NCT05612035 is a Phase 2 clinical trial of Frespaciguat in Pulmonary Hypertension, sponsored by Merck Sharp & Dohme LLC.

Who is sponsoring NCT05612035?

NCT05612035 is sponsored by Merck Sharp & Dohme LLC.

What drugs are being tested in NCT05612035?

Interventions in NCT05612035: Frespaciguat, Placebo.

What condition does NCT05612035 study?

NCT05612035 studies Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease.

Is NCT05612035 still recruiting?

NCT05612035 is currently active, enrolled. Last updated 13 April 2026.

Last reviewed 2026-04-13 · How we verify

NCT05612035

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 2 Last updated 13 April 2026

What this trial tests

Phase 2 trial testing Frespaciguat in Pulmonary Hypertension in 120 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

16 March 2023

Primary endpoint
7 April 2026

7 October 2029

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	120
Start date	16 March 2023
Primary completion	7 April 2026
Estimated completion	7 October 2029
Sites	85 locations across Italy, Colombia, South Korea, Guatemala, Belgium, Mexico, United States, France

Drugs / interventions tested

Frespaciguat — full drug profile →
Placebo

Conditions studied

Pulmonary Hypertension — all drugs for Pulmonary Hypertension →
Chronic Obstructive Pulmonary Disease — all drugs for Chronic Obstructive Pulmonary Disease →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 40 to 85, any sex, with Pulmonary Hypertension or Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Pulmonary hypertension associated with lung diseases.
Shlobin OA, Adir Y, Barbera JA, Cottin V, et al · · 2024 · cited 53× · PMID 39209469 · DOI 10.1183/13993003.01200-2024
Pathophysiology of Group 3 Pulmonary Hypertension Associated with Lung Diseases and/or Hypoxia.
Nakamura K, Akagi S, Ejiri K, Taya S, et al · · 2025 · cited 8× · PMID 39859549 · DOI 10.3390/ijms26020835
Phase 1 Study of MK-5475, an Inhaled Soluble Guanylate Cyclase Stimulator, in Participants with Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease.
Bajwa EK, Cislak D, Kumar A, Li D, et al · · 2024 · cited 7× · PMID 38803412 · DOI 10.2147/copd.s454905
Novel insights and new therapeutic potentials for macrophages in pulmonary hypertension.
Zuo Y, Li B, Gao M, Xiong R, et al · · 2024 · cited 7× · PMID 38555425 · DOI 10.1186/s12931-024-02772-8
The 10th International Conference on cGMP 2022: recent trends in cGMP research and development-meeting report.
Friebe A, Kraehling JR, Russwurm M, Sandner P, et al · · 2023 · cited 5× · PMID 37079081 · DOI 10.1007/s00210-023-02484-8
Chest Computed Tomography to Improve Phenotyping in Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease.
Johnson SW, Wan ES, San Jose Estépar R, Nardelli P, et al · · 2025 · cited 2× · PMID 39556097 · DOI 10.1513/annalsats.202408-878ps

Verify or expand the search:

Other trials of Frespaciguat

Trials testing the same drug.

NCT04732221 — A Study of the Efficacy and Safety of Frespaciguat (MK-5475) in Participants With Pulmonary Arterial Hypertension (INSIG · Phase 2, PHASE3 · completed
NCT04425733 — Frespaciguat (MK-5475) in Participants With Hypoxemia Due to COVID-19 Pneumonia (MK-5475-009) · Phase 1 · withdrawn
NCT04370873 — Frespaciguat (MK-5475) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease · Phase 1 · completed
NCT03744637 — A Study of Single Doses of Frespaciguat (MK-5475) on Pulmonary Vascular Resistance (MK-5475-002) · Phase 1 · completed

Other recruiting trials for Pulmonary Hypertension

Currently open trials in the same condition.

NCT07179380 — Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension · Phase 3 · recruiting
NCT07073820 — A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have P · Phase 2 · recruiting
NCT06351345 — 129 Xenon Imaging in Patients Treated With Sotatercept · Phase 2 · recruiting
NCT07187206 — Safety and Efficacy of FETO in CDH Phase III · Phase 3 · recruiting
NCT07206173 — Londrina Activities of Daily Living Protocol in Pulmonary Hypertension · recruiting

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005) · Phase 2 · not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05612035 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 13 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05612035.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing