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Clinical Trials List

Protocol NumberMK-7962-031

NCT Number(ClinicalTrials.gov Identfier)NCT06925750

Active

2025-03-01 - 2032-12-31

Phase II

Recruiting3

ICD-10I27.0

Primary pulmonary hypertension

ICD-9416.0

Primary pulmonary hypertension

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

Trial Applicant

Merck Sharp & Dohme (I.A.) LLC
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator 林坤璋 Division of General Internal Medicine

Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shih-Hsien Sung 無

Taipei Veterans General Hospital

Co-Principal Investigator

黃偉銘無
Kang-Ling Wang 醫學研究部

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Hsin Hsu

National Taiwan University Hospital

Co-Principal Investigator

林佳淩 Division of Cardiovascular Diseases
林佳凌無

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Pulmonary Arterial Hypertension

Objectives

Primary objective: To evaluate the long-term safety and tolerability of sotatercept administered via a weight-segmented dosing method. Exploratory objective: To evaluate the long-term effect of sotatercept on the concentration of N-terminal pro-B-type natriuretic peptide (NT-proBNP) using a weight-segmented dosing method.

Test Drug

凍晶乾燥注射劑

Active Ingredient

Sotatercept

Dosage Form

245

Dosage

45 mg/vial

Endpoints

Adverse events (AEs) and discontinuation of trial treatment due to AEs

Inclution Criteria

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

Exclusion Criteria

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)

The Estimated Number of Participants

Taiwan

9 participants
Global

130 participants