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Testing a new dosing method for sotatercept in patients with pulmonary arterial hypertension

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

PHASE2 · Merck Sharp & Dohme LLC · NCT06664801

This study is testing a new way to dose the medication sotatercept for people with pulmonary arterial hypertension to see if it works better and is safe compared to the usual method.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment160 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC (industry)
Locations98 sites (Phoenix, Arizona and 97 other locations)
Trial IDNCT06664801 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of sotatercept, a medication for pulmonary arterial hypertension (PAH), using a new weight-banded dosing method compared to traditional weight-based dosing. The study aims to assess how different doses of the drug are processed in the body over time and to evaluate the safety and tolerability of sotatercept in participants. Patients with symptomatic PAH classified as WHO Functional Class II or III will be enrolled, and their responses to the treatment will be closely monitored.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with World Health Organization (WHO) Group 1 pulmonary arterial hypertension who are symptomatic and classified as WHO Functional Class II or III.

Not a fit: Patients with pulmonary hypertension classified under WHO Groups 2, 3, 4, or 5, or those with specific contraindications, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective dosing strategy for treating pulmonary arterial hypertension, potentially improving patient outcomes.

How similar studies have performed: While this approach is novel in the context of sotatercept, similar studies have shown promise in optimizing dosing strategies for other PAH treatments.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Has documented diagnostic Right Heart Catheterization, with the diagnosis of World Health Organization (WHO) Pulmonary Atrial Hypertension (PAH) Group 1 in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAH associated with connective tissue disease, PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
* Has symptomatic PAH classified as WHO Functional Class II or III

Exclusion Criteria:

* Has a weight of \<35 kg
* Has a diagnosis of PH WHO Groups 2, 3, 4, or 5
* Has a diagnosis of the following PAH Group 1 subtypes: HIV-associated PAH, PAH associated with portal hypertension, Exclusion in PAH Group 1 should also include schistosomiasis-associated PAH, pulmonary veno occlusive disease and pulmonary capillary hemangiomatosis
* Has uncontrolled systemic hypertension
* Has a history of pneumonectomy
* Has a history of known pericardial constriction
* Has a history of restrictive cardiomyopathy
* Has history of atrial septostomy (within 180 days prior to study start)
* Has personal or family history of long QT syndrome
* Has history of coronary artery disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass, graft surgery, or cardiac anginal chest pain) (within 6 months prior to study start)
* Has a cerebrovascular accident (within 3 months prior to study start)
* Has significant (\>2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
* Has untreated more than mild obstructive sleep apnea
* Has known malignancy that is progressing or has required active treatment within the past 5 years
* Has recently started (within 12 months prior to study start) or has plans to start weight loss medication or enter a weight loss program during the study period
* Has a previous (within 3 years) or planned (during the study) obesity treatment with surgery or a weight-loss device

Where this trial is running

Phoenix, Arizona and 97 other locations

+48 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Pulmonary Arterial Hypertension

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.