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NCT05587712 · ClinicalTrials.gov registry record · Phase 2

Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)

A Phase 2 study of Pulmonary Arterial Hypertension, sponsored by Merck Sharp & Dohme.

Recruiting
Registry status
Phase 2
Development phase
42
Enrollment target
20
Study locations

NCT05587712: Recruiting Phase 2 study of Pulmonary Arterial Hypertension, sponsored by Merck Sharp & Dohme.

NCT05587712 is a Phase 2 study of Pulmonary Arterial Hypertension that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 42 participants, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05587712, a Phase 2 study of Pulmonary Arterial Hypertension, is actively recruiting participants, sponsored by Merck Sharp & Dohme.

RECRUITING
Registry status
Phase 2
Development phase
42 participants
Enrollment target
20
Study locations

Study Summary

The primary objectives of the study are to evaluate the safety and tolerability, and pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to \<18 years of age with PAH World Health Organization (WHO) Group 1 on standard of care (SoC). There is no formal hypothesis.

Primary Outcome

Ctrough was the lowest concentration of Sotatercept in serum just before the next dose. Blood samples will be collected at multiple time points to estimate the Ctrough of Sotatercept.

Conditions Studied

Pulmonary Arterial Hypertension

Interventions

  • DRUG Sotatercept

Study Locations (20)

California

  • The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 1606) - Los Angeles
  • Stanford University School of Medicine ( Site 1603) - Palo Alto
  • UCSF Benioff Children's Hospital San Francisco ( Site 1611) - San Francisco

Valle del Cauca Department

  • Fundación Valle del Lili ( Site 0200) - Cali
  • Clínica Imbanaco S.A.S ( Site 0203) - Cali

Colorado

  • Children's Hospital Colorado ( Site 1609) - Aurora

District of Columbia

  • Children's National Medical Center ( Site 1600) - Washington D.C.

Ohio

  • Cincinnati Children's Hospital Medical Center ( Site 1602) - Cincinnati

Pennsylvania

  • Children's Hospital of Philadelphia (CHOP) ( Site 1608) - Philadelphia

Tennessee

  • Monroe Carell Jr. Children's Hospital ( Site 1601) - Nashville

Washington

  • Seattle Children's Hospital ( Site 1605) - Seattle

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2023-01-19
Est. Completion 2028-09-21
Phase Phase 2
Merck Sharp & Dohme

558 total trials

What NCT05587712 shows while recruiting

NCT05587712 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (91% lower).

The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 1 intervention - of which Sotatercept is the first listed.

NCT05587712 names 20 study sites across 17 states, led by California, Valle del Cauca Department, Colorado.

Frequently Asked Questions

What is clinical trial NCT05587712 about?

NCT05587712 is a clinical study titled "Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)". The primary objectives of the study are to evaluate the safety and tolerability, and pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to \<18 years of age with PAH World Health Organization (WHO) Group 1 on standard of care (SoC). There is no formal hypothesis.

What is the current status of trial NCT05587712?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2023-01-19. Estimated completion is 2028-09-21.

What conditions does trial NCT05587712 study?

This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.

What interventions are being tested in trial NCT05587712?

The interventions under investigation include: Sotatercept (DRUG).

Who is sponsoring clinical trial NCT05587712?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05587712 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Pulmonary Arterial Hypertension

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05587712's enrollment target sits among peer trials

42 34th of 63 higher than 30 of 63 other Pulmonary Arterial Hypertension trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pulmonary Arterial Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05587712

Source: ClinicalTrials.gov NCT05587712, the US trial registry maintained by the National Library of Medicine. NCT05587712 (small enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.