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Sotatercept for Pulmonary Arterial Hypertension (HYPERION Trial)

Phase 3
Recruiting
Research Sponsored by Acceleron Pharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented diagnostic right heart catheterization (RHC) within 12 months of screening documenting a minimum PVR of ≥ 4 Wood units and pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) of ≤ 15 mmHg, with the diagnosis of WHO PAH Group 1 in specific subtypes
Age ≥ 18 years
Must not have
Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 180 mmHg or sitting diastolic BP > 110 mmHg during the Screening Visit after a period of rest
Hemoglobin at screening above gender-specific upper limit of normal (ULN), per local laboratory test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of randomization to the time of first clinical worsening event (up to approximately 47 months)
Awards & highlights

Summary

This trial is testing a new drug for PAH patients who are at a high risk for disease progression. The drug is being compared to a placebo to see if it can help prevent worsening of PAH.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects for Sotatercept in this context aren't detailed here, similar medications may cause issues like blood pressure changes, fatigue, headache, gastrointestinal discomforts, and potential risks during pregnancy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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I am 18 years old or older.
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My pulmonary arterial hypertension is moderate to severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood pressure is not higher than 180/110 mmHg.
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My hemoglobin level is above the normal range for my gender.
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I have been diagnosed with a specific type of high blood pressure in my lungs.
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I have been diagnosed with a specific type of pulmonary arterial hypertension.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of randomization to the time of first clinical worsening event (up to approximately 47 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of randomization to the time of first clinical worsening event (up to approximately 47 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to Clinical Worsening
Secondary outcome measures
Change from Baseline in 6MWD
Change from Baseline in NT-proBNP Levels
Change from Baseline in the Cardiopulmonary Symptoms Domain Score of PAH-SYMPACT®
+6 more

Side effects data

From 2022 Phase 3 trial • 324 Patients • NCT04576988
20%
Headache
15%
COVID-19
12%
Diarrhoea
12%
Epistaxis
10%
Telangiectasia
10%
Nausea
10%
Fatigue
10%
Dizziness
7%
Injection site pain
6%
Hypokalaemia
6%
Rash
6%
Flushing
5%
Oedema peripheral
5%
Thrombocytopenia
4%
Nasopharyngitis
3%
Urinary tract infection
2%
Dyspnoea
1%
Pulmonary arterial hypertension
1%
Atrial flutter
1%
Inguinal hernia
1%
Iron deficiency
1%
Bronchitis
1%
Fall
1%
Supraventricular tachycardia
1%
Abdominal pain
1%
Pancreatitis
1%
Cellulitis
1%
Pneumonia
1%
Pneumonia influenzal
1%
Respiratory tract infection
1%
Sepsis
1%
Upper respiratory tract infection
1%
Osteoporotic fracture
1%
Acute kidney injury
1%
Haemoptysis
1%
Pulmonary artery aneurysm
1%
Upper gastrointestinal haemorrhage
1%
Joint injury
1%
Sjogren's syndrome
1%
Cerebral haematoma
1%
Device malfunction
1%
Nephritis
1%
Sarcoidosis
1%
Gastroenteritis viral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Plus Background PAH Therapy (DBPC Period)
Sotatercept Plus Background PAH Therapy (DBPC Period)
Sotatercept Plus Background PAH Therapy (LTDB Period)
Placebo Plus Background PAH Therapy (LTDB Period)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sotatercept plus background PAH therapyExperimental Treatment1 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 therapyPlacebo Group1 Intervention
Administered subcutaneously (SC) every 21 days plus background PAH therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotatercept
2019
Completed Phase 3
~690

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Pulmonary Arterial Hypertension (PAH) include endothelin receptor antagonists (ERAs), which block the effects of endothelin-1, a potent vasoconstrictor, thereby reducing blood vessel constriction and lowering blood pressure in the lungs. Phosphodiesterase-5 inhibitors (PDE5Is) work by increasing nitric oxide availability, leading to vasodilation and improved blood flow. Prostacyclin analogs mimic the effects of prostacyclin, a natural vasodilator, and inhibit platelet aggregation, which helps to reduce pulmonary artery pressure. Sotatercept, an investigational drug, acts as an activin receptor type IIA ligand trap, modulating the transforming growth factor-beta (TGF-β) superfamily signaling, which is involved in vascular remodeling and inflammation. These treatments are vital for PAH patients as they target different pathways to alleviate symptoms, improve exercise capacity, and potentially slow disease progression.

Find a Location

Who is running the clinical trial?

Acceleron Pharma Inc.Lead Sponsor
26 Previous Clinical Trials
2,601 Total Patients Enrolled
5 Trials studying Pulmonary Arterial Hypertension
1,317 Patients Enrolled for Pulmonary Arterial Hypertension
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USALead Sponsor
32 Previous Clinical Trials
3,823 Total Patients Enrolled
5 Trials studying Pulmonary Arterial Hypertension
1,317 Patients Enrolled for Pulmonary Arterial Hypertension
Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)Lead Sponsor
32 Previous Clinical Trials
3,823 Total Patients Enrolled
5 Trials studying Pulmonary Arterial Hypertension
1,317 Patients Enrolled for Pulmonary Arterial Hypertension

Media Library

Placebo (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04811092 — Phase 3
Pulmonary Arterial Hypertension Research Study Groups: Placebo plus background PAH therapy, Sotatercept plus background PAH therapy
Pulmonary Arterial Hypertension Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04811092 — Phase 3
Placebo (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04811092 — Phase 3
~201 spots leftby Aug 2026
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