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Pulmonary HypertensionPhase 2NCT05612035

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 2 study testing Frespaciguat in people with Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease, run by Merck Sharp & Dohme LLC at 85 sites in 19 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 85 years
What is being tested?
Frespaciguat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
129 participants
Where
85 sitesin 19 countries
Study dates
16 Mar 2023to 8 Oct 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has Group 3.1 pulmonary hypertension chronic obstructive pulmonary disease (PH-COPD) as defined by the Clinical Classification of Pulmonary Hypertension.
  • Has a right heart catheterization (RHC) at screening or historical RHC within 12 months before screening that meets hemodynamic criteria.
  • Has a physician diagnosis of obstructive lung disease on pulmonary function testing (PFT) performed at screening.
  • Has a WHO Functional Class assessment of Class II to IV.
  • If on supplemental oxygen, the regimen must be stable.
  • Has stable and optimized chronic, baseline COPD-specific therapy.
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  • If on PDE5 inhibitor, has stable concomitant use (initiated at least 3 months prior to randomization and no change in drug or dosage for at least 3 months prior to randomization) and changes to PDE5 inhibitor dosing is not anticipated during the 24 week Base Period.
  • If on antihypertensives and/or a diuretic regimen has stable concomitant use.
  • If on anticoagulants has stable concomitant use.
  • Is of any sex/gender from 40 to 85 years of age inclusive.
  • Female is not pregnant or breastfeeding, and is not of childbearing potential or uses acceptable contraceptive method or abstains from sexual intercourse, or has a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention, or whose history and sexual activity has been reviewed by the investigator.

Who cannot join

  • Has Group 1 pulmonary arterial hypertension (PAH), Groups 2, 4 or 5 pulmonary hypertension (PH).
  • Has non-COPD related Group 3 PH.
  • Has evidence of untreated more than mild obstructive sleep apnea.
  • Has significant left heart disease.
  • Expects to receive a lung and/or heart transplant from screening through the end of the 24 week Base Period.
  • Has evidence of a resting oxygen saturation (SpO2) < 88%.
Show all 17Show fewer
  • Has experienced a moderate or severe COPD exacerbation within 2 months before randomization.
  • Has experienced right heart failure within 2 months before randomization.
  • Has uncontrolled tachyarrhythmia.
  • Has acute coronary syndrome, undergone coronary artery bypass graft, or percutaneous coronary intervention within 2 months before randomization.
  • Has evidence of significant chronic renal insufficiency.
  • Has evidence of chronic liver disease, portal hypertension, cirrhosis, or hepatic abnormalities.
  • Initiated a pulmonary rehabilitation program within 2 months before randomization.
  • Has impairments that limit the ability to perform 6MWT.
  • Has history of cancer.
  • Is a user of illicit drugs or has a recent history of drug/alcohol abuse or dependence.
  • Has used PAH-specific therapies within 2 months of randomization.

Trial locations and contacts

85 sites in 19 countries.

85 sites in 19 countries

United States18 sites

  • University of New Mexico Hospital ( Site 0146)

    Albuquerque, New Mexico, 87106

  • University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 0101)

    Aurora, Colorado, 80045

  • UNC Health - Eastowne Medical Office-Clinical Trials Unit ( Site 0147)

    Chapel Hill, North Carolina, 27514

  • University of Virginia Health System-Division of Pulmonary and Critical Care Medicine ( Site 0111)

    Charlottesville, Virginia, 22908

  • UT Southwestern Medical Center ( Site 0114)

    Dallas, Texas, 75390

  • Alexian Brothers Medical Center-Pulmonary ( Site 0109)

    Elk Grove Village, Illinois, 60007

  • Corewell Health ( Site 0133)

    Grand Rapids, Michigan, 49546

  • The University of Texas Health Science Center at Houston ( Site 0105)

    Houston, Texas, 77030

  • University of Iowa ( Site 0103)

    Iowa City, Iowa, 52242

  • University of Kansas Medical Center-IM-Pulmonary and Critical Care Medicine ( Site 0102)

    Kansas City, Kansas, 66160

  • Lexington VA Medical Center - Cooper Division ( Site 0137)

    Lexington, Kentucky, 40502

  • Intermountain Medical Center-Division of Pulmonary & Critical Care Medicine ( Site 0140)

    Murray, Utah, 84107

  • Creighton University Clinical Research Office ( Site 0123)

    Omaha, Nebraska, 68124

  • Temple University Hospital ( Site 0104)

    Philadelphia, Pennsylvania, 19140

  • UPMC Montefiore University Hospital-Department of Medicine ( Site 0149)

    Pittsburgh, Pennsylvania, 15213

  • Mayo Clinic in Rochester, Minnesota ( Site 0131)

    Rochester, Minnesota, 55905

  • UCSF Helen Diller Medical Center at Parnassus Heights ( Site 0110)

    San Francisco, California, 94143

  • Clinovation Intl. Corp. ( Site 0108)

    Sebring, Florida, 33870

Other trials in United States

Argentina5 sites

  • Fundación Respirar ( Site 0305)

    CABA, Buenos Aires, C1426ABP

  • Hospital Britanico de Buenos Aires ( Site 0307)

