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PF-07868489

PF-07868489 is an investigational medication currently being studied for the treatment of Pulmonary Arterial Hypertension (PAH), a serious condition characterized by high blood pressure in the arteries that carry blood from the heart to the lungs. This high pressure makes it harder for the heart to pump blood through the lungs, potentially damaging the right side of the heart. Clinical trials are underway to evaluate the safety, effectiveness, and long-term benefits of PF-07868489, which is administered as a subcutaneous injection. These studies include both initial trials with healthy participants and patients with PAH, as well as extension studies that allow continued treatment to assess long-term outcomes.

Table of Contents

What is PF-07868489?

PF-07868489 is an investigational medication being studied for the treatment of Pulmonary Arterial Hypertension (PAH). It is currently in clinical trials to evaluate its safety, effectiveness, and how it works in the body. The medication is not yet approved by regulatory agencies and is only available to patients participating in clinical studies.[1] The drug is being developed as a potential new treatment option for people suffering from PAH, a serious condition affecting blood vessels in the lungs.

What is Pulmonary Arterial Hypertension?

Pulmonary Arterial Hypertension is a condition characterized by high blood pressure in the arteries that carry blood from the heart to the lungs. This increased pressure makes it harder for the heart to pump blood through the lungs, potentially causing damage to the right side of the heart. PAH is a serious and progressive condition that can significantly impact a person’s quality of life and survival.[1]

The symptoms of PAH may include:

  • Shortness of breath during routine activities
  • Fatigue or weakness
  • Chest pain or pressure
  • Dizziness or fainting
  • Swelling in the ankles, legs, or abdomen

How PF-07868489 is Administered

In clinical studies, PF-07868489 is administered through subcutaneous injections, which means the medication is injected just under the skin. Based on current research protocols, patients receive these injections:

  • In long-term studies: Every 4 weeks[1]
  • In initial studies: As single doses for healthy volunteers (Part A) or as 6 regular injections over time for PAH patients (Part B)[2]

The subcutaneous route of administration may offer convenience compared to some other PAH treatments that require continuous intravenous infusion or frequent oral dosing.

Clinical Studies of PF-07868489

PF-07868489 is being evaluated in multiple clinical trials to determine if it could be a safe and effective treatment for PAH. Current studies include:

Phase 1/2 Study: This study has two parts:[2]

  • Part A: Testing single ascending doses in healthy adult volunteers to assess safety, tolerability, and how the drug moves through the body (pharmacokinetics)
  • Part B: A 24-week, randomized, double-blind, placebo-controlled study in adults with PAH to assess safety, how the drug works (pharmacodynamics), and initial signs of effectiveness

Phase 2 Open-Label Extension Study: This study allows patients who participated in earlier PF-07868489 studies to continue receiving the medication for a longer period (up to 111 weeks) to gather information about long-term safety and effectiveness.[1]

In these studies, researchers carefully track how participants respond to the medication. Some participants receive PF-07868489, while others may receive a placebo (an injection with no active medication) for comparison, especially in the early phases of research.

Safety Monitoring

During the clinical trials, researchers closely monitor participants for any side effects or safety concerns. This monitoring includes:[1][2]

  • Treatment-emergent adverse events (AEs) and serious adverse events (SAEs) – any unfavorable and unintended signs, symptoms, or diseases that occur during the study
  • Laboratory tests to check blood counts, liver function, kidney function, and other body systems
  • Vital sign measurements such as blood pressure, heart rate, and temperature
  • Electrocardiogram (ECG) parameters to monitor heart function
  • Anti-drug antibody (ADA) development – to see if the body develops an immune response to the medication

This comprehensive monitoring helps researchers understand the safety profile of PF-07868489 and identify any potential risks associated with its use.

Expected Benefits

While the full benefits of PF-07868489 are still being investigated, researchers are measuring several indicators that might show improvement in PAH, including:[1][2]

  • N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) levels: This is a blood marker that can indicate the amount of strain on the heart. Lower levels may suggest improvement in heart function.
  • Other measurements of heart and lung function that may show improvement as treatment continues

If successful, PF-07868489 could potentially offer a new treatment option for people with PAH who may have limited alternatives or who don’t respond well to existing treatments.

Ongoing Research

Research on PF-07868489 is ongoing, with studies designed to answer important questions about the medication:[1][2]

  • Pharmacokinetics: How the drug is absorbed, distributed, metabolized, and eliminated from the body
  • Pharmacodynamics: How the drug affects the body and the underlying disease
  • Long-term safety: Whether the drug remains safe when used over extended periods
  • Efficacy: Whether the drug effectively improves symptoms and outcomes for people with PAH

The results of these studies will help determine whether PF-07868489 may eventually become an approved treatment option for PAH patients. Patients interested in learning more about this investigational treatment should speak with their healthcare providers about potential eligibility for clinical trials.

