effects. Hypertension. 2011 Jun;57(6):1136-44. doi: 10.1161/HYPERTENSIONAHA.111.173203. Epub 2011 May 2.

Reference Type RESULT
PMID: 21536988 (View on PubMed)

Rademaker MT, Charles CJ, Nicholls MG, Richards AM. Urocortin 2 inhibits furosemide-induced activation of renin and enhances renal function and diuretic responsiveness in experimental heart failure. Circ Heart Fail. 2009 Nov;2(6):532-40. doi: 10.1161/CIRCHEARTFAILURE.109.861336. Epub 2009 Sep 22.

Reference Type RESULT
PMID: 19919977 (View on PubMed)

Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.

Reference Type RESULT
PMID: 27207191 (View on PubMed)

Chan WY, Frampton CM, Crozier IG, Troughton RW, Richards AM. Urocortin-2 infusion in acute decompensated heart failure: findings from the UNICORN study (urocortin-2 in the treatment of acute heart failure as an adjunct over conventional therapy). JACC Heart Fail. 2013 Oct;1(5):433-41. doi: 10.1016/j.jchf.2013.07.003. Epub 2013 Sep 11.

Reference Type RESULT
PMID: 24621976 (View on PubMed)

Rubio-Gracia J, Demissei BG, Ter Maaten JM, Cleland JG, O'Connor CM, Metra M, Ponikowski P, Teerlink JR, Cotter G, Davison BA, Givertz MM, Bloomfield DM, Dittrich H, Damman K, Perez-Calvo JI, Voors AA. Prevalence, predictors and clinical outcome of residual congestion in acute decompensated heart failure. Int J Cardiol. 2018 May 1;258:185-191. doi: 10.1016/j.ijcard.2018.01.067.

Reference Type RESULT
PMID: 29544928 (View on PubMed)

Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):399-410. doi: 10.1161/01.cir.0000442015.53336.12. No abstract available.

Reference Type RESULT
PMID: 24446411 (View on PubMed)

Other Identifiers

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COR1167-201

Identifier Type: -

Identifier Source: org_study_id

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