NCT05612035

Frespaciguat (MK-5475) INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of Frespaciguat (an Inhaled sGC Stimulator) in Adults With PH-COPD

A Phase 2a Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic obstructive pulmonary disease (COPD). The goal of the study is to learn if people who take frespaciguat can walk farther in 6 minutes at Week 24 compared to people who take placebo.

Conditions

• Pulmonary Hypertension
• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Frespaciguat	Frespaciguat 380 µg administered as dry powder inhalation once daily.
DRUG	Placebo	Placebo administered as dry powder inhalation once daily.

Timeline

• Start date: 2023-03-16
• Primary completion: 2026-04-07
• Completion: 2029-10-07
• First posted: 2022-11-10
• Last updated: 2026-04-13

Locations

85 sites across 19 countries: United States, Argentina, Australia, Austria, Belgium, Colombia, France, Germany, Guatemala, Israel, Italy, Mexico, Peru, South Africa, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study