Study Aspect Details
Drug Name PF-07868489
Condition Studied Pulmonary Arterial Hypertension (PAH)
Administration Method Subcutaneous injection every 4 weeks
Study Types Phase 1/2 trials with healthy participants and PAH patients; Phase 2 open-label extension study
Study Designs Single ascending dose study (healthy adults); 24-week randomized, double-blind, placebo-controlled study (PAH patients); long-term open-label extension study
Primary Outcome Measures Safety (adverse events, laboratory tests, vital signs, ECG parameters); Changes in NT-proBNP levels
Secondary Outcome Measures Pharmacokinetics (how the drug moves through the body); Development of anti-drug antibodies
Study Duration Initial studies: up to 24 weeks of treatment with follow-up to Day 253; Extension study: measurements up to week 111 (over 2 years)

FAQ

  • What is PF-07868489? PF-07868489 is an investigational medicine being studied as a potential treatment for Pulmonary Arterial Hypertension (PAH). It is administered as a subcutaneous injection (under the skin) every 4 weeks. The drug is still in clinical trials to determine its safety and effectiveness for patients with PAH.
  • How is PF-07868489 administered in the clinical trials? In the clinical trials, PF-07868489 is administered as a subcutaneous injection, which means it is injected under the skin. In the extension study, participants receive doses every 4 weeks. The dosing schedule is designed to maintain appropriate levels of the medication in the body over time.
  • What types of clinical trials are being conducted with PF-07868489? There are multiple types of studies being conducted with PF-07868489. One is a Phase 1/2 study that includes both healthy adult participants (Part A) and people with PAH (Part B). This study evaluates safety, tolerability, and how the drug acts in the body. There is also a Phase 2 open-label extension study that allows participants from previous PF-07868489 trials to continue receiving the medication to assess long-term safety and effectiveness.
  • What are researchers measuring in these clinical trials? Researchers are measuring several important outcomes in these trials. Primary measures include the number of participants experiencing side effects (adverse events), changes in laboratory test results, vital sign abnormalities, and electrocardiogram (ECG) parameters. They are also tracking changes in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) levels, which is a marker for heart failure. Additionally, they're studying how the drug moves through the body (pharmacokinetics) and whether participants develop antibodies against the drug.
  • How long do the clinical trials for PF-07868489 last? The duration varies by trial. The Phase 1/2 study (NCT06137742) includes a 24-week treatment period for participants with PAH, with monitoring continuing up to approximately Day 253. The open-label extension study (NCT07073820) is designed to evaluate long-term effects, with measurements taken up to week 111, which is just over 2 years. This extended timeframe helps researchers understand the long-term safety and effectiveness of the medication.

Ongoing Clinical Trials on PF-07868489

  • A Study of PF-07868489 Safety and Effectiveness in Adults with Pulmonary Arterial Hypertension Who Participated in a Previous PF-07868489 Trial

    Recruiting

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    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Germany Greece Italy +1

  • Study on the Safety and Effects of PF-07868489 in Patients with Pulmonary Arterial Hypertension

    Recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Germany Greece Italy +1

Glossary

  • Pulmonary Arterial Hypertension (PAH): A condition in which there is high blood pressure in the arteries that carry blood from the heart to the lungs. This high pressure makes it harder for the heart to pump blood through the lungs, potentially damaging the right side of the heart.
  • Open-label study: A type of clinical trial where both the healthcare providers and the study participants know which treatment is being given. This is different from a blinded study where participants don't know if they're receiving the actual medication or a placebo.
  • Extension study: A clinical trial that allows patients from an earlier study to continue receiving the treatment to assess long-term benefits and safety of the medicine.
  • Subcutaneous injection: An injection that delivers medication under the skin rather than into a muscle or vein.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease that develops during treatment in a clinical trial, whether or not it is related to the treatment being studied.
  • Serious Adverse Events (SAEs): Adverse events that result in death, are life-threatening, require hospitalization or extension of existing hospitalization, result in persistent disability, or are otherwise medically significant.
  • N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP): A substance released into the bloodstream when the heart is under stress. Elevated levels can indicate heart failure or cardiac dysfunction. In PAH trials, changes in NT-proBNP are measured to assess the effect of treatment on heart function.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it is absorbed, distributed, metabolized, and excreted.
  • Pharmacodynamics (PD): The study of how a drug affects the body, including its mechanism of action and the relationship between drug concentration and effect.
  • Anti-Drug Antibody (ADA): Antibodies that the body produces against a therapeutic drug. The presence of these antibodies can potentially affect how well a treatment works or cause immune reactions.
  • Randomized study: A study in which participants are randomly assigned to different treatment groups, which helps reduce bias in the research results.
  • Double-blind study: A clinical trial design where neither the participants nor the researchers know who is receiving the actual treatment versus a placebo until the study is completed.
  • Placebo: An inactive substance that looks like the drug being tested but has no therapeutic effect. It's used as a comparison to evaluate the true effects of the investigational treatment.
  • Plasma concentration: The amount of drug present in the blood plasma (the liquid portion of blood) at a given time.
  • Cmin (Minimum Observed Plasma Trough Concentration): The lowest concentration of a drug in the blood, typically measured just before the next dose is administered.
  • Cmax (Maximum Observed Plasma Concentration): The highest concentration of a drug in the blood after administration.

References