Sotatercept for Pulmonary Arterial Hypertension

(HYPERION Trial)

Recruiting at 210 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Acceleron Pharma Inc.

Must be taking: PAH therapies

Must not be taking: Intravenous inotropes

Disqualifiers: Hypertension, HIV, Hepatitis, others

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 36 months

321 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing sotatercept, a new medication, to see if it can help people with a specific type of high blood pressure in the lungs (PAH) when added to their usual treatment. The study focuses on patients who are newly diagnosed and at higher risk of their condition worsening. Sotatercept aims to reduce the pressure in the lung's blood vessels, potentially slowing down disease progression. Sotatercept has shown significant reduction in pulmonary vascular resistance and maintained clinical efficacy in previous studies.

Do I need to stop my current medications to join the trial?

The trial does not specify that you need to stop your current medications. In fact, participants must be on stable doses of a double or triple combination of background PAH therapies and diuretics for at least 90 days prior to screening. However, you should discuss your specific medications with the trial team to ensure they are compatible with the study requirements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on stable doses of your current PAH therapies and diuretics for at least 90 days before joining the study.

What safety data is available for sotatercept in treating pulmonary arterial hypertension?

The safety data for sotatercept in treating pulmonary arterial hypertension has been evaluated in several studies. The PULSAR open-label extension study reported cumulative safety data for sotatercept over 18-24 months, indicating a significant reduction in pulmonary vascular resistance compared to placebo. The STELLAR trial also assessed sotatercept's safety and efficacy, showing improvements in 6-minute walk distance when added to stable background therapy. These studies suggest that sotatercept has been investigated for both short-term and longer-term safety in clinical trials. ^{1 2 3 4 5}

Is sotatercept safe for humans?

Sotatercept has been studied in people with pulmonary arterial hypertension, and longer-term safety data from the PULSAR trial suggests it is generally safe for use in humans. ^{1 2 3 4 5}

Is the drug Sotatercept a promising treatment for Pulmonary Arterial Hypertension?

Yes, Sotatercept is a promising drug for Pulmonary Arterial Hypertension. It has been shown to improve walking distance and reduce resistance in blood vessels, which are important for patients with this condition. It also aims to balance growth signals in the body, potentially improving long-term health outcomes. ^{1 2 3 4 6}

What makes the drug sotatercept unique for treating pulmonary arterial hypertension?

Sotatercept is unique because it is a fusion protein that targets and traps activins and growth differentiation factors, which are involved in the disease process of pulmonary arterial hypertension. This mechanism aims to restore balance between growth-promoting and growth-inhibiting signals, offering a novel approach compared to existing treatments. ^{1 2 3 4 6}

What data supports the idea that Sotatercept for Pulmonary Arterial Hypertension is an effective drug?

The available research shows that Sotatercept is effective for treating Pulmonary Arterial Hypertension. In one study, adding Sotatercept to existing treatments helped patients walk farther in six minutes after 24 weeks. Another study found that Sotatercept significantly reduced the resistance in blood vessels in the lungs compared to a placebo. These improvements suggest that Sotatercept can help manage the condition better than some other treatments. ^{1 2 3 6 7}

What data supports the effectiveness of the drug sotatercept for pulmonary arterial hypertension?

Research shows that adding sotatercept to existing treatments for pulmonary arterial hypertension (a type of high blood pressure affecting the lungs) improved patients' ability to walk further in 6 minutes after 24 weeks. Additionally, sotatercept significantly reduced the resistance in blood vessels in the lungs compared to a placebo, showing its potential to help manage this condition. ^{1 2 3 6 7}

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 adults over 18 with newly diagnosed Pulmonary Arterial Hypertension (PAH) who are at intermediate or high risk of disease progression. They must be able to walk a certain distance and adhere to the study's schedule. Women of childbearing age and men must follow strict contraception guidelines.

Inclusion Criteria

You have a higher risk of complications related to pulmonary hypertension based on certain scoring systems.

Ability to adhere to study visit schedule and understand and comply with all protocol requirements

I have had a heart cath test showing specific heart and lung pressures, indicating a certain type of high blood pressure in my lung arteries.

Exclusion Criteria

Pregnant or breastfeeding women

Your heart's electrical activity shows a specific pattern that may not be safe for the study.

I have a history of certain medical conditions or surgeries.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sotatercept or placebo plus background PAH therapy administered subcutaneously every 21 days

Up to 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term in the MK-7962-004 extension study or by commercial access

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Sotatercept

Trial Overview The trial tests if Sotatercept, on top of standard PAH therapy, can delay the worsening of PAH symptoms compared to a placebo. Participants will either receive Sotatercept or a placebo alongside their regular treatment for PAH.

How Is the Trial Designed?

Group I: Sotatercept plus background PAH therapy Experimental Treatment 1 Intervention

Administered at a starting dose of 0.3 mg/kg, with a target dose of 0.7 mg/kg, subcutaneously (SC) every 21 days plus background PAH therapy

Group II: Placebo plus background PAH therapy Placebo Group 1 Intervention

Administered subcutaneously (SC) every 21 days plus background PAH therapy

Who Is Running the Clinical Trial?

