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sGC Stimulator

Inhaled sGC Stimulator for Pulmonary Hypertension and COPD

Phase 2

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 104

Summary

This trial will assess if a medication called MK-5475 can safely improve walking and exercise capacity in people with Pulmonary Hypertension associated with COPD. #COPD #PulmonaryHypertension

Who is the study for?

Adults aged 40-85 with Pulmonary Hypertension associated with Chronic Obstructive Pulmonary Disease (PH-COPD) can join this trial. They must have stable oxygen, anticoagulant, and COPD therapy regimens, and not be pregnant or planning a transplant. Exclusions include significant heart disease, recent severe COPD exacerbations, certain past medical conditions like cancer or drug abuse.

What is being tested?

The study tests the effectiveness of MK-5475 (an inhaled sGC stimulator) against a placebo in improving walking distance over six minutes after 24 weeks. Participants will use MK-5475 daily through inhalation to see if it helps better than a non-active treatment.

What are the potential side effects?

While specific side effects for MK-5475 are not listed here, common ones for new respiratory treatments may include coughing, throat irritation, headache, nausea and potential allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 104

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 104

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 104 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Change From Baseline in 6-minute Walk Distance (6MWD) at Week 24

Secondary study objectives

Mean Change From Baseline in 6MWD at Week 12

Nesiritide

Mean Change From Baseline in NT-ProBNP at Week 24

+4 more

Side effects data

From 2022 Phase 1 trial • 22 Patients • NCT04370873

33%

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Placebo (Part 2)

MK-5475 360 µg (Part 1)

Placebo (Part 1)

MK-5475 380 µg (Part 2)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MK-5475Experimental Treatment1 Intervention

Participants with PH-COPD will receive 380 µg of MK-5475 as an oral inhalation once daily for 24 weeks (base period) and thereafter for 18 months (optional extension period).

Group II: PlaceboPlacebo Group2 Interventions

Participants with PH-COPD will receive matching placebo as an oral inhalation once daily for 24 weeks (base period) and then 380 µg of MK-5475 as an oral inhalation once daily for 18 months (optional extension period).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-5475

2019

Completed Phase 3

~220

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