Clinical trial NCT06664801: A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024)
Official title: A Phase 2, Multicenter, Single-blinded, Randomized Study to Evaluate the Pharmacokinetics and Safety of Sotatercept (MK-7962) Administered Using Either a Weight-based or Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-10-30
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Researchers are looking for other ways to treat people with PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs.

The goal of the study is to learn:

* What happens to different doses of sotatercept in a person's body over time when it is given using weight-banded doses compared to weight-based doses. There may be differences in how the medicine works with the new dosing method (weight-banded dosing) being studied in this trial.
* About the safety of sotatercept and if people tolerate it


Eligibility criteria: 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

Primary outcomes:
measure: Steady-State Average Serum Concentrations of Sotatercept (Cavg)
timeFrame: Predose and at designated time points post-dose (up to 24 weeks)
measure: Number of Participants Who Experience One or More Adverse Events (AEs)
timeFrame: Up to 37 weeks
measure: Number of Participants who Discontinue Study Treatment due to an Adverse Event
timeFrame: Up to 21 weeks
Secondary outcomes:
measure: Initial Dose Average Serum Concentrations of Sotatercept (Cavg)
timeFrame: Predose and at designated time points post-dose (up to 3 weeks)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pulmonary Associates, PA ( Site 1903)
state: Arizona
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular
state: Colorado
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital ( Site 1905)
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center ( Site 1928)
state: Kansas
city: Louisville
country: United States
facility: Norton Pulmonary Specialists ( Site 1935)
state: Kentucky
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center - Department of Internal Medicine ( Site 1916)
state: New Mexico
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center ( Site 1927)
state: Ohio
city: Austin
country: United States
facility: Ascension Seton Heart Specialty Care and Transplant Center ( Site 1918)
state: Texas
city: Milwaukee
country: United States
facility: Froedtert Hospital & the Medical College of Wisconsin ( Site 1934)
state: Wisconsin
city: La Plata
country: Argentina
facility: Centro Medico Capital ( Site 0002)
state: Buenos Aires
city: Mar del plata
country: Argentina
facility: Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006)
state: Buenos Aires
city: Rio Cuarto
country: Argentina
facility: Instituto Medico Rio Cuarto ( Site 0010)
state: Cordoba
city: Caba
country: Argentina
facility: Hospital Britanico de Buenos Aires ( Site 0004)
city: Corrientes
country: Argentina
facility: Instituto de Cardiologia Juana F. Cabral ( Site 0008)
city: Santa Fe
country: Argentina
facility: Hospital Provincial Jose Maria Cullen ( Site 0005)
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital ( Site 0103)
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital ( Site 0100)
state: New South Wales
city: Auchenflower
country: Australia
facility: Wesley Research Institute ( Site 0101)
state: Queensland
city: Melbourne
country: Australia
facility: The Alfred Hospital ( Site 0102)
state: Victoria
city: Calgary
country: Canada
facility: Peter Lougheed Centre ( Site 0203)
state: Alberta
city: Quebec
country: Canada
facility: IUCPQ ( Site 0208)
city: Guangzhou
country: China
facility: Guangdong Provincial People s Hospital ( Site 2000)
state: Guangdong
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University ( Site 2002)
state: Hunan
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital ( Site 2004)
state: Shanghai
city: Kunming
country: China
facility: Yan an Hospital of Kunming City ( Site 2011)
state: Yunnan
city: Medellín
country: Colombia
facility: Clinica Cardio VID ( Site 0307)
state: Antioquia
city: Monteria
country: Colombia
facility: IMAT S.A.S ( Site 0301)
state: Cordoba
city: Bogota
country: Colombia
facility: Fundacion Santa Fe de Bogota ( Site 0302)
state: Cundinamarca
city: Bogota
country: Colombia
facility: Clinica Colsanitas - Sede Reina Sofia ( Site 0303)
state: Distrito Capital De Bogota
city: Cali
country: Colombia
facility: Centro de Investigaciones Clinicas SAS ( Site 0306)
state: Valle Del Cauca
city: Cali
country: Colombia
facility: Clínica Imbanaco S.A.S ( Site 0304)
state: Valle Del Cauca
city: Prague
country: Czechia
facility: Centrum pro plicní hypertenzi VFN II. interni klinika VFN a 1. LF UK ( Site 0400)
state: Praha 2
city: Pessac
country: France
facility: CHU Bordeaux Haut-Leveque ( Site 0501)
state: Aquitaine
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0500)
state: Bouches-du-Rhone
city: Dijon
country: France
facility: CHU Dijon Bourgogne ( Site 0502)
state: Cote-d Or
city: Rouen
country: France
facility: CHU de Rouen ( Site 0503)
state: Haute-Normandie
city: Clermont-Ferrand
country: France
facility: CHU GABRIEL MONTPIED ( Site 0504)
state: Puy-de-Dome
