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New dosing strategy for PAH drug under study

NCT ID NCT06664801

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at two ways of giving the drug sotatercept to people with pulmonary arterial hypertension (PAH), a condition where lung blood vessels narrow, making it hard to breathe. Researchers compared a standard weight-based dose to a simpler weight-banded dose to see how the drug levels in the body and safety compare. 164 adults with PAH on usual treatments took part in this completed phase 2 trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

164 people

The number who actually took part.

Started

Nov 2024

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Has documented diagnostic Right Heart Catheterization, with the diagnosis of World Health Organization (WHO) Pulmonary Atrial Hypertension (PAH) Group 1 in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAH associated with connective tissue disease, PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair * Has symptomatic PAH classified as WHO Functional Class II or III Exclusion Criteria: * Has a weight of \<35 kg * Has a diagnosis of PH WHO Groups 2, 3, 4, or 5 * Has a diagnosis of the following PAH Group 1 subtypes: HIV-associated PAH, PAH associated with portal hypertension, Exclusion in PAH Group 1 should also include schistosomiasis-associated PAH, pulmonary veno occlusive disease and pulmonary capillary hemangiomatosis * Has uncontrolled systemic hypertension * Has a history of pneumonectomy * Has a history of known pericardial constriction * Has a history of restrictive cardiomyopathy * Has history of atrial septostomy (within 180 days prior to study start) * Has personal or family history of long QT syndrome * Has history of coronary artery disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass, graft surgery, or cardiac anginal chest pain) (within 6 months prior to study start) * Has a cerebrovascular accident (within 3 months prior to study start) * Has significant (\>2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease * Has untreated more than mild obstructive sleep apnea * Has known malignancy that is progressing or has required active treatment within the past 5 years * Has recently started (within 12 months prior to study start) or has plans to start weight loss medication or enter a weight loss program during the study period * Has a previous (within 3 years) or planned (during the study) obesity treatment with surgery or a weight-loss device

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary arterial hypertension

Contacts and locations

Locations

  • A.O.U. Citta della Salute e della Scienza di Torino ( Site 0904)

    Turin, Piedmont, 10126, Italy

  • AOU Policlinico Umberto I ( Site 0910)

    Rome, Lazio, 00161, Italy

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 0900)

    Milan, Lombardy, 20162, Italy

  • Asan Medical Center ( Site 1303)

    Seoul, 05505, South Korea

  • Ascension Seton Heart Specialty Care and Transplant Center ( Site 1918)

    Austin, Texas, 78705, United States

  • Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0500)

    Marseille, Bouches-du-Rhone, 13015, France

  • Azienda Ospedaliera Universitaria Integrata ( Site 0908)

    Verona, Veneto, 37126, Italy

  • CHU Bordeaux Haut-Leveque ( Site 0501)

    Pessac, Aquitaine, 33604, France

  • CHU Dijon Bourgogne ( Site 0502)

    Dijon, Cote-d Or, 21079, France

  • CHU GABRIEL MONTPIED ( Site 0504)

    Clermont-Ferrand, Puy-de-Dome, 63003, France

  • CHU de Rouen ( Site 0503)

    Rouen, Haute-Normandie, 76000, France

  • Carmel Hospital ( Site 0803)

    Haifa, 3436212, Israel

  • Centro Medico Capital ( Site 0002)

    La Plata, Buenos Aires, B1904AAW, Argentina

  • Centro de Investigaciones Clinicas SAS ( Site 0306)

    Cali, Valle del Cauca Department, 760036, Colombia

  • Centrum pro plicní hypertenzi VFN II. interni klinika VFN a 1. LF UK ( Site 0400)

    Prague, Praha 2, 128 08, Czechia

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0609)

    Berlin, 10117, Germany

  • Chonnam National University Hospital (CNUH) ( Site 1304)

    Gwangju, Kwangju-Kwangyokshi, 61469, South Korea

  • Clinica Cardio VID ( Site 0307)

    Medellín, Antioquia, 050034, Colombia

  • Clinica Colsanitas - Sede Reina Sofia ( Site 0303)

    Bogotá, Bogota D.C., 110111, Colombia

  • Clínica Imbanaco S.A.S ( Site 0304)

