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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 43 months
Awards & highlights

ZENITH Trial Summary

This trial is testing a new drug to see if it can help people with a certain kind of heart problem.

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.Check my eligibility
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.See study design
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.

ZENITH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.

ZENITH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 43 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 43 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 First Confirmed Morbidity or Mortality Event
Secondary outcome measures
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 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%
Inguinal hernia
1%
Atrial flutter
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)

ZENITH 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
~680

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

Placebo (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04896008 — 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: NCT04896008 — Phase 3
Placebo (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04896008 — Phase 3
Pulmonary Arterial Hypertension Patient Testimony for trial: Trial Name: NCT04896008 — 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 other notable examples of Sotatercept's efficacy?

"Currently, there are five clinical trials studying Sotatercept with four of them in Phase 3. While a few of the Sotatercept trials are situated in Tours, Indre-et-Loire, there are a total of 714 sites running these sorts of studies."

Answered by AI

When might Sotatercept receive FDA approval?

"Sotatercept's Phase 3 status indicates that, while there is some evidence of efficacy, the primary focus is on safety. Therefore, it receives a score of 3."

Answered by AI

Could you inform me of how many different hospitals are conducting this research?

"To date, this clinical study has recruited patients from 24 different locations, including Peter Lougheed Centre ( Site 2102) in Calgary, Alberta, University of Cincinnati Medical Center ( Site 1035) in Cincinnati, Ohio, and Arizona Pulmonary Specialists ( Site 1010) in Phoenix, Arizona."

Answered by AI

Will this study's benefits be reaped by those who are not yet of retirement age?

"This trial is only for adults aged 18-75. There are 55 other trials for minors and 693 for seniors."

Answered by AI

Who can join this clinical trial and start receiving treatment?

"This study is investigating a potential new treatment for pulmonary arterial hypertension. To be eligible, patients must be between 18-75 years old. So far, 200 patients have been enrolled in the clinical trial."

Answered by AI

Are there any current vacancies for patients in this clinical trial?

"The online clinical trials database indicates that this study is actively recruiting participants. The listing was first posted on December 1, 2021 and was last updated on October 28, 2022."

Answered by AI

What is the therapeutic goal of this clinical trial?

"The primary outcome of this trial is to evaluate Time to first confirmed morbidity or mortality event over a period of up to approximately 46 months. The secondary outcomes include Transplant-free survival, which is defined as Time from randomization to lung transplantation or death from any cause, Change from baseline in EuroQoL-5 dimensions scale 5 levels (EQ-5D-5L) index score at Week 24, which is defined as EQ 5D 5L index score measures health-related quality of life states in adults, and Change From Baseline in EuroQoL-5 Dimensions Scale 5 Levels (E"

Answered by AI

What is the largest number of people who can join this clinical trial?

"Yes, the information available on clinicaltrials.gov supports that this study is currently looking for test subjects. The trial was first announced on December 1st, 2021 and has had one edit on October 28th, 2022. They are looking for 200 participants total, which will be drawn from 24 different hospitals."

Answered by AI

Have there been any other similar clinical trials like this one before?

"Sotatercept's journey begins in 2021 with the first clinical trial. This study, which had 324 participants, was sponsored by Acceleron Pharma Inc. Following the success of this initial Phase 3 drug trial, Sotatercept received approval and 5 active studies involving the medication popped up in 28 countries across 205 cities."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
Medical College of Wisconsin - Froedtert Hospital ( Site 1051)

Why did patients apply to this trial?

I've never been given any drugs. To become more educated about my diagnosis and treatment plan the more I know the more healthy I am.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)
2021. "A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04896008.
All > Pulmonary Arterial Hypertension > Pulmonary Hypertension
~59 spots leftby Sep 2025
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