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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06925750




Registration number
NCT06925750
Ethics application status
Date submitted
7/04/2025
Date registered
13/04/2025
Date last updated
10/09/2025

Titles & IDs
Public title
A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-031/LIGHTRAY EXTENSION)
Scientific title
An Open-label Extension Study to Evaluate Safety and Tolerability of Sotatercept (MK-7962) Administered Using a Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care
Secondary ID [1] 0 0
MK-7962-031
Secondary ID [2] 0 0
7962-031
Universal Trial Number (UTN)
Trial acronym
LIGHTRAY EXT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Sotatercept
Treatment: Drugs - Background PAH Therapy

Experimental: Weight-banded sotatercept dosing - Participants will receive sotatercept via subcutaneous (SC) injection every 3 weeks at an initial dose of up to 45 mg and then at a maintenance dose of up to 90 mg using a weight-banded method and will continue treatment for up to 24 months. All eligible participants will receive weight-banded dosing at the dosing level (initial or maintenance) at which they finished MK-7962-024 (LIGHTRAY). Participants will continue to take their background PAH therapy during the study.


Treatment: Other: Sotatercept
SC injection administered every 3 weeks

Treatment: Drugs: Background PAH Therapy
Background PAH therapy may consist of the following drug classes: single, double, or triple combination of therapy with endothelin-receptor antagonists, phosphodiesterase inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogs or receptor antagonists
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Experience One or More Adverse Events (AEs)
Timepoint [1] 0 0
Up to approximately 28 months
Primary outcome [2] 0 0
Number of Participants who Discontinue Study Intervention Due to an AE
Timepoint [2] 0 0
Up to approximately 24 months

Eligibility
Key inclusion criteria
The main inclusion criteria include but are not limited to the following:

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The main exclusion criteria include but are not limited to the following:

- Has current exposure or is planning to begin treatment with an activin signaling inhibitor (other than sotatercept)

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/05/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2027
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Westmead Hospital ( Site 0100) - Westmead
Recruitment hospital [2] 0 0
Wesley Research Institute ( Site 0101) - Auchenflower
Recruitment hospital [3] 0 0
The Alfred Hospital ( Site 0102) - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
New Mexico
Country [4] 0 0
Argentina
State/province [4] 0 0
Buenos Aires
Country [5] 0 0
Argentina
State/province [5] 0 0
Córdoba Province
Country [6] 0 0
Argentina
State/province [6] 0 0
Corrientes
Country [7] 0 0
Argentina
State/province [7] 0 0
Santa Fe
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
China
State/province [9] 0 0
Guangdong
Country [10] 0 0
China
State/province [10] 0 0
Hunan
Country [11] 0 0
China
State/province [11] 0 0
Shanghai Municipality
Country [12] 0 0
China
State/province [12] 0 0
Yunnan
Country [13] 0 0
Colombia
State/province [13] 0 0
Bogota D.C.
Country [14] 0 0
Colombia
State/province [14] 0 0
Departamento de Córdoba
Country [15] 0 0
Colombia
State/province [15] 0 0
Valle del Cauca Department
Country [16] 0 0
Czechia
State/province [16] 0 0
Praha 2
Country [17] 0 0
France
State/province [17] 0 0
Aquitaine
Country [18] 0 0
France
State/province [18] 0 0
Bouches-du-Rhone
Country [19] 0 0
France
State/province [19] 0 0
Haute-Normandie
Country [20] 0 0
France
State/province [20] 0 0
Puy-de-Dome
Country [21] 0 0
Hungary
State/province [21] 0 0
Csongrád megye
Country [22] 0 0
Hungary
State/province [22] 0 0
Pest County
Country [23] 0 0
Israel
State/province [23] 0 0
Haifa
Country [24] 0 0
Israel
State/province [24] 0 0
Petah Tikva
Country [25] 0 0
Israel
State/province [25] 0 0
Ramat Gan
Country [26] 0 0
Italy
State/province [26] 0 0
Lombardy
Country [27] 0 0
Italy
State/province [27] 0 0
Veneto
Country [28] 0 0
Italy
State/province [28] 0 0
Bologna
Country [29] 0 0
Italy
State/province [29] 0 0
Genova
Country [30] 0 0
Italy
State/province [30] 0 0
Pavia
Country [31] 0 0
Italy
State/province [31] 0 0
Roma
Country [32] 0 0
Italy
State/province [32] 0 0
Sassari
Country [33] 0 0
Japan
State/province [33] 0 0
Aichi-ken
Country [34] 0 0
Japan
State/province [34] 0 0
Osaka
Country [35] 0 0
Japan
State/province [35] 0 0
Tokyo
Country [36] 0 0
Japan
State/province [36] 0 0
Fukuoka
Country [37] 0 0
Japan
State/province [37] 0 0
Okayama
Country [38] 0 0
Netherlands
State/province [38] 0 0
Gelderland
Country [39] 0 0
Netherlands
State/province [39] 0 0
Utrecht
Country [40] 0 0
Singapore
State/province [40] 0 0
Central Singapore
Country [41] 0 0
South Korea
State/province [41] 0 0
Kwangju-Kwangyokshi
Country [42] 0 0
South Korea
State/province [42] 0 0
Pusan-Kwangyokshi
Country [43] 0 0
South Korea
State/province [43] 0 0
Seoul
Country [44] 0 0
Spain
State/province [44] 0 0
Balearic Islands
Country [45] 0 0
Spain
State/province [45] 0 0
Cantabria
Country [46] 0 0
Spain
State/province [46] 0 0
Catalonia
Country [47] 0 0
Spain
State/province [47] 0 0
Barcelona
Country [48] 0 0
Spain
State/province [48] 0 0
Madrid
Country [49] 0 0
Spain
State/province [49] 0 0
Seville
Country [50] 0 0
Spain
State/province [50] 0 0
Toledo
Country [51] 0 0
Taiwan
State/province [51] 0 0
Tainan City
Country [52] 0 0
Taiwan
State/province [52] 0 0
Taipei
Country [53] 0 0
Thailand
State/province [53] 0 0
Bangkok
Country [54] 0 0
Thailand
State/province [54] 0 0
Chiang Mai
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Cambridgeshire
Country [56] 0 0
United Kingdom
State/province [56] 0 0
England
Country [57] 0 0
United Kingdom
State/province [57] 0 0
London, City of
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Scotland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://externaldatasharing-msd.com/


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06925750