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Sotatercept for Pulmonary Arterial Hypertension (ZENITH Trial)
Phase 3
Waitlist Available
Research Sponsored by Acceleron Pharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Right heart catheterization documenting minimum pulmonary vascular resistance (PVR) of ≥5 Wood units and a pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) of ≤15 mmHg
Male participants must agree to use a condom and refrain from donating blood or sperm
Must not have
Untreated more than mild obstructive sleep apnea
History of restrictive or congestive cardiomyopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 43 months
Awards & highlights
Summary
This trial is testing sotatercept added to current treatments for patients with severe PAH who are at high risk of death. The goal is to see if it can lower lung blood pressure and improve patient outcomes. Sotatercept, which modulates bone morphogenic protein receptor type 2 (BMPR2) signaling, showed promising results in earlier studies.
Who is the study for?
This trial is for adults with severe Pulmonary Arterial Hypertension (WHO FC III or IV) who are at high risk of mortality. They must be on stable PAH medication, not pregnant, and willing to use contraception. Exclusions include certain heart conditions, recent strokes, liver issues, untreated sleep apnea, and previous reactions to sotatercept.
What is being tested?
The study tests if Sotatercept can extend the time before patients with severe PAH experience death, lung transplantation or hospitalization due to worsening PAH compared to a placebo. Both groups will continue their current PAH treatments alongside the trial intervention.
What are the potential side effects?
While specific side effects for Sotatercept in this context aren't listed here, similar medications may cause issues like blood pressure changes, blood disorders, potential harm to unborn babies and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart test shows high lung blood pressure and normal left heart pressure.
Select...
I am a man and agree to use a condom and not donate blood or sperm.
Select...
My pulmonary arterial hypertension is severe, limiting my physical activity.
Select...
My heart condition is confirmed as WHO Group 1 PAH.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have mild or no sleep apnea that hasn't been treated.
Select...
I have a history of heart muscle problems.
Select...
I have had a lung removed.
Select...
I have been diagnosed with a specific type of high blood pressure in my lungs.
Select...
I have never used sotatercept or had an allergic reaction to it or similar drugs.
Select...
My hemoglobin level is above the normal range for my gender.
Select...
I have been diagnosed with a specific type of pulmonary arterial hypertension.
Select...
I have a history of tightness around my heart.
Select...
I have been diagnosed with a rare lung blood vessel disorder.
Select...
I or my family have a history of long QT syndrome or sudden cardiac death.
Select...
I have a serious heart valve problem.
Select...
I am currently on dialysis or might need it in the next year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 43 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 43 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to First Confirmed Morbidity or Mortality Event
Secondary study objectives
Change From Baseline in 6-MWD at Week 24
Change From Baseline in Cardiac Output (CO) at Week 24
Change From Baseline in EuroQoL-5 Dimensions Scale 5 Levels (EQ-5D-5L) Index Score at Week 24
+9 moreSide effects data
From 2022 Phase 3 trial • 324 Patients • NCT0457698820%
Headache
15%
COVID-19
12%
Diarrhoea
12%
Epistaxis
10%
Telangiectasia
10%
Nausea
10%
Fatigue
10%
Dizziness
7%
Injection site pain
6%
Rash
6%
Hypokalaemia
6%
Flushing
5%
Oedema peripheral
5%
Thrombocytopenia
4%
Nasopharyngitis
3%
Urinary tract infection
2%
Dyspnoea
1%
Pulmonary arterial hypertension
1%
Iron deficiency
1%
Inguinal hernia
1%
Atrial flutter
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 (LTDB Period)
Placebo Plus Background PAH Therapy (DBPC Period)
Sotatercept Plus Background PAH Therapy (DBPC Period)
Sotatercept Plus Background PAH Therapy (LTDB Period)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sotatercept plus background PAH therapyExperimental Treatment1 Intervention
Sotatercept at a starting dose of 0.3 mg/kg, with a target dose of 0.7 mg/kg, SC every 21 days plus background PAH therapy
Group II: Placebo plus background PAH therapyPlacebo Group1 Intervention
Placebo 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 prostacyclin pathway agonists (e.g., epoprostenol, treprostinil), which dilate blood vessels and inhibit platelet aggregation; endothelin receptor antagonists (ERAs, e.g., bosentan, ambrisentan), which block endothelin-1, a potent vasoconstrictor; phosphodiesterase 5 inhibitors (PDE5Is, e.g., sildenafil, tadalafil), which enhance nitric oxide signaling to relax blood vessels; and guanylate cyclase stimulators (e.g., riociguat), which increase cyclic GMP to promote vasodilation. Sotatercept, an investigational drug, acts as a ligand trap for TGF-beta superfamily members, potentially improving vascular remodeling and reducing pulmonary arterial pressure.
These treatments are crucial for PAH patients as they target different pathways to reduce pulmonary vascular resistance, improve symptoms, and enhance quality of life.
Find a Location
Who is running the clinical trial?
Acceleron Pharma Inc.Lead Sponsor
26 Previous Clinical Trials
2,879 Total Patients Enrolled
5 Trials studying Pulmonary Arterial Hypertension
1,595 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
4,101 Total Patients Enrolled
5 Trials studying Pulmonary Arterial Hypertension
1,595 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
4,101 Total Patients Enrolled
5 Trials studying Pulmonary Arterial Hypertension
1,595 Patients Enrolled for Pulmonary Arterial Hypertension
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have mild or no sleep apnea that hasn't been treated.My heart test shows high lung blood pressure and normal left heart pressure.I have a history of heart muscle problems.I have had a lung removed.I have been diagnosed with a specific type of high blood pressure in my lungs.I have never used sotatercept or had an allergic reaction to it or similar drugs.Your heart's electrical activity is measured and if it shows a specific pattern (QTcF) longer than 500 milliseconds, you may not be able to participate.I am a man and agree to use a condom and not donate blood or sperm.Your liver tests show high levels of certain enzymes or bilirubin.My hemoglobin level is above the normal range for my gender.My pulmonary arterial hypertension is severe, limiting my physical activity.Your blood pressure is too low at the start of the study.I have been diagnosed with a specific type of pulmonary arterial hypertension.I have a history of tightness around my heart.I have been diagnosed with a rare lung blood vessel disorder.I have had heart disease symptoms in the last 6 months.I've been on a stable dose of my PAH medication for at least 30 days.I am able to become pregnant and agree to use birth control and undergo regular pregnancy tests.I have not had a stroke in the last 3 months.You have a REVEAL Lite 2.0 risk score of 9 or higher.I or my family have a history of long QT syndrome or sudden cardiac death.I have a serious heart valve problem.My heart's pumping ability is below 45% as per my last year's echo test.Your platelet count is less than 50,000/mm3 before starting the study.I am currently on dialysis or might need it in the next year.My heart condition is confirmed as WHO Group 1 PAH.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo plus background PAH therapy
- Group 2: Sotatercept plus background PAH therapy
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Pulmonary Arterial Hypertension Patient Testimony for trial: Trial Name: NCT04896008 — Phase 3
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