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Study on the Safety and Effectiveness of MK-5475 for Adults with Pulmonary Hypertension and COPD

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What is this trial about?

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

This clinical trial is focused on studying a condition called Pulmonary Hypertension associated with Chronic Obstructive Pulmonary Disease (PH-COPD). Pulmonary Hypertension is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. Chronic Obstructive Pulmonary Disease is a chronic inflammatory lung disease that causes obstructed airflow from the lungs. The study is testing a new treatment called MK-5475, which is an inhalation powder, to see if it can help improve the condition of people with PH-COPD. Some participants will receive MK-5475, while others will receive a placebo, which looks like the treatment but does not contain the active substance.

The purpose of the study is to evaluate the effect of MK-5475 on the distance participants can walk in six minutes, known as the 6-minute walk distance, after 24 weeks. Participants will be randomly assigned to receive either MK-5475 or a placebo. The study will last for several months, during which participants will have regular check-ups to monitor their health and the effects of the treatment. The study aims to see if MK-5475 can help improve the ability to walk longer distances and assess its safety for people with PH-COPD.

Throughout the study, participants will be closely monitored for any changes in their condition and any side effects they might experience. The study will also look at other health indicators, such as levels of a substance called N-terminal pro B-type natriuretic peptide (NT-proBNP), which can be a marker of heart stress, and the overall health status of participants as classified by the World Health Organization (WHO). The goal is to gather information that could lead to better treatment options for people living with PH-COPD.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of the trial
Upon joining the study, you will be randomly assigned to receive either the study medication, MK-5475, or a placebo. A placebo is a substance with no active medication, used to compare effects.
The medication is administered as an inhalation powder. You will be instructed on how to use the inhalation device properly.
Step 2
Medication schedule
You will take the assigned medication through inhalation. The specific dosage and frequency will be provided by the study team.
The duration of the medication administration is planned for up to 24 weeks, with regular monitoring and assessments throughout this period.
Step 3
Regular assessments
Throughout the trial, you will undergo regular assessments to monitor your health and the effects of the medication. This includes measuring your ability to walk for six minutes, known as the 6-minute walk distance (6MWD).
Additional tests may include blood tests to measure specific markers related to your condition.
Step 4
Mid-trial evaluation
At approximately 12 weeks into the trial, there will be a mid-trial evaluation. This will include a review of your 6-minute walk distance and other health markers.
The study team will assess any changes in your condition and any side effects you may be experiencing.
Step 5
End of trial evaluation
At the end of the 24-week period, a final evaluation will be conducted. This will include a comprehensive review of your health, the 6-minute walk distance, and other relevant health markers.
The study team will discuss the overall findings with you and provide guidance on any next steps.

Who can join the trial?

11 criteria

The patient must have **pulmonary hypertension** associated with **chronic obstructive pulmonary disease (PH-COPD)**. This means they have high blood pressure in the lungs related to a long-term lung disease that makes it hard to breathe.
The patient can be of any **sex/gender** and must be between **40 to 85 years old**.
If the patient is a **female**, she must not be pregnant or breastfeeding. She should either not be able to have children, use an acceptable method of birth control, abstain from sexual intercourse, or have a negative pregnancy test within 24 hours before the first dose of the study medication. The doctor will review her medical history and sexual activity.
The patient must have had a **right heart catheterization (RHC)**, which is a test to check the pressure in the heart and lungs, either at the start of the study or within the last 12 months, and it must meet certain criteria.
The patient must show signs of **obstructive lung disease** on a **pulmonary function test (PFT)** done at the start of the study. This test measures how well the lungs are working.
The patient must have a **WHO Functional Class** of **Class II to IV**, which is a way to describe how much the disease affects their daily life and activities.
If the patient uses **supplemental oxygen**, the amount and schedule must be stable.
The patient must have a stable and optimized treatment plan for their **chronic COPD**.
If the patient is taking a **PDE5 inhibitor**, which is a type of medication, its use must be stable.
If the patient is taking **antihypertensives** (medications to lower blood pressure) and/or a **diuretic regimen** (medications to help remove excess fluid from the body), their use must be stable.
If the patient is taking **anticoagulants** (medications to prevent blood clots), their use must be stable.

Who cannot join the trial?

10 criteria

Patients with any other type of **pulmonary hypertension** (high blood pressure in the lungs) not associated with **chronic obstructive pulmonary disease (COPD)** cannot participate.
Patients who have had a **heart attack** or **stroke** in the last 6 months are excluded.
Patients with **uncontrolled high blood pressure** (hypertension) are not eligible.
Patients with **severe liver disease** cannot take part in the study.
Patients with **kidney disease** requiring dialysis are excluded.
Patients who are **pregnant** or **breastfeeding** cannot participate.
Patients who have participated in another clinical trial within the last 30 days are not eligible.
Patients with a history of **drug or alcohol abuse** in the past year are excluded.
Patients with **cancer** that is not in remission are not eligible.
Patients with **severe mental health disorders** that are not well controlled cannot participate.

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Verified sites

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Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
Responsive
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Barcelona, Spain
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium

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Investigated drugs

MK-5475 is a medication being studied for its potential to help people with pulmonary hypertension, which is high blood pressure in the lungs, associated with chronic obstructive pulmonary disease (COPD). This medication is being tested to see if it can improve how far a person can walk in six minutes, which is a common way to measure how well someone with lung problems can function in daily life. The goal is to see if this medication can help improve breathing and overall physical activity in people with this condition.

3-(4-{(5S)-4-Amino-2-[6-Chloro-1-(3,3,4,4,4-Pentafluorobutyl)-1H-Indazol-3-Yl]-5-Methyl-6-Oxo6,7-Dihydro-5H-Pyrrolo[2,3-D]Pyrimidin-5-Yl}Phenyl)Propanoic Acid

What is already known about the treatment

MK-5475 – MK-5475 is administered as a medication for pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD). It is currently being studied in a Phase 2a clinical trial to assess its effectiveness and safety, with a focus on improving the distance patients can walk in six minutes after 24 weeks of treatment. The medication works by targeting specific pathways in the body to help relax and widen blood vessels in the lungs, which can lower blood pressure and improve breathing. MK-5475 is classified as a treatment for pulmonary hypertension, aiming to enhance the quality of life for individuals with this condition.

Investigated diseases

Pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD) – This condition involves high blood pressure in the arteries of the lungs, which is linked to chronic obstructive pulmonary disease. It occurs when the small blood vessels in the lungs become narrowed, blocked, or destroyed, leading to increased resistance to blood flow. As a result, the heart must work harder to pump blood through the lungs, which can lead to heart strain. Over time, this increased pressure can cause the right side of the heart to enlarge and weaken. Symptoms may include shortness of breath, fatigue, dizziness, and swelling in the ankles or legs. The progression of the disease can vary, with symptoms potentially worsening over time.