Sotatercept for Pulmonary Arterial Hypertension

(SOTERIA Trial)

Recruiting at 5 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Pregnancy, Breastfeeding, Incapacitated, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 3 years

815 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on the long-term safety and tolerability of sotatercept for treating pulmonary arterial hypertension (PAH). PAH leads to high blood pressure in the lungs as blood vessels thicken and narrow, making breathing and activity difficult. Sotatercept targets specific proteins involved in PAH. This trial is open to individuals who completed a previous study with sotatercept and are willing to adhere to the study schedule. As a Phase 3 trial, it represents the final step before FDA approval, giving participants the opportunity to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it mentions that sotatercept is taken with standard PAH treatment, so you may be able to continue your usual PAH medications.

Is there any evidence suggesting that sotatercept is likely to be safe for humans?

Research has shown that sotatercept may be a promising treatment for pulmonary arterial hypertension (PAH) and is generally safe. In studies, patients taking sotatercept experienced fewer serious issues, such as death or hospitalization, compared to those on a placebo. The treatment reduced the risk of death by 85%. Most side effects were mild, with some patients experiencing higher levels of hemoglobin, a measure of red blood cells. Overall, sotatercept has been well-tolerated, making it a hopeful option for managing PAH. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PAH?

Sotatercept is unique because it offers a new approach to treating pulmonary arterial hypertension (PAH) by targeting the transforming growth factor-beta (TGF-beta) superfamily, which plays a role in blood vessel health. Unlike standard treatments for PAH, such as endothelin receptor antagonists and phosphodiesterase-5 inhibitors, which primarily focus on dilating blood vessels, sotatercept works by addressing the underlying causes of blood vessel remodeling and stiffness. This novel mechanism of action has the potential to not only alleviate symptoms but also modify the disease course, making it an exciting prospect for researchers and patients alike.

What evidence suggests that sotatercept might be an effective treatment for PAH?

Studies have shown that sotatercept can help people with pulmonary arterial hypertension (PAH), a condition where blood vessels in the lungs thicken and narrow, making breathing difficult. In one study, patients experienced improvements within the first 24 weeks, and these benefits lasted up to two years with ongoing treatment. Sotatercept targets specific proteins involved in PAH, improving blood flow in the lungs. Another study found that sotatercept improved health outcomes when administered soon after a PAH diagnosis. While some side effects, such as increased hemoglobin levels, were noted, they were generally rare. Overall, sotatercept shows promise in improving the lives of people with PAH. ^{5 6 7 8}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for people who have Pulmonary Arterial Hypertension (PAH) and previously participated in the MK-7962-004 study. Participants should be willing to follow the study schedule and comply with all requirements.

Inclusion Criteria

I have completed the MK-7962-004 study requirements.

I am willing and able to follow the study's schedule and rules.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants continue sotatercept at their current dose, with potential titration up to 0.7 mg/kg SC injection

Up to approximately 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 3 years

Open-label extension

Participants may continue to receive sotatercept to evaluate long-term safety and tolerability

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Sotatercept

Trial Overview The trial is testing Sotatercept, a targeted therapy designed to treat PAH by working on specific proteins involved in the disease. The focus is on its long-term safety and tolerability when used alongside standard PAH treatments.

How Is the Trial Designed?

Group I: Sotatercept Experimental Treatment 1 Intervention

Participants enrolling from the MK-7962-004 sotatercept study will continue sotatercept at their current dose. If currently at a dose \<0.7 mg/kg subcutaneous (SC) injection, participants can titrate up to 0.7 mg/kg SC injection for the remainder of this study.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39978862/

A long-term follow-up study of sotatercept for treatment ... Interim results of SOTERIA support the favourable benefit-risk of add-on sotatercept treatment in adults with PAH. Follow-up reports from ...

2. jwatch.org jwatch.org/na59304/2025/10/09/sotatercept-beneficial-recent-onset-pulmonary-arterial

Sotatercept Beneficial in Recent-Onset Pulmonary Arterial ... The activin-signaling inhibitor improved clinical outcomes in patients when given within 1 year of PAH diagnosis. ... PAH based on trials in those ...

3. atsjournals.org atsjournals.org/doi/abs/10.1164/ajrccm.2025.211.Abstracts.A7602

Early Outcomes of Sotatercept in Pulmonary Arterial ... Mean RVFWS improved to -19% [-21% to -14.6%] (p = 0.032). Side effects were infrequent, except for an increment in Hb levels by a mean 1.92±1.4 g/dL (p<0.0001).

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2213558

Phase 3 Trial of Sotatercept for Treatment of Pulmonary ... Improvements were observed within the first 24 weeks of treatment and maintained over a period of 18 to 24 months with continued sotatercept therapy. In the ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40602626/

Clinical outcomes and safety of sotatercept in pulmonary ... Conclusion: Sotatercept significantly improves functional and hemodynamic outcomes in PAH, with a favorable safety profile. While mortality benefits remain ...

6. nejm.org nejm.org/doi/pdf/10.1056/NEJMoa2508170

Sotatercept for Pulmonary Arterial Hypertension within the ... Safety data were analyzed descriptively; differences in percentages and 95% confidence intervals were calculated with the method of Miettinen ...

7. ajmc.com ajmc.com/view/sotatercept-for-pah-maintains-safety-reduced-mortality-in-long-term-follow-up

Sotatercept for PAH Maintains Safety, Reduced Mortality in ... Sotatercept significantly reduced mortality risk by 85% in patients with PAH compared with placebo. The safety profile of sotatercept remained ...

8. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2025/03/28/02/58/zenith

Sotatercept In High-Risk Patients With Pulmonary Arterial ... Treatment with sotatercept resulted in a lower risk of all-cause death, lung transplantation, and hospitalization (≥24 hours) for worsening PAH than placebo.