Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
212
Countries
7
Sites
28
Pulmonary Arterial Hypertension (PAH)
1. To evaluate the long-term safety and tolerability of sotatercept using weight-banded dosing
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 19 Jun 2025 → ongoing
- Decision date (initial)
- 2025-05-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2024-518687-12-00
- WHO UTN
- U1111-1314-0614
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Safety, Diagnosis, Therapy, Pharmacodynamic
1. To evaluate the long-term safety and tolerability of sotatercept using weight-banded dosing
Conditions and MedDRA coding
Pulmonary Arterial Hypertension (PAH)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10064911 | Pulmonary arterial hypertension | 100000004855 |
Regulatory references
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-512278-92-00 | 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 | Merck Sharp & Dohme LLC |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Has completed the treatment period of study MK-7962-024 (LIGHTRAY) (including Visit 11) on study intervention, did not discontinue study intervention, and is able to safely enroll into MK-7962-031 (LIGHTRAY EXTENSION)
- Has not started treatment with commercially available sotatercept
Exclusion criteria 1
- Has prior exposure to luspatercept and/or is planning to begin treatment with luspatercept while enrolled in the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Number of participants with one or more adverse events (AEs)
- Number of participants who discontinue study intervention due to an AE
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
SUB189200 · Substance
- Active substance
- Sotatercept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 90 mg milligram(s)
- Max total dose
- 5200 mg milligram(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/20/2369
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Manufacturers, container closure system for pediatric use (syringe and needle), and shelf-life.
PRD9659365 · Product
- Active substance
- Sotatercept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 90 mg milligram(s)
- Max total dose
- 5200 mg milligram(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/20/2369
PRD9659366 · Product
- Active substance
- Sotatercept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 90 mg milligram(s)
- Max total dose
- 5200 mg milligram(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/20/2369
SUB189200 · Substance
- Active substance
- Sotatercept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 90 mg milligram(s)
- Max total dose
- 5200 mg milligram(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/20/2369
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Manufacturers, container closure system for pediatric use (syringe and needle), and shelf-life.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Michela Brambatti
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Michela Brambatti
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| Imperial Clinical Research Services International Ltd. ORG-100050069
|
Grand Rapids, United States | Other |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| PPD International Holdings LLC ORG-100007655
|
Zaventem, Belgium | Laboratory analysis |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Interactive response technologies (IRT) |
Locations
7 EU/EEA countries · 28 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruitment ended | 2 | 1 |
| France | Ongoing, recruitment ended | 10 | 4 |
| Hungary | Ongoing, recruitment ended | 8 | 3 |
| Italy | Ongoing, recruitment ended | 22 | 9 |
| Netherlands | Ongoing, recruitment ended | 4 | 2 |
| Poland | Ongoing, recruitment ended | 3 | 1 |
| Spain | Ongoing, recruitment ended | 18 | 8 |
| Rest of world
Taiwan, Israel, Canada, Australia, Korea, Republic of, Argentina, Colombia, Turkey, Thailand, Singapore, United States, China, United Kingdom, Japan
|
— | 145 | — |
Investigational sites
Vseobecna Fakultni Nemocnice V Praze
II. interní klinika kardiologie a angiologie VFN a 1.LF UK, U Nemocnice 499/2, Nove Mesto, Prague
Centre Hospitalier Universitaire Rouen
Service de Pneumologie, Oncologie Thoracique et Soins Intensifs Respiratoires, 1 Rue De Germont, Bp 96031, Rouen Cedex
CHU Gabriel-Montpied
Cardiologie médicale et médecine vasculaire, 58 Rue Montalembert, 63000, Clermont Ferrand
Centre Hospitalier Universitaire De Bordeaux
Service de Cardiologie, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Regional De Marseille
Service de Pneumologie, 265 Chemin Des Bourrely, 13015, Marseille
University Of Szeged
Szent-Györgyi Albert Klinikai Központ, Családorvosi Intézet és Rendelő, Tisza Lajos Korut 109, 6725, Szeged
Clinic Of Pulmonology Semmelweis University
Pulmonológiai Klinika, Tomo Utca 25-29, 1083, Budapest Viii
Gottsegen National Cardiovascular Center
Felnőtt Kardiológiai Osztály, Kerulet, Haller Utca 29/IX., Budapest
Fondazione IRCCS San Gerardo Dei Tintori
U.O.C. Pneumologia, Via Giovanni Battista Pergolesi 33, 20900, Monza
Azienda Ospedaliero-Universitaria Policlinico Umberto I
UOC Malattie Cardiovascolari, Viale Del Policlinico 155, 00161, Rome
IRCCS Ospedale Policlinico San Martino
DICATOV Dipartimento CardioToracoVascolare, Largo Rosanna Benzi 10, 16132, Genoa
Fondazione IRCCS Policlinico San Matteo
S.C. Cardiologia, Viale Camillo Golgi 19, 27100, Pavia
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Dipartimento cardio-toraco-vascolare, Via Francesco Sforza 28, 20122, Milan
ASST Grande Ospedale Metropolitano Niguarda
Dipartimento Cardiotoracovascolare, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
U.O.C. Cardiologia, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Universitaria Integrata Verona
U.O.C. Cardiologia, Piazzale Aristide Stefani 1, 37126, Verona
Azienda Ospedaliero Universitaria Di Sassari
Sc Cardiologia Clinica e Interventistica, Viale San Pietro 10, 07100, Sassari
Radboud universitair medisch centrum Stichting
Cardiology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Sint Antonius Ziekenhuis Stichting
Cardiology, Koekoekslaan 1, 3435 CM, Nieuwegein
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Ul. Pradnicka 80, 31-202, Cracow
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Neumology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinic De Barcelona
Neumology, Calle Villarroel 170, 08036, Barcelona
University Hospital Virgen Del Rocio S.L.
