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Soluble Guanylate Cyclase Stimulator

MK-5475 for Pulmonary Arterial Hypertension

Phase 2 & 3
Recruiting
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Heritable PAH
World Health Organization functional class (WHO-FC) symptoms between Class II and IV.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2.25 years
Awards & highlights

Study Summary

This trial is testing a new drug, MK-5475, to see if it can help people with pulmonary arterial hypertension. There will be two parts to the trial. In the first part, different doses of the drug will be tested against a placebo to see if there are any benefits. The second part of the trial will be a longer study to confirm the results of the first part.

Who is the study for?
This trial is for adults with pulmonary arterial hypertension (PAH) who can walk between 150 and 500 meters in six minutes. They must have a specific diagnosis of PAH confirmed by heart catheterization, be on stable PAH therapy, not pregnant or breastfeeding, and agree to use contraception. Excluded are those with severe kidney or liver disease, current smokers, low oxygen levels even with support, significant heart disease other than PAH, untreated sleep apnea or certain cancer histories.Check my eligibility
What is being tested?
The study tests MK-5475—an inhaled drug stimulating an enzyme linked to blood vessel relaxation—against a placebo. Phase 2 explores three doses over 12 weeks to find the best one based on safety and ability to reduce lung blood pressure. Phase 3 confirms this dose's effectiveness over another 12 weeks plus up to five years extension by measuring walking distance improvements.See study design
What are the potential side effects?
While the side effects of MK-5475 aren't detailed here, similar drugs often cause headaches, dizziness due to low blood pressure, nausea or upset stomachs; some may experience allergic reactions or worsening symptoms related to their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have inherited pulmonary arterial hypertension.
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My symptoms are moderate to severe but not the most severe.
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My pulmonary hypertension is caused by drugs or toxins.
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I am not pregnant or breastfeeding.
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I have high blood pressure in the lungs due to one of several specific causes.
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My PAH is due to connective tissue disease, HIV, or heart birth defects.
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I have high blood pressure in the lungs without a known cause.
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I have PAH confirmed by a specific heart test showing certain pressure levels.
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I can walk between 150 and 500 meters in 6 minutes.
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My PAH diagnosis was confirmed with a heart catheter test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2.25 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2.25 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 2 Cohort: Change from Baseline in Pulmonary Vascular Resistance (PVR) at 12 Weeks
Phase 3 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 12 Weeks
Secondary outcome measures
Phase 2 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 12 Weeks
Phase 2 Cohort: Change from Baseline in Cardiac Index (CI) at 12 weeks
Phase 2 Cohort: Change from Baseline in Mean Right Arterial Pressure (mRAP) at 12 Weeks
+7 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 3 Cohort MK-5475Experimental Treatment1 Intervention
Participants receive one of 3 MK-5475 doses (380, 100 or 32 µg) to be selected at end of the Phase 2 Cohort, administered via oral inhalation once daily for 12-week base period and up to 60 months in the extension period
Group II: Phase 2 Cohort MK-5475 380 µgExperimental Treatment1 Intervention
Participants receive MK-5475 380 µg via oral inhalation once daily for 12 week base period and for optional 24 month extension period.
Group III: Phase 2 Cohort MK-5475 32 µgExperimental Treatment1 Intervention
Participants receive MK-5475 32 µg via oral inhalation once daily for 12 week base period and for optional 24 month extension period.
Group IV: Phase 2 Cohort MK-5475 100 µgExperimental Treatment1 Intervention
Participants receive MK-5475 100 µg via oral inhalation once daily for 12 week base period and for optional 24 month extension period.
Group V: Phase 2 Cohort PlaceboPlacebo Group1 Intervention
Participants receive placebo via oral inhalation once daily for 12 week base period, and one of the MK-5475 doses (380, 100, or 32 µg) for the optional 24 month extension period.
Group VI: Phase 3 Cohort PlaceboPlacebo Group1 Intervention
Participants receive placebo via oral inhalation once daily for 12 week base period and up to 60 months in the extension period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-5475
2019
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,685 Total Patients Enrolled
4 Trials studying Pulmonary Arterial Hypertension
80 Patients Enrolled for Pulmonary Arterial Hypertension
Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,060,221 Total Patients Enrolled
11 Trials studying Pulmonary Arterial Hypertension
683 Patients Enrolled for Pulmonary Arterial Hypertension
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,290 Total Patients Enrolled
11 Trials studying Pulmonary Arterial Hypertension
1,904 Patients Enrolled for Pulmonary Arterial Hypertension