    CABA, C1280AEB

  • Hospital Privado Universitario de Córdoba-Clinical Cardiology Department ( Site 0302)

    Córdoba, X5016KEH

  • Centro Medico Capital ( Site 0301)

    La Plata, Buenos Aires, 1904

  • Instituto de Cardiologia de Tucuman-Area de Investigacion Clinica ( Site 0303)

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Australia5 sites

  • WESLEY RESEARCH INSTITUTE Limited ( Site 0906)

    Auchenflower, Queensland, 4066

  • The Prince Charles Hospital ( Site 0904)

    Brisbane, Queensland, 4032

  • Royal Prince Alfred Hospital-Department of Respiratory Medicine ( Site 0903)

    Camperdown, New South Wales, 2050

  • Mater Misericordiae Limited ( Site 0905)

    South Brisbane, Queensland, 4101

  • Westmead Hospital ( Site 0902)

    Westmead, New South Wales, 2145

Other trials in Australia

France5 sites

  • CHU Angers ( Site 1506)

    Angers, Maine-et-Loire, 49933

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1501)

    Le Kremlin-Bicêtre, Paris, 94270

  • C.H.U Hôpital Nord ( Site 1503)

    Marseille, Bouches-du-Rhone, 13915

  • Centre Hospitalier Universitaire de Poitiers ( Site 1505)

    Poitiers, Vienne, 86021

  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1502)

    Vandœuvre-lès-Nancy, Lorraine, 54511

Other trials in France

Germany5 sites

  • Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1601)

    Dresden, Saxony, 01307

  • UKGM Gießen/Marburg ( Site 1604)

    Giessen, Hesse, 35392

  • Medizinische Hochschule Hannover ( Site 1602)

    Hanover, Lower Saxony, 30625

  • Thoraxklinik-Heidelberg gGmbH-Zentrum für Pulmonale Hypertonie ( Site 1603)

    Heidelberg, Baden-Wurttemberg, 69126

  • Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 1605)

    Lübeck, Schleswig-Holstein, 23538

Other trials in Germany

Spain5 sites

  • HOSPITAL CLÍNIC DE BARCELONA ( Site 2001)

    Barcelona, Catalonia, 08036

  • Parc de Salut Mar - Hospital del Mar ( Site 2006)

    Barcelona, 08003

  • Hospital Universitari Vall d'Hebron ( Site 2002)

    Barcelona, 08035

  • Hospital Universitario Marqués de Valdecilla-Pneumology ( Site 2003)

    Santander, Cantabria, 39008

  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2005)

    Seville, 41013

Other trials in Spain

Turkey (Türkiye)5 sites

  • Hacettepe Universite Hastaneleri ( Site 2301)

    Ankara, 06230

  • Ankara Bilkent Şehir Hastanesi. ( Site 2307)

    Ankara, 06800

  • Ankara University Health Practice and Research Hospitals ( Site 2310)

    Ankara, 6100

  • Eskisehir Osmangazi University-Cardiology ( Site 2304)

    Eskişehir, 26480

  • Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi-Chest Disease ( Site 2302)

    Istanbul, 34093

Other trials in Turkey (Türkiye)

Colombia4 sites

  • Ciensalud Ips S A S ( Site 0508)

    Barranquilla, Atlántico, 080001

  • Fundación Valle del Lili ( Site 0509)

    Cali, Valle del Cauca Department, 760032

  • Centro de Investigaciones Clinicas SAS ( Site 0505)

    Cali, Valle del Cauca Department, 760036

  • Clinica Cardio VID ( Site 0504)

    Medellín, Antioquia, 050034

Other trials in Colombia

Guatemala4 sites

  • Unidad De Diagnostico Cardiologico-Unidad de Diagnostico Cardiologico ( Site 0605)

    Guatemala City, 01001

  • MEDI-K ( Site 0607)

    Guatemala City, 01009

  • Clinica Medica ( Site 0601)

    Guatemala City, 01010

  • Private Practice - Dr. Jeremias Guerra Mejia ( Site 0603)

    Guatemala City, 01010

Other trials in Guatemala

Mexico4 sites

  • INVECORDIS S.C. ( Site 0703)

    Hacienda de Las Palmas, State of Mexico, 52787

  • Instituto Nacional de Cardiologia Ignacio Chavez ( Site 0701)

    México, 14080

  • Centro Médico Nacional Siglo XXI ( Site 0708)

    Mexico City, Mexico City, 06760

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0704)

    Mexico City, Mexico City, 14080

Other trials in Mexico

South Africa4 sites

  • TREAD Research ( Site 2101)

    Cape Town, Western Cape, 7500

  • Netcare St Augustine's Hospital ( Site 2105)

    Durban, KwaZulu-Natal, 4001

  • Charlotte Maxeke Johannesburg Academic Hospital ( Site 2108)

    Johannesburg, Gauteng, 2193

  • Netcare Milpark Hospital ( Site 2103)

    Johannesburg, Gauteng, 2193

Other trials in South Africa

South Korea4 sites

  • Gachon University Gil Medical Center ( Site 1101)