    Cali, Valle del Cauca Department, 760042, Colombia

  • Faculty of Medicine Siriraj Hospital ( Site 1600)

    Bangkok, Bangkok, 10700, Thailand

  • Fondazione G. Monasterio ( Site 0907)

    Pisa, 56124, Italy

  • Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0902)

    Milan, 20122, Italy

  • Fondazione IRCCS Policlinico San Matteo ( Site 0909)

    Pavia, 27100, Italy

  • Fondazione IRCCS San Gerardo dei Tintori ( Site 0911)

    Monza, Lombardy, 20900, Italy

  • Froedtert Hospital & the Medical College of Wisconsin ( Site 1934)

    Milwaukee, Wisconsin, 53226, United States

  • Fundacion Santa Fe de Bogota ( Site 0302)

    Bogota, Cundinamarca, 110111, Colombia

  • Golden Jubilee National Hospital ( Site 1800)

    Glasgow, West Dunbartonshire, G81 4DY, United Kingdom

  • Gottsegen Gyorgy Orszagos Kardiologiai Intezet ( Site 0702)

    Budapest, 1096, Hungary

  • Guangdong Provincial People s Hospital ( Site 2000)

    Guangzhou, Guangdong, 510080, China

  • Hammersmith Hospital ( Site 1801)

    London, London, City of, W12 OHS, United Kingdom

  • Hospital Britanico de Buenos Aires ( Site 0004)

    CABA, C1280AEB, Argentina

  • Hospital Clinic de Barcelona ( Site 1406)

    Barcelona, Catalonia, 08036, Spain

  • Hospital General Universitario 12 de Octubre ( Site 1403)

    Madrid, 28041, Spain

  • Hospital Marques de Valdecilla ( Site 1405)

    Santander, Cantabria, 39008, Spain

  • Hospital Provincial Jose Maria Cullen ( Site 0005)

    Santa Fe, 3000, Argentina

  • Hospital Ramon y Cajal ( Site 1401)

    Madrid, 28034, Spain

  • Hospital Universitari Son Espases ( Site 1412)

    Palma, Balearic Islands, 07120, Spain

  • Hospital Universitario La Paz ( Site 1410)

    Madrid, 28046, Spain

  • Hospital Universitario de Toledo ( Site 1408)

    Toledo, 45007, Spain

  • Hospital Vall D Hebron ( Site 1404)

    Barcelona, 08035, Spain

  • Hospital Virgen del Rocio ( Site 1407)

    Seville, 41013, Spain

  • IMAT S.A.S ( Site 0301)

    Montería, Departamento de Córdoba, 230002, Colombia

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0905)

    Bologna, Emilia-Romagna, 40138, Italy

  • IUCPQ ( Site 0208)

    Québec, Quebec, G1V 4G5, Canada

  • Indiana University Health Methodist Hospital ( Site 1905)

    Indianapolis, Indiana, 46202, United States

  • Instituto Medico Rio Cuarto ( Site 0010)

    Río Cuarto, Córdoba Province, X5800AEV, Argentina

  • Instituto de Cardiologia Juana F. Cabral ( Site 0008)

    Corrientes, W3400AMZ, Argentina

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006)

    Mar del Plata, Buenos Aires, B7600FZO, Argentina

  • Kaohsiung Veterans General Hospital ( Site 1503)

    Kaohsiung City, 813414, Taiwan

  • Klinikum der Universität München Großhadern ( Site 0611)

    München, Bavaria, 81377, Germany

  • Krakowski Szpital Specjalistyczny im. św. Jana Pawła II ( Site 1100)

    Krakow, Lesser Poland Voivodeship, 31-202, Poland

  • Kyorin University Hospital ( Site 2100)

    Mitaka, Tokyo, 181-8611, Japan

  • Kyushu University Hospital ( Site 2105)

    Fukuoka, 812-8582, Japan

  • Maharaj Nakorn Chiang Mai Hospital ( Site 1601)

    Chiang Mai, 50200, Thailand

  • Medizinische Hochschule Hannover ( Site 0604)

    Hanover, Lower Saxony, 30625, Germany

  • Nagoya University Hospital ( Site 2102)

    Nagoya, Aichi-ken, 466-8560, Japan

  • National Cerebral and Cardiovascular Center ( Site 2103)