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH-Zentrum für Pulmonale Hypertonie ( Site 0600)
state: Baden-Wurttemberg
city: Munchen
country: Germany
facility: Klinikum der Universität München Großhadern ( Site 0611)
state: Bayern
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover ( Site 0604)
state: Niedersachsen
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn ( Site 0608)
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0609)
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0610)
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 0704)
state: Csongrad
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem Klinikai Központ ( Site 0703)
state: Pecs
city: Budapest
country: Hungary
facility: Semmelweis Egyetem ( Site 0701)
state: Pest
city: Budapest
country: Hungary
facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet ( Site 0702)
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 0802)
city: Haifa
country: Israel
facility: Carmel Hospital ( Site 0803)
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center ( Site 0805)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 0801)
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0905)
state: Emilia-Romagna
city: Roma
country: Italy
facility: AOU Policlinico Umberto I ( Site 0910)
state: Lazio
city: Genova
country: Italy
facility: Ospedale San Martino ( Site 0901)
state: Liguria
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 0900)
state: Lombardia
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori ( Site 0911)
state: Lombardia
city: Torino
country: Italy
facility: A.O.U. Citta della Salute e della Scienza di Torino ( Site 0904)
state: Piemonte
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata ( Site 0908)
state: Veneto
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0902)
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo ( Site 0909)
city: Pisa
country: Italy
facility: Fondazione G. Monasterio ( Site 0907)
city: Sassari
country: Italy
facility: Ospedale Civile SS Annunziata ( Site 0903)
city: Nagoya
country: Japan
facility: Nagoya University Hospital ( Site 2102)
state: Aichi
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center ( Site 2103)
state: Osaka
city: Bunkyo
country: Japan
facility: The University of Tokyo Hospital ( Site 2101)
state: Tokyo
city: Mitaka
country: Japan
facility: Kyorin University Hospital ( Site 2100)
state: Tokyo
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 2105)
city: Okayama
country: Japan
facility: National Hospital Organization Okayama Medical Center ( Site 2104)
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital (CNUH) ( Site 1304)
state: Kwangju-Kwangyokshi
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital ( Site 1305)
state: Pusan-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 1302)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 1300)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 1303)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 1301)
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center ( Site 1001)
state: Gelderland
city: Nieuwegein
country: Netherlands
facility: Sint Antonius Ziekenhuis ( Site 1000)
state: Utrecht
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. św. Jana Pawła II ( Site 1100)
state: Malopolskie
city: Singapore
country: Singapore
facility: National University Heart Centre, Singapore ( Site 1200)
state: Central Singapore
city: Singapore
country: Singapore
facility: National Heart Centre Singapore ( Site 1201)
state: Central Singapore
city: Palma
country: Spain
facility: Hospital Universitari Son Espases ( Site 1412)
state: Baleares
city: Santander
country: Spain
facility: Hospital Marques de Valdecilla ( Site 1405)
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona ( Site 1406)
state: Cataluna
city: Barcelona
country: Spain
facility: Hospital Vall D Hebron ( Site 1404)
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal ( Site 1401)
city: Madrid
country: Spain
facility: Hospital General Universitario 12 de Octubre ( Site 1403)
city: Madrid
country: Spain
facility: Hospital Universitario La Paz ( Site 1410)
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio ( Site 1407)
city: Toledo
country: Spain
facility: Hospital Universitario de Toledo ( Site 1408)
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital ( Site 1503)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 1501)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 1502)
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital ( Site 1600)
state: Krung Thep Maha Nakhon
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital ( Site 1601)
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital ( Site 1802)
state: Cambridgeshire
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust ( Site 1803)
state: London, City Of
city: London
country: United Kingdom
facility: Royal Brompton Hospital ( Site 1804)
state: London, City Of
city: London
country: United Kingdom
facility: Hammersmith Hospital ( Site 1801)
state: London, City Of
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital ( Site 1800)
state: West Dunbartonshire
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: