Frespaciguat (MK-5475) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD) (MK-5475-006)

Summary

The primary objectives of this study are to assess the safety/tolerability and efficacy (by evaluating changes in pulmonary vascular resistance \[PVR\] and pulmonary blood volume \[PBV\]) of frespaciguat in participants with pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD). The primary hypothesis is that 28 days of frespaciguat treatment is superior to placebo treatment in reduction of PVR.

Timeline

Start

2020-06-05

Primary completion

2022-01-12

Completion

2022-01-12

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper with between-group difference in PVR less than -15% and calculated PP of 51%. PMID 38803412 ↗

paper MK-5475 versus placebo led to numerical improvements from baseline in PVR PMID 38803412 ↗

Publications

• Results Bajwa EK, Cislak D, Kumar A, Li D, Messina EJ, Reynders T, Denef JF, Corcea V, Buch KP, Lai E, Stoch SA. Phase 1 Study of MK-5475, an Inhaled Soluble Guanylate Cyclase Stimulator, in Participants with Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2024 May 23;19:1105-1121. doi: 10.2147/COPD.S454905. eCollection 2024.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Frespaciguat	Small molecule	32 ug	Inhaled
Subject	Frespaciguat	Small molecule	100 ug	Inhaled
Subject	Frespaciguat	Small molecule	195 ug	Inhaled
Subject	Frespaciguat	Small molecule	360 ug	Inhaled
Subject	Frespaciguat	Small molecule	380 ug	Inhaled

Indications