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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

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

HYPERION Trial 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.

HYPERION Trial 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.

Select...

I am 18 years old or older.

Select...

My pulmonary arterial hypertension is moderate to severe.

HYPERION Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of randomization to the time of first clinical worsening event (up to approximately 47 months)

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

Injection site pain

Hypokalaemia

Rash

Flushing

Oedema peripheral

Thrombocytopenia

Nasopharyngitis

Urinary tract infection

Dyspnoea

Inguinal hernia

Pulmonary arterial hypertension

Atrial flutter

Iron deficiency

Bronchitis

Fall

Supraventricular tachycardia

Abdominal pain

Pancreatitis

Cellulitis

Pneumonia

Pneumonia influenzal

Respiratory tract infection

Sepsis

Upper respiratory tract infection

Osteoporotic fracture

Acute kidney injury

Haemoptysis

Pulmonary artery aneurysm

Upper gastrointestinal haemorrhage

Joint injury

Sjogren's syndrome

Cerebral haematoma

Device malfunction

Nephritis

Sarcoidosis

Gastroenteritis viral

100%

80%

60%

40%

20%

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)

HYPERION 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

~680

0 / 3Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for participants in this research?

"The latest information on clinicaltrials.gov indicates that this study is actively recruiting patients. This trial was originally posted on March 18th, 2022 and the listing was updated on November 11th, 2022."

Answered by AI

What is the existing research on Sotatercept?

"There are presently 4 active clinical trials involving Sotatercept, 3 of which have reached Phase 3. Most research teams studying Sotatercept are based in Edmonton, Canada; however, there are 492 locations worldwide conducting similar studies."

Answered by AI

How many people are being signed up for this clinical trial?

"In order to carry out this study, 662 patients that meet the pre-defined inclusion criteria are required. These individuals can participate in the trial at St Boniface General Hospital (Site 2106) in Winnepeg, Manitoba and Sir Mortimer B. Davis Jewish General Hospital (Site 2103) in Montreal, Quebec among other locations."

Answered by AI

What are the main goals that researchers are hoping to achieve with this clinical trial?

"The primary goal of this study, which will be measured over the course of approximately 56 months, is to track Time to Clinical Worsening. This is defined as the first confirmed morbidity event or death. Secondary outcomes include Percentage of Participants who Improve in WHO FC or Maintain WHO FC II at 24 Weeks from Baseline and Change from Baseline in the Cognitive/Emotional Impacts Domain Score of PAH-SYMPACT®."

Answered by AI

What is the official stance of the FDA on Sotatercept?

"Sotatercept has been studied enough that its safety can be estimated to be a 3."

Answered by AI

Does this trial explore new territory in the medical field?

"As of now, there are 4 ongoing trials for Sotatercept being conducted in 182 cities and 28 countries. The first study was completed in 2021 by Acceleron Pharma Inc. and had 700 participants. It successfully completed Phase 3 drug approval. Since then, 18294 more studies have been completed."

Answered by AI

How many different sites are using this clinical trial to test treatments?

"This study is being conducted out of St Boniface General Hospital (Site 2106) in Winnepeg, Manitoba, Sir Mortimer B. Davis Jewish General Hospital (Site 2103) in Montreal, Quebec, and University of California San Diego Medical Center in La Jolla, California along with 23 other locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)

2022. "Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04811092.

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