    Namdong-gu, Incheon, 21565

  • Seoul National University Hospital ( Site 1103)

    Seoul, 03080

  • Asan Medical Center ( Site 1102)

    Seoul, 05505

  • Samsung Medical Center ( Site 1104)

    Seoul, 06355

Other trials in South Korea

Italy3 sites

  • Ospedale San Gerardo-ASST Monza-Cardio Vasolare- Clinica pneumologica ( Site 1802)

    Monza, Lombardy, 20900

  • ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione ( Site 1804)

    Palermo, 90127

  • Cattinara Hospital ( Site 1801)

    Trieste, Friuli Venezia Giulia, 34149

Other trials in Italy

Peru3 sites

  • Unidad de Investigacon de la Clinica Internacional ( Site 0804)

    Lima Cercado, Lima region, 15001

  • Clinica Ricardo Palma-Centro de Investigacion de Enfermedades Respiratorias Thorax ( Site 0806)

    San Isidro, Lima region, 15036

  • Clínica Providencia ( Site 0803)

    San Miguel, Lima region, 15088

Other trials in Peru

Switzerland3 sites

  • University Hospital Basel ( Site 2205)

    Basel, Canton of Basel-City, 4031

  • Cantonal Hospital St.Gallen ( Site 2203)

    Sankt Gallen, 9007

  • UniversitätsSpital Zürich ( Site 2201)

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Austria2 sites

  • Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1201)

    Graz, Styria, 8036

  • Medizinische Universitaet Innsbruck ( Site 1202)

    Innsbruck, Tyrol, 6020

Other trials in Austria

Belgium2 sites

  • Université Libre de Bruxelles - Hôpital Erasme ( Site 1302)

    Brussels, Bruxelles-Capitale, Region de, 1070

  • UZ Leuven ( Site 1301)

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

Israel2 sites

  • Rambam Health Care Campus ( Site 1701)

    Haifa, 3109601

  • Rabin Medical Center ( Site 1702)

    Petah Tikva, 4941 492

Other trials in Israel

United Kingdom2 sites

  • Hammersmith Hospital-Department of Cardiology ( Site 2401)

    London, London, City of, W12 OHS

  • Sheffield Teaching Hospitals NHS Foundation Trust-Clinical Research Facility ( Site 2405)

    Sheffield, S10 2JF

Other trials in United Kingdom

About this study

Official title: 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

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.

Being tested
Frespaciguat, Placebo
Medical subject headings
Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FrespaciguatDrug

    Also called MK-5475

    Frespaciguat 380 µg administered as dry powder inhalation once daily.

  • PlaceboDrug

    Placebo administered as dry powder inhalation once daily.

Study groups in NCT05612035
Study groupRoleWhat they receive
FrespaciguatExperimentalParticipants with PH-COPD will receive 380 µg of frespaciguat as an oral inhalation once daily for 24 weeks (base period) and thereafter for up to 42 months (optional extension period).
Receives: Drug: Frespaciguat
PlaceboPlacebo comparatorParticipants with PH-COPD will receive matching placebo as an oral inhalation once daily for 24 weeks (base period) and then 380 µg of frespaciguat as an oral inhalation once daily for up to 42 months (optional extension period).
Receives: Drug: Frespaciguat; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    6MWD is assessed using the 6-minute walk test (6MWT).

    Measured: Baseline and Week 24

Secondary outcomes (7)

  1. Mean Change From Baseline in 6MWD at Week 12

    6MWD is assessed using the 6-minute walk test (6MWT).

    Measured: Baseline and Week 12

  2. Mean Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) at Week 12

    NT-proBNP was measured at baseline and Week 12.

    Measured: Baseline and Week 12

  3. Mean Change From Baseline in NT-ProBNP at Week 24

    NT-proBNP was measured at baseline and Week 24

    Measured: Baseline and Week 24

  4. Percentage of Participants Whose World Health Organization-Functional Class (WHO-FC) Does not Worsen Relative to Baseline at Week 12

    Participants are assigned one of four WHO-FC, dependent on limits of physical activity. As WHO-FC increases from I to IV, limits of physical activity increase.

    Measured: Baseline and Week 12

  5. Percentage of Participants Whose WHO-FC Does not Worsen Relative to Baseline at Week 24

    Participants are assigned one of four WHO-FC, dependent on limits of physical activity. As WHO-FC increases from I to IV, limits of physical activity increase.

    Measured: Baseline and Week 24

  6. Percentage of Participants With One or More Adverse Events (AEs)

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to Week 206

  7. Percentage of Participants who Discontinued Study Treatment due to an AE

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be presented.

    Measured: Up to Week 204

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2022
  2. Study start16 Mar 2023
  3. Primary completion9 Apr 2026
  4. Study completion8 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05612035
Sponsor's protocol ID
5475-013
Other IDs
MK-5475-013, 2022-501201-13-00, U1111-1279-8512
Status last verified
Apr 2026
First submitted
3 Nov 2022
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Frespaciguat in people with Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease, run by Merck Sharp & Dohme LLC at 85 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Argentina, Australia, France, Germany and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in 6-minute Walk Distance (6MWD) at Week 24 (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05612035.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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