Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Study on COR-1167 for Patients with Worsening Heart Failure

Fast replyInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Featured sites

Sites that work closely with us on this trial

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is testing a medication called COR-1167 for people with worsening heart failure. Heart failure is a condition where the heart cannot pump blood effectively throughout the body, leading to fluid buildup, shortness of breath, and fatigue. When heart failure worsens, patients may experience increased fluid retention and more severe symptoms that require hospitalization and treatment with intravenous medications.

The purpose of this study is to evaluate how different doses of COR-1167 compare to a placebo in treating worsening heart failure. COR-1167 is a Corticotrophin Releasing Factor 2 Agonist, which is a type of medication being investigated for its potential to help the body eliminate excess fluid and improve heart function. The medication will be given as a daily subcutaneous injection (under the skin) for 4 weeks.

During the study, researchers will monitor several factors including: how much urine participants produce (natriuresis), changes in body weight, levels of certain heart failure markers in the blood (NT-proBNP), heart failure symptoms using a questionnaire, and measurements of heart structure (specifically the Left Atrial Volume Index, which indicates how much the upper left chamber of the heart is enlarged). The study will also evaluate the safety of the medication by monitoring for side effects and checking laboratory values.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Hospital Admission and Start of Trial

    You will begin the trial after being admitted to the hospital for worsening heart failure (a condition where your heart cannot pump blood effectively, leading to fluid buildup in your body).

    To qualify for the study, you must have been admitted to the hospital no more than 48 hours before joining the trial and still have significant fluid overload (at least 5 kg or 11 pounds of excess fluid) requiring intravenous diuretics.

    You must have had a heart failure hospitalization in the previous 12 months and been taking an oral water pill (loop diuretic) for at least 1 month before this hospital admission.

  2. Step 2

    Randomization and Treatment Assignment

    You will be randomly assigned to receive either COR-1167 (an investigational medication) or a placebo (a solution that looks the same but contains no active ingredient).

    If assigned to COR-1167, you will receive one of three different doses of the medication.

    The medication or placebo will be given as a daily injection under the skin (subcutaneous injection) using a pre-filled syringe.

  3. Step 3

    4-Week Treatment Period

    You will receive daily injections of either COR-1167 or placebo for a total of 4 weeks.

    Throughout this period, medical staff will monitor your condition and collect data on several important measures:

  4. Step 4

    Measurements and Assessments

    During the 4-week treatment period, the following will be regularly measured:

    Natriuresis: The amount of sodium excreted in your urine, which indicates how well your body is eliminating excess fluid.

    Body weight: Regular weight measurements will track fluid loss.

    NT-proBNP levels: Blood tests measuring a protein that increases when heart failure worsens.

    KCCQ Total Symptom Score: You'll complete questionnaires about your heart failure symptoms.

    Left Atrial Volume Index (LAVi): Imaging tests to measure a specific heart chamber size, which can indicate heart failure severity.

  5. Step 5

    Safety Monitoring

    Throughout the study, your safety will be closely monitored through:

    Blood and urine tests: To check various body functions including kidney function.

    Vital signs: Regular measurement of blood pressure, heart rate, breathing rate, and body temperature.

    Physical examinations: To assess your overall health status.

    Electrocardiogram (ECG): A test that records the electrical activity of your heart.

    Monitoring for side effects: Any unusual symptoms or adverse events will be documented.

  6. Step 6

    End of Treatment Assessment

    After completing the 4-week treatment period, a final set of assessments will be conducted.

    Blood samples will be taken to check for anti-drug antibodies (proteins your body might produce in response to the study medication).

    All the measurements taken during the study will be evaluated to determine how the different doses of COR-1167 affected your heart failure symptoms compared to placebo.

Who can join the trial?

10 criteria

  • You must have had a heart failure hospitalization during the previous 12 months
  • You must have been prescribed an oral loop diuretic (water pill to help remove excess fluid) for at least 1 month before the current event
  • Your NT-proBNP level must be ≥1,000 pg/mL or BNP level ≥250 pg/mL (these are blood tests that measure proteins released when your heart is under stress)
  • You need treatment with intravenous (IV) diuretics for fluid overload, which means you have:
    • Visible swelling (pitting edema), fluid in the abdomen (ascites), or fluid around the lungs (pleural effusion) AND
    • At least one of these signs: shortness of breath (dyspnea), crackling sounds in lungs (rales), fluid in lungs seen on imaging, or visible neck vein swelling (jugular venous distention)
    • You must have risk factors that make it harder for diuretics to work effectively (diuretic resistance)
    • You must be unable to have children or agree to use highly effective birth control from screening through 30 days after the last dose
    • You must provide signed written informed consent to participate in the study
    • You must have been admitted to the hospital no more than 48 hours before being randomly assigned to a treatment group
    • In your doctor's opinion, you must still have significant fluid overload (at least 5 kg or 11 pounds) requiring additional IV diuretic treatment

Who cannot join the trial?

12 criteria

  • You cannot participate if you have severe kidney problems (a condition where your kidneys don't work properly)
  • You cannot participate if you have a heart attack or unstable chest pain within the last 3 months
  • You cannot participate if you have heart valve disease (problems with the valves that control blood flow through your heart)
  • You cannot participate if you have had a heart transplant or are waiting for one
  • You cannot participate if you have a device to help your heart pump blood
  • You cannot participate if you are pregnant or breastfeeding
  • You cannot participate if you have a severe infection
  • You cannot participate if you have liver disease (a condition affecting your liver's ability to function)
  • You cannot participate if you have low blood pressure that causes symptoms
  • You cannot participate if you have been in another clinical trial within the last 30 days
  • You cannot participate if you are allergic to the study medication or any of its ingredients
  • You cannot participate if you have a history of alcohol or drug abuse
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

COR-1167 is an experimental medication that acts as a Corticotrophin Releasing Factor 2 Agonist. It's being studied for treating worsening heart failure. In this trial, it's administered once daily as an injection under the skin (subcutaneously) for a period of 4 weeks. The study is examining how this medication affects fluid balance in the body, heart failure symptoms, and heart function.

What is already known about the treatment

COR-1167 – A Corticotrophin Releasing Factor 2 agonist administered subcutaneously (under the skin) once daily. This investigational medication is being studied in clinical trials for the treatment of worsening heart failure, where it may help promote natriuresis (sodium excretion in urine) and potentially improve heart function. COR-1167 works at the molecular level by activating Corticotrophin Releasing Factor 2 receptors, which may influence fluid balance and cardiac function. Pharmacologically, it belongs to the class of neuropeptide receptor agonists and is being evaluated for effects on body weight, NT-proBNP levels (a heart failure marker), heart failure symptoms, and cardiac structure.

Investigated diseases

Worsening Heart Failure - A clinical condition characterized by a deterioration in the heart's ability to pump blood effectively, leading to a progression of heart failure symptoms. It represents an exacerbation of chronic heart failure where the heart muscle becomes increasingly unable to meet the body's demands for blood and oxygen. Patients typically experience increased fluid retention, shortness of breath, fatigue, and reduced exercise capacity. The condition involves progressive ventricular remodeling and neurohormonal activation that further impair cardiac function. Worsening heart failure may occur gradually or suddenly as an acute decompensation of previously stable heart failure.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518951-52-00Protocol codeCOR1167-201Estimated enrolment300 patientsSponsorCorteria Pharmaceuticals

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.