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Be Part of Research - Trial Details - A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)

A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)

Completed

Open to: ALL

Age: 18.0 - 75.0

Medical Conditions

Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Hypertension


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus maximum tolerated background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all cause death, lung transplantation, or PAH worsening-related hospitalization of ≥24 hours, in participants with World Health Organization (WHO) functional class (FC) III or FC IV PAH at high risk of mortality.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2021 Jul 2024

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Sotatercept is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.

Intervention Arm Group : Sotatercept plus background PAH therapy;

Intervention Type : OTHER
Intervention Description : Placebo

Intervention Arm Group : Placebo plus background PAH therapy;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Papworth Hospital ( Site 1208)
    Cambridge
    Cambridgeshire
    CB23 3RE
  • Royal Brompton Hospital ( Site 1206)
    London
    London, City Of
    SW3 6JY
  • Imperial College Healthcare NHS Trust ( Site 1203)
    London
    London, City Of
    W2 1NY


The study is sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA




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Read full details for Trial ID: NCT04896008
Last updated 18 March 2025

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