Effects of Ziltivekimab Versus Placebo on Heart Failure Symptoms and Physical Function in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation

New heart failure drug Ziltivekimab tested in Phase 3 trial

NCT: NCT06200207 · Status: RECRUITING · Phase: Phase 3 · Sponsor: Novo Nordisk A/S · Started: 2024-04-01 · Est. Completion: 2027-01-08

Plain English Summary

A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation is a Phase 3 clinical trial sponsored by Novo Nordisk A/S studying Heart Failure, Systemic Inflammation. This study tests if Ziltivekimab, a new drug, can improve heart failure symptoms and physical function compared to a placebo. It is for adults with heart failure and inflammation who can walk at least 100 meters. Participants will receive either Ziltivekimab or a placebo injection once a month for about a year. Currently, there are no approved treatments specifically for heart failure with inflammation, making this trial important. The trial aims to enroll 680 participants.

Official Summary

The study is being done to see if ziltivekimab can be used to treat participants living with heart failure and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (inactive substance that looks like the study medicine but does not contain any medicine). The treatment participants get is decided by chance. Participant's chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study is expected to last for up to 1 year and 4 months.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with a diagnosis of heart failure (NYHA Class II-III) and elevated inflammation markers. Individuals must have a specific range of heart function measurements (left ventricular ejection fraction > 40%) and heart chamber sizes. Participants must be able to complete a 6-minute walk test and have a certain score on a quality of life questionnaire. People who have had a heart attack, stroke, or heart failure hospitalization in the last 30 days, or have very high or low heart rates, cannot join. This trial is studying Heart Failure, Systemic Inflammation, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to see if the drug improves a patient's overall quality of life and symptom experience, as measured by a standard questionnaire for heart failure patients. The specific primary outcome measures are: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS) (From randomisation (month 0) to end-of-treatment (month 12)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a gap in treatment for heart failure patients who also have systemic inflammation, a condition that can worsen heart function and symptoms. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Heart Failure, Systemic Inflammation, where improved treatment options are needed.

Investor Insight

This Phase 3 trial for Ziltivekimab, a novel anti-inflammatory drug for heart failure, signals significant investment in a large patient population with unmet needs, suggesting a potentially high prob Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 680 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if Ziltivekimab is appropriate for you and what the potential benefits and risks are. Participation involves monthly injections for about 16 months, with regular check-ups and tests to monitor your health and the drug's effects. You will need to be able to perform a 6-minute walk test and complete quality of life questionnaires. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 milligrams per liter (mg/L) at screening (visit 1)
* Disease specific - cardiovascular:
* N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than or equal to 225 picograms per milliliter (pg/mL) (375 pg/mL for participants with atrial fibrillation/flutter) at screening
* Diagnosis of heart failure (New York heart association (NYHA) Class II-III)
* Left ventricular ejection fraction (LVEF) greater than 40 percent documented by echocardiography within 12 months prior to or at screening (visit 1). The LVEF must be documented in medical records and the most recent measurement must be used to determine eligibility with no interim event signalling potential deterioration in ejection fraction (example myocardial infarction (MI) or heart failure (HF) hospitalisation)
* Structural heart disease and/or functional heart disease documented by echocardiography within 12 months prior to or at screening (visit 1) showing at least one of the following:

  1. Left atrial (LA) volume index greater than 34 milliliter per square meter (mL/m\^2)
  2. LA diameter greater than or equal to 3.8 centimeter (cm)
  3. LA length greater than or equal to 5.0 cm
  4. LA area greater than or equal to 20 square centimeter (cm\^2)
  5. LA volume greater than or equal to 55 milliliter (mL)
  6. Intraventricular septal thickness greater than or equal to 1.1 cm
  7. Posterior wall thickness greater than or equal to 1.1 cm
  8. LV mass index greater than or equal to 115 gram per square meter (g/m\^2) in men or greater than or equal to 95 g/m\^2 in women

  h) E/e' (mean septal and lateral) greater than or equal to 10 i) e' (mean septal and lateral) less than 9 centimeter per second (cm/s)
* No heart failure hospitalisations or urgent heart failure visits between screening and randomisation
* Able to perform the 6-minute walk test (6MWT) at screening with a minimum distance of 100 metres
* Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score lesser than 80 at screening

Exclusion Criteria:

* Medical conditions - cardiovascular:
* Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation within 30 days prior to screening (visit 1)
* Systolic blood pressure greater than or equal to 180 millimeters of mercury (mmHg) at screening (visit 1). If the systolic blood pressure is 160-179 mmHg, the patient should be receiving greater than or equal to 3 antihypertensive drugs
* Heart rate above 110 or below 40 beats per minute as evaluated on the Electrocardiogram (ECG) performed at screening (visit 1)
* Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1)
* Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1)
* Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2)
* Heart failure due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary valve disease
* Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including chronic obstructive pulmonary disease (COPD)
* Any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anaemia, hypothyroidism)
* Medical conditions - infections/immunosuppression:
* Clinical evidence of, or suspicion of, active infection at the discretion of the investigator

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06200207?

NCT06200207 is a Phase 3 INTERVENTIONAL study titled "A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation." It is currently recruiting and is sponsored by Novo Nordisk A/S. The trial targets enrollment of 680 participants.

What conditions does NCT06200207 study?

This trial investigates treatments for Heart Failure, Systemic Inflammation. The primary condition under study is Heart Failure.

What treatments are being tested in NCT06200207?

The interventions being studied include: Ziltivekimab (DRUG), Placebo (DRUG). Zilitivekimab will be administered subcutaneously once-monthly.

What does Phase 3 mean for NCT06200207?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT06200207?

This trial is currently "Recruiting." It started on 2024-04-01. The estimated completion date is 2027-01-08.

Who is sponsoring NCT06200207?

NCT06200207 is sponsored by Novo Nordisk A/S. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06200207?

The trial aims to enroll 680 participants. The trial is currently recruiting and accepting new participants.

How is NCT06200207 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT06200207?

The primary outcome measures are: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS) (From randomisation (month 0) to end-of-treatment (month 12)). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06200207 being conducted?

This trial is being conducted at 20 sites, including Alexander City, Alabama; Fairhope, Alabama; Little Rock, Arkansas; Northridge, California and 16 more sites (United States).

Where can I find official information about NCT06200207?

The official record for NCT06200207 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06200207. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06200207 testing in simple terms?

This study tests if Ziltivekimab, a new drug, can improve heart failure symptoms and physical function compared to a placebo. It is for adults with heart failure and inflammation who can walk at least 100 meters.

Why is this trial significant?

This trial addresses a gap in treatment for heart failure patients who also have systemic inflammation, a condition that can worsen heart function and symptoms. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT06200207?

The most common side effects may include injection site reactions (redness, swelling, or pain where the shot is given). Other potential risks include changes in liver function tests, which will be closely monitored. As with any medication, there is a risk of allergic reactions. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06200207?

Ask your doctor if Ziltivekimab is appropriate for you and what the potential benefits and risks are. Participation involves monthly injections for about 16 months, with regular check-ups and tests to monitor your health and the drug's effects. You will need to be able to perform a 6-minute walk test and complete quality of life questionnaires. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06200207 signal from an investment perspective?

This Phase 3 trial for Ziltivekimab, a novel anti-inflammatory drug for heart failure, signals significant investment in a large patient population with unmet needs, suggesting a potentially high prob This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participants will receive either Ziltivekimab or a placebo injection once a month for about a year. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.