    Suita, Osaka, 564-8565, Japan

  • National Cheng Kung University Hospital ( Site 1501)

    Tainan, 70403, Taiwan

  • National Heart Centre Singapore ( Site 1201)

    Singapore, Central Singapore, 169609, Singapore

  • National Hospital Organization Okayama Medical Center ( Site 2104)

    Okayama, 701-1192, Japan

  • National University Heart Centre, Singapore ( Site 1200)

    Singapore, Central Singapore, 119074, Singapore

  • Norton Pulmonary Specialists ( Site 1935)

    Louisville, Kentucky, 40202, United States

  • Ospedale Civile SS Annunziata ( Site 0903)

    Sassari, 07100, Italy

  • Ospedale San Martino ( Site 0901)

    Genoa, Liguria, 16132, Italy

  • Peter Lougheed Centre ( Site 0203)

    Calgary, Alberta, T1Y 6J4, Canada

  • Pulmonary Associates, PA ( Site 1903)

    Phoenix, Arizona, 85032, United States

  • Pusan National University Hospital ( Site 1305)

    Busan, Pusan-Kwangyokshi, 49241, South Korea

  • Pécsi Tudományegyetem Klinikai Központ ( Site 0703)

    Pécs, Pecs, 7624, Hungary

  • Rabin Medical Center ( Site 0805)

    Petah Tikva, 4941492, Israel

  • Radboud University Medical Center ( Site 1001)

    Nijmegen, Gelderland, 6525 GA, Netherlands

  • Rambam Health Care Campus ( Site 0802)

    Haifa, 3109601, Israel

  • Royal Brompton Hospital ( Site 1804)

    London, London, City of, SW3 6NP, United Kingdom

  • Royal Free London NHS Foundation Trust ( Site 1803)

    London, London, City of, NW3 2QG, United Kingdom

  • Royal Papworth Hospital ( Site 1802)

    Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

  • Royal Prince Alfred Hospital ( Site 0103)

    Camperdown, New South Wales, 2050, Australia

  • Samsung Medical Center ( Site 1301)

    Seoul, 06351, South Korea

  • Semmelweis Egyetem ( Site 0701)

    Budapest, Pest County, 1083, Hungary

  • Seoul National University Hospital ( Site 1302)

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System ( Site 1300)

    Seoul, 03722, South Korea

  • Shanghai Pulmonary Hospital ( Site 2004)

    Shanghai, Shanghai Municipality, 200433, China

  • Sheba Medical Center ( Site 0801)

    Ramat Gan, 5265601, Israel

  • Sint Antonius Ziekenhuis ( Site 1000)

    Nieuwegein, Utrecht, 3435CM, Netherlands

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 0704)

    Szeged, Csongrád megye, 6725, Hungary

  • Taipei Veterans General Hospital ( Site 1502)

    Taipei, 11217, Taiwan

  • The Alfred Hospital ( Site 0102)

    Melbourne, Victoria, 3004, Australia

  • The Second Xiangya Hospital of Central South University ( Site 2002)

    Changsha, Hunan, 410011, China

  • The University of Tokyo Hospital ( Site 2101)

    Bunkyo, Tokyo, 113-8655, Japan

  • Thoraxklinik-Heidelberg gGmbH-Zentrum für Pulmonale Hypertonie ( Site 0600)

    Heidelberg, Baden-Wurttemberg, 69126, Germany

  • Universitaetsklinikum Hamburg-Eppendorf ( Site 0610)

    Hamburg, 20246, Germany

  • University of Cincinnati Medical Center ( Site 1927)

    Cincinnati, Ohio, 45219, United States

  • University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 1930)

    Aurora, Colorado, 80045, United States

  • University of Kansas Medical Center ( Site 1928)

    Kansas City, Kansas, 66160, United States

  • University of New Mexico Health Sciences Center - Department of Internal Medicine ( Site 1916)

    Albuquerque, New Mexico, 87131, United States

  • Universitätsklinikum Bonn ( Site 0608)

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Wesley Research Institute ( Site 0101)

    Auchenflower, Queensland, 4066, Australia

  • Westmead Hospital ( Site 0100)

    Westmead, New South Wales, 2145, Australia

  • Yan an Hospital of Kunming City ( Site 2011)

    Kunming, Yunnan, 650051, China

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