Neumology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario La Paz
Neumology, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario De Toledo
Neumology, Avenue Del Rio Guadiana Sn, 45007, Toledo
Hospital Universitario 12 De Octubre
Neumology, Avenida De Cordoba Sn, 28041, Madrid
University Hospital Son Espases
Neumology, Carretera Valldemossa 79, 07120, Palma
Hospital Universitario Marques De Valdecilla
Neumology, Avenida Valdecilla Sn, 39008, Santander
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2025-08-26 | 2025-08-28 | 2025-11-20 | ||
| France | 2025-07-02 | 2025-07-24 | 2025-09-02 | ||
| Hungary | 2025-08-21 | 2025-09-04 | 2025-09-16 | ||
| Italy | 2025-07-17 | 2025-07-21 | 2025-09-29 | ||
| Netherlands | 2025-06-24 | 2025-06-25 | 2025-09-17 | ||
| Poland | 2025-10-09 | 2025-10-10 | 2025-10-10 | ||
| Spain | 2025-06-19 | 2025-06-20 | 2025-11-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 38 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-518687-12_SM02_for pub | 01R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_CZE_CS_IN_for pub | 22JAN2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ESP_ES_IN_for pub | 17DEC2024R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FRA_FR_SM01_for pub | 03JUN2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_HUN_EN_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ITA_EN_IN_for pub | 07JAN2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_NLD_EN_NSM01_for pub | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_POL_PL_IN_for pub | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_FRA_FR_SM01_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_FRA_FR_SM02_for pub | 0.02 |
| Subject information and informed consent form (for publication) | L1_ICF_Main adult consent_ESP_ES_IN-RFI015_for pub | 01R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_CZE_CS_IN-RFI014_for pub | 2R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FRA_FR_SM02_for pub | 0.02R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_HUN_HU_IN-RFI017_for pub | 0.01R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ITA_IT_IN-RFI011_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_NLD_EN_NSM02_for pub | 0.01R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_POL_PL_IN-RFI016_for pub | 01R |
| Subject information and informed consent form (for publication) | L1_ICF_Main data privacy_ITA_IT_IN_for pub | 07JAN2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Main GDPR_CZE_CS_IN_for pub | Czech v3 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_DILI sample_ITA_IT_IN_for pub | 07JAN2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_CZE_CS_IN_for pub | Czech v1 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_ESP_ES_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_NLD_NL_SM02_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_ESP_ES_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_HUN_HU_IN-RFI005_for pub | 0.00R |
| Subject information and informed consent form (for publication) | L2_Patient emergency card_HUN_HU_IN_for pub | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient ID Card_CZE_CS_IN_for pub | 1.0 00 1.2 |
| Subject information and informed consent form (for publication) | L2_Patient instructions_CZE_EN_IN_for pub | 22JAN2025 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-518687-12_CZE_CS_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-518687-12_ESP_ES_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-518687-12_FRA_FR_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-518687-12_HUN_HU_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-518687-12_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-518687-12_ITA_IT_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-518687-12_NLD_NL_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-518687-12_POL_PL_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2024-518687-12_HUN_HU_IN_for pub | 0.00 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2024-518687-12-00_CZE_CS_IN_for pub | CZE v1 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-30 | Netherlands | Acceptable with conditions 2025-05-26
|
2025-05-26 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-03 | Netherlands | Acceptable with conditions 2025-05-26
|
2025-06-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-05 | Acceptable with conditions | 2025-06-30 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-22 | Netherlands | Acceptable 2025-09-08
|
2025-09-08 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-16 | Netherlands | Acceptable 2025-09-08
|
2025-09-16 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-09-18 | Netherlands | Acceptable 2025-09-08
|
2025-09-18 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-12-18 | Acceptable 2025-09-08
|
2025-12-18 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-07 | Acceptable | 2026-01-23 |