PF-07868489 for Pulmonary Hypertension

Recruiting at 65 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Pfizer

Must be taking: PAH vasodilators

Disqualifiers: Smoking, Major surgery, Allergic reactions, others

Compensation: Varies

Number of Visits: 7

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, PF-07868489, for individuals with pulmonary arterial hypertension (PAH), a condition characterized by high blood pressure in the lungs' arteries. The study evaluates the treatment's tolerance and mechanism in the body. It consists of two parts: one for healthy adults to assess safety with a single dose, and another for those with PAH to test multiple doses over 24 weeks. Individuals with PAH who have been stable on their current medication might be suitable candidates. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment functions in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in PAH treatment.

Do I need to stop my current medications to join the trial?

The trial requires participants with pulmonary arterial hypertension to be on a stable dose of their current PAH medications. The protocol does not specify if other medications need to be stopped.

Is there any evidence suggesting that PF-07868489 is likely to be safe for humans?

Research shows that PF-07868489 is still under investigation to determine its safety for people with pulmonary arterial hypertension (PAH). Previous studies tested the treatment to assess its tolerability and potential effects. Some trials reported side effects such as bleeding, irregular heartbeats, and lung problems.

The current trials are in the early stages. Researchers aim to learn more about the treatment, but they do not yet have complete information on its safety. This is typical of early studies, where the focus is on understanding how a new medicine works in the body and whether it causes any unwanted effects. Anyone considering joining a trial should consult a healthcare provider to weigh the potential risks and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pulmonary hypertension?

Unlike the standard treatments for pulmonary hypertension, which often include oral medications like endothelin receptor antagonists or phosphodiesterase-5 inhibitors, PF-07868489 is administered as a subcutaneous injection. This delivery method is unique because it allows for potentially more consistent absorption and effectiveness over time. Researchers are excited about PF-07868489 because it might offer a novel mechanism of action that could target the underlying causes of pulmonary hypertension more directly. This could translate to improved outcomes and a new avenue of hope for patients who do not respond well to existing treatments.

What evidence suggests that PF-07868489 might be an effective treatment for pulmonary hypertension?

Research shows that PF-07868489 is under investigation in this trial to determine its potential benefits for people with pulmonary arterial hypertension (PAH). Participants will receive either PF-07868489 or a placebo. The drug aims to affect specific processes in the body that contribute to PAH. Early results suggest it might help reduce pressure in the blood vessels connected to the lungs, a major concern in PAH. Although information on its effectiveness is still being gathered, the drug's design offers promise. Additional studies are underway to further understand its effects and safety. ^{1 2 3 4 6}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for healthy adults and those with pulmonary arterial hypertension (PAH), a type of high blood pressure affecting the lungs. Participants should have a BMI between 16 to 32 kg/m2 and weigh over 50 kg. It's not clear who can't join because the exclusion criteria are missing.

Inclusion Criteria

My BMI is between 16 and 32, and I weigh more than 50 kg.

Completely healthy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part A: Single Ascending Dose

An investigator- and participant-blind, sponsor-open, placebo-controlled, single ascending dose study to assess the safety, tolerability, and pharmacokinetics (PK) of PF-07868489 in healthy adult participants.

1 week

1 visit (in-person)

Part B: Repeat Doses

A 24-week, randomized, double blind, placebo-controlled study to assess the safety, tolerability, PK, and pharmacodynamics (PD) of PF-07868489 in adult participants with PAH.

24 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PF-07868489
• Placebo for PF-07868489

Trial Overview The study tests PF-07868489, which could potentially treat PAH. Part A involves giving healthy volunteers either this medicine or a placebo in increasing doses to check safety and how the body processes it. Part B gives PAH patients the drug or placebo for 24 weeks to assess safety and effectiveness.

How Is the Trial Designed?

Group I: PF-07868489 Experimental Treatment 1 Intervention

single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B)

Group II: Placebo Placebo Group 1 Intervention

single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B)

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

A multicenter, randomized, double-blind, placebo-controlled study evaluated the efficacy of ambrisentan in patients with inoperable chronic thromboembolic pulmonary hypertension, but the study was terminated early due to futility of enrollment.

Despite early termination, there were trends indicating that ambrisentan may improve primary and some secondary endpoints compared to placebo, with similar adverse event profiles between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambrisentan for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH). Escribano-Subias, P., Bendjenana, H., Curtis, PS., et al.[2020]

In a 24-week study involving 83 Chinese patients with pulmonary arterial hypertension (PAH), treatment with ambrisentan significantly improved exercise capacity, as measured by the 6-minute walk distance, with increases of 42.2 meters at week 12 and 53.4 meters at week 24 (P < 0.0001).

The study also found that 64.6% of patients experienced risk improvement within 24 weeks, and the median time to clinical improvement (TTCI) was 131 days, indicating that TTCI is a valuable endpoint for assessing treatment efficacy in PAH, as it is not influenced by baseline risk status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time to clinical improvement: an appropriate surrogate endpoint for pulmonary arterial hypertension medication trials. Wang, A., Chen, M., Zhuang, Q., et al.[2023]

The CAMPHOR questionnaire demonstrated better psychometric properties than the SF-36 in assessing patient-reported outcomes in individuals with pulmonary hypertension, based on a study of 65 participants.

CAMPHOR showed good reliability and the ability to distinguish between different World Health Organization functional classes, while the SF-36 had poor test-retest reliability and high ceiling effects in several domains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric performance of the CAMPHOR and SF-36 in pulmonary hypertension. Twiss, J., McKenna, S., Ganderton, L., et al.[2022]

In a study of 500 participants with pulmonary arterial hypertension (PAH), initial combination therapy with ambrisentan and tadalafil significantly reduced the risk of clinical failure events by 79% for patients with functional class II symptoms and by 42% for those with functional class III symptoms.

The combination therapy also notably decreased hospitalizations for worsening PAH, with no hospitalizations observed in functional class II patients receiving the combination treatment, suggesting that this approach is beneficial even for patients with less severe symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes stratified by baseline functional class after initial combination therapy for pulmonary arterial hypertension. White, RJ., Vonk-Noordegraaf, A., Rosenkranz, S., et al.[2020]

In the PATENT-1 study, riociguat significantly increased the proportion of patients with pulmonary arterial hypertension (PAH) achieving clinically relevant improvements in 6-minute walking distance (6MWD) and other key health indicators compared to placebo, with treatment-naïve patients showing a 21% increase in achieving 6MWD ≥380 m.

Riociguat also improved functional class and cardiac index in both treatment-naïve patients and those on background therapy, indicating its efficacy in enhancing overall patient outcomes in PAH management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of clinically relevant responder threshold criteria to evaluate the response to treatment in the phase III PATENT-1 study. Langleben, D., Galiè, N., He, J., et al.[2017]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06137742

NCT06137742 | A Study to Learn About the ... The purpose of the study is to learn how the study medicine called PF-07868489 is tolerated and acts in healthy adult people and people with pulmonary ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07073820?blm_aid=43981&rank=7

A Study to Learn About the Study Medicine (Called PF ... The purpose of this study is to learn about the long-term safety, tolerability and effects of the study medicine (PF-07868489) for the possible ...

3. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-pf-07868489-in-patients-with-pulmonary-arterial-hypertension/

Study on the Safety and Effects of PF-07868489 in Patients ... This clinical trial examines the tolerability and effects of PF-07868489, an investigational drug administered via injection, in patients with Pulmonary ...

4. isrctn.com isrctn.com/pdf/65235904

A study to learn how the study medicine called PF- ... A study to learn how the study medicine called PF-07868489 is tolerated and acts in people with pulmonary arterial hypertension. Who can ...

5. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/PFE/pressreleases/35741102/pfizers-new-study-on-pf-07868489-a-potential-game-changer-for-pulmonary-arterial-hypertension/

Pfizer's New Study on PF-07868489: A Potential Game- ... The study aims to assess the long-term safety, tolerability, and effects of PF-07868489, a potential treatment for pulmonary arterial ...

6. ucihealth.org ucihealth.org/clinical-trials/CCR-24-106

Study Description Learn How Study Medicine PF-07868489 is Tolerated and acts in Adult With Arterial Hypertension. UCI Specialty Areas: Cardiology, Pulmonology.