Media Library

MK-5475 (Soluble Guanylate Cyclase Stimulator) Clinical Trial Eligibility Overview. Trial Name: NCT04732221 — Phase 2 & 3
Pulmonary Arterial Hypertension Research Study Groups: Phase 3 Cohort MK-5475, Phase 2 Cohort Placebo, Phase 2 Cohort MK-5475 380 µg, Phase 2 Cohort MK-5475 100 µg, Phase 2 Cohort MK-5475 32 µg, Phase 3 Cohort Placebo
Pulmonary Arterial Hypertension Clinical Trial 2023: MK-5475 Highlights & Side Effects. Trial Name: NCT04732221 — Phase 2 & 3
MK-5475 (Soluble Guanylate Cyclase Stimulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04732221 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please explain how many research facilities are testing this hypothesis?

"This trial is enrolling patients at various hospitals and medical centres across North America, including University Health Network - Toronto General Hospital (Site 0104) in Toronto, Ontario, Norton Pulmonary Associates (Site 0048) in Louisville, Kentucky, and Indiana University Health Methodist Hospital (Site 0045) in Indianapolis, Indiana."

Answered by AI

What are the aims of this research?

"The primary focus of this study, which will be observed at baseline and 12 weeks, is the change in 6-Minute Walk Distance (6MWD) among the Phase 3 cohort at 12 weeks. Additionally, the study will also monitor the Phase 3 cohort's number of participants who discontinue the study drug due to an adverse event, the Phase 2 cohort's change from baseline in Cardiac Index (CI) at 12 weeks, and the Phase 2 cohort's number of participants who experience an adverse event."

Answered by AI

Does this research project have an age limit for participants?

"The parameters for this study state that potential participants must be aged 18 to 75. Out of the 759 total clinical trials, 58 are for minors and 701 are for adults over the age of 65."

Answered by AI

Who would be an ideal candidate for this type of treatment?

"This clinical trial is looking for 450 participants who have pulmonary arterial hypertension and are between the ages of 18 and 75. Other requirements for potential patients include: a right heart catheterization documenting their PAH, a Pulmonary vascular resistance of ≥3 Wood units, being diagnosed with idiopathic PAH, heritable PAH, drug or toxin-induced PAH, PAH associated with connective tissue disease, HIV infection, or congenital heart disease, a mean pulmonary artery pressure of ≥25 mmHg, a pulmonary capillary wedge pressure or left ventricular end diastolic pressure of ≤15 mmHg,"

Answered by AI

Are there any current openings in this trial for new test subjects?

"That is correct. The clinical trial in question, which was first advertised on May 19th, 2021, is recruiting participants. 450 individuals are needed in total, with 23 different medical centres across the country looking for patients."

Answered by AI

To date, how many people have signed up to be a part of this clinical trial?

"That is correct, the information on clinicaltrials.gov does say that this trial is actively recruiting patients. This particular trial was posted on May 19th, 2021 and was updated on October 14th, 2022. The aim is to recruit 450 patients from 23 different locations."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Kentucky
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
University of Kentucky ( Site 0006)
Recent research and studies
clinicaltrials.govStudy
A Study of the Efficacy and Safety of MK-5475 in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007)
2021. "A Study of the Efficacy and Safety of MK-5475 in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04732221.
All > Pulmonary Arterial Hypertension > Pulmonary Hypertension
~169 spots leftby Feb 2026
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