Acceleron Pharma Inc.

Lead Sponsor

Trials

27

Recruited

3,100+

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

Lead Sponsor

Trials

33

Recruited

4,300+

Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

Lead Sponsor

Trials

33

Recruited

4,300+

Published Research Related to This Trial

In a study involving 106 participants with pulmonary arterial hypertension, sotatercept demonstrated significant long-term efficacy in reducing pulmonary vascular resistance and improving functional outcomes over 24 months, with sustained benefits observed in both groups receiving sotatercept.

The treatment was generally safe, with serious adverse events occurring in 30.8% of participants, but only a small number (2.9%) of deaths were reported, none linked to the drug, indicating a favorable safety profile for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sotatercept for the treatment of pulmonary arterial hypertension: PULSAR open-label extension. Humbert, M., McLaughlin, V., Gibbs, JSR., et al.[2023]

In a 24-week trial involving 106 adults with pulmonary arterial hypertension, sotatercept significantly reduced pulmonary vascular resistance compared to placebo, indicating its efficacy in improving this condition.

Sotatercept also improved exercise capacity, as shown by a greater increase in 6-minute walk distance in the treatment groups, although some hematologic adverse events were noted, including thrombocytopenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sotatercept for the Treatment of Pulmonary Arterial Hypertension. Humbert, M., McLaughlin, V., Gibbs, JSR., et al.[2021]

In the phase 3 STELLAR trial, sotatercept significantly improved key hemodynamic parameters in patients with pulmonary arterial hypertension (PAH), including a reduction in mean pulmonary artery pressure by 13.9 mmHg and pulmonary vascular resistance by 254.8 dyn·s·cm-5, indicating enhanced right heart function.

Sotatercept also showed improvements in right ventricular work and power, as well as echocardiographic measures of right heart function, suggesting it may be an effective treatment option for managing PAH in pre-treated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of sotatercept on haemodynamics and right heart function: analysis of the STELLAR trial. Souza, R., Badesch, DB., Ghofrani, HA., et al.[2023]

The Phase 3 STELLAR trial demonstrated that sotatercept significantly improves exercise capacity and reduces pulmonary vascular resistance in patients with pulmonary arterial hypertension, indicating its efficacy as a treatment option.

The study involved a large cohort of patients, providing robust evidence for the safety and effectiveness of sotatercept in managing this serious condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In symptomatic PAH, adding sotatercept to stable background therapy improved 6-min walk distance at 24 wk. Estrada, RA.[2023]

In a phase 3 trial involving 323 adults with pulmonary arterial hypertension, sotatercept significantly improved exercise capacity, as measured by a 34.4 m increase in the 6-minute walk distance compared to just 1.0 m in the placebo group, indicating its efficacy in enhancing physical performance.

Sotatercept also showed significant improvements across multiple secondary endpoints related to pulmonary health, although it was associated with some adverse effects like epistaxis and increased blood pressure, highlighting the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension. Hoeper, MM., Badesch, DB., Ghofrani, HA., et al.[2023]

The phase 3 STELLAR trial indicated that adding sotatercept to background therapy for pulmonary arterial hypertension (PAH) significantly increases life expectancy, with an estimated gain of 11.5 years per patient compared to background therapy alone.

Sotatercept also reduces the need for infused prostacyclin treatments, hospitalizations due to PAH, and the number of lung/heart-lung transplants required, suggesting it may improve overall patient management in PAH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population Health Model Predicting the Long-Term Impact of Sotatercept on Morbidity and Mortality in Patients with Pulmonary Arterial Hypertension (PAH). McLaughlin, V., Alsumali, A., Liu, R., et al.[2023]

Pulmonary hypertension (PH) is a serious complication of connective tissue diseases (CTD), particularly prevalent in systemic scleroderma, and is associated with a poor prognosis, highlighting the importance of early diagnosis.

Current treatments for PAH-CTD include various classes of medications such as prostacyclin derivatives, nitric oxide stimulators, and endothelin receptor antagonists, with ongoing research into new therapies like sotatercept, which may improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent Advances in the Treatment of Pulmonary Arterial Hypertension Associated with Connective Tissue Diseases. Smukowska-Gorynia, A., Gościniak, W., Woźniak, P., et al.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Sotatercept for the treatment of pulmonary arterial hypertension: PULSAR open-label extension. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Sotatercept for the Treatment of Pulmonary Arterial Hypertension. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effects of sotatercept on haemodynamics and right heart function: analysis of the STELLAR trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

In symptomatic PAH, adding sotatercept to stable background therapy improved 6-min walk distance at 24 wk. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Population Health Model Predicting the Long-Term Impact of Sotatercept on Morbidity and Mortality in Patients with Pulmonary Arterial Hypertension (PAH). [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Recent Advances in the Treatment of Pulmonary Arterial Hypertension Associated with Connective Tissue Diseases. [2023]