300 Participants Needed

CRF2 Agonist for Heart Failure

(CRAFT-WHF Trial)

Recruiting at 15 trial locations
CC
CO
Overseen ByClinical Operations Director
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Corteria Pharmaceuticals
Must be taking: Loop diuretics
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, COR-1167, a CRF2 agonist, to determine its effectiveness for patients hospitalized with worsening heart failure. The trial includes three groups receiving low, medium, and high doses of the drug, along with a placebo group. Individuals hospitalized for heart failure in the past year who require IV diuretics (medication to remove excess fluid) may qualify. The trial aims to assess whether COR-1167 can improve symptoms and outcomes for heart failure patients. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you must be on an oral loop diuretic for at least a month before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that COR-1167 is generally safe and well-tolerated in earlier studies. Tests with both healthy volunteers and patients revealed promising safety results, with no major side effects reported. This suggests the treatment might be safe for most people.

Although this trial is in an early stage, COR-1167 has already passed initial safety tests. However, further studies are needed to confirm these findings in people with heart failure. As the trial progresses, researchers will closely monitor safety.12345

Why do researchers think this study treatment might be promising for heart failure?

Researchers are excited about COR-1167 for heart failure because it offers a novel approach compared to existing treatments like ACE inhibitors, beta-blockers, and diuretics. Unlike these standard therapies, COR-1167 acts as a CRF2 agonist, targeting a unique pathway that could improve heart function more effectively. This new mechanism of action holds the potential for enhanced outcomes in heart failure management, sparking optimism among researchers.

What evidence suggests that this trial's treatments could be effective for heart failure?

Research has shown that COR-1167, a new treatment under study in this trial, offers promising results for people with worsening heart failure. This treatment activates a specific pathway in the body that protects the heart and improves its function. In earlier studies, patients who received COR-1167 demonstrated noticeable improvements in heart function. In this trial, participants will receive different doses of COR-1167 or a placebo. The treatment is administered once a day through an injection just under the skin. These findings suggest that COR-1167 could be an effective option for those with worsening heart failure.12346

Who Is on the Research Team?

JT

Jeffrey Testani, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults hospitalized with worsening heart failure who've had a similar hospital stay in the past year. They must have certain blood markers indicating heart stress, be on specific diuretics for at least a month, and show signs of resistance to these drugs. Participants need to join within 48 hours of their current hospital admission.

Inclusion Criteria

My NT-proBNP is 1000 pg/mL or higher, or my BNP is 250 pg/mL or higher.
I was hospitalized for heart failure in the last year.
I have at least one risk factor for not responding well to water pills.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the investigational drug COR-1167 or placebo for worsening heart failure

28 days
Daily visits for monitoring and administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • COR-1167
Trial Overview The study is testing COR-1167, an experimental drug, against a placebo to see if it can help people with severe heart failure. Patients will randomly receive either the real drug or a dummy pill without any active ingredients.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: COR-1167 low doseExperimental Treatment1 Intervention
Group II: COR-1167 intermediate doseExperimental Treatment1 Intervention
Group III: COR-1167 high doseExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Corteria Pharmaceuticals

Lead Sponsor

Trials
2
Recruited
340+

Worldwide Clinical Trials

Collaborator

Trials
70
Recruited
15,800+

Citations

CRF2 Agonist for the Treatment of Worsening Heart Failure ...This is a phase 2b, randomized, double-blind, placebo-controlled study designed to assess the dose-dependent effects of 3 doses of the ...
FIM COR-1167 ENCOR-1167 is a once-daily subcutaneous CRF2 agonist that has demonstrated substantial protective effects and functional improvement in the heart, ...
Corteria Pharmaceuticals initiates two trials with its CRF2 ...COR-1167 is a once‑daily, subcutaneous CRF2 peptide agonist being developed for the treatment of worsening heart failure (WHF). In a randomised, ...
Corteria Pharmaceuticals initiates Phase 2 trial in heart ...COR-1167 is a once‑daily, subcutaneous CRF2 peptide agonist being developed for the treatment of worsening heart failure (WHF). In a randomized, ...
Corteria advances CRF2 agonist programs in heart failure ...COR-1167 is a once-daily, subcutaneous peptide agonist designed to activate the CRF2 pathway in patients with worsening heart failure. Following ...
CRF2 Agonist for the Treatment of Worsening Heart FailureThis study assesses the effects of the investigational drug COR-1167 in subjects hospitalised due to worsening of heart failure (HF)
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