ELEVATE 1 Study

The ELEVATE 1 clinical study will help researchers understand if RVT-1201 is safe and may be a treatment option for people living with PAH. The ELEVATE 1 clinical study is being conducted to help answer several questions researchers have: 

RVT-1201 

RVT-1201, the ELEVATE 1 Study medicine, has the potential to be a new way to treat PAH. RVT-1201 uses a process called tryptophan hydroxylase (TPH) inhibition to reduce the amount of serotonin the body produces. RVT-1201 is given orally as a tablet. 

Why focus on reducing the amount of serotonin the body produces? Research has shown that serotonin can play a role in the development of PAH.

Serotonin is a substance that occurs naturally in your body. It is mainly found in your brain and digestive tract and appears to affect and/or regulate a number of body functions. It is thought that too much serotonin may cause arteries in the lungs to narrow.

Doctors hope the ELEVATE 1 Study medicine, RVT-1201, can reduce the amount of serotonin affecting the lung arteries, which may open the arteries to allow blood to flow more easily.
 

Healthy artery

Artery of person with PAH

Who is Eligible to Join? 

The ELEVATE 1 Study will enroll approximately 40 men and women in the United States and Canada, ages 18 – 75. There are requirements for joining the study to make sure the right participants enter the study and stay safe. 

Requirements to join the study include the following: 

     Confirmed diagnosis of PAH by right heart cardiac catherization

     Agree to undergo a six-minute walk distance test, and achieve study-specific results

     Have been taking other PAH medicines for at least three months that can include:

o   Endothelin Receptor Antagonists (ERAs)

▪      Ambrisentan (Letairis®)

▪      Bosentan (Tracleer®)

▪      Macitentan (Opsumit®)

  Phosphodiesterase Inhibitors (PDE 5 Inhibitors)

▪      Sildenafil (Revatio™)

▪      Tadalafil (Adcirca®)

o   Soluble Guanylate Cyclase (sGC) Stimulators

▪      Riociguat (Adempas®)


People with PAH will not be able to participate in the study if they: 

     Have HIV, portal hypertension or schistosomiasis

     Have been hospitalized for pulmonary hypertension within the past three months

     Are currently taking any of the following medications:

o   Remodulin® or Uptravi®

o   Digox®, Lanoxin® or Digitek®

o   Monoamine oxidase inhibitors (MAOIs), such as Emsam®, Marplan®, Nardil®, or Parnate®

     Have suffered a heart attack or stroke within the past three months

     Have uncontrolled atrial fibrillation (AFib) or other uncontrolled arrhythmias


The study team will evaluate several other factors that will determine if you are eligible to participate in ELEVATE 1 Study.

Talk to your doctor to see if the ELEVATE 1 Study is an option for you. Your doctor knows you and your medical history and can help evaluate if you are eligible to participate in this study. When you talk to your doctor about the study, it is helpful to bring someone with you who can help take notes and ask questions.  

Study Details 

Every clinical research study is different. Below are some more details about the ELEVATE 1 Study. When considering joining a study, ask your doctor for more information about what to expect.

Duration 

12 Weeks long
(6 weeks of treatment) 

Study medication 

RVT-1201
or placebo 

Phase 

Phase 2a
Study

Cost to join study 

No cost for
joining study  

For physicians and others who would like more details about this study, please visit www.ClinicalTrials.gov

Study Sponsor  

The ELEVATE 1 Study is sponsored by Altavant Sciences, GmbH (Altavant), a clinical stage biopharmaceutical company formed to advance therapies in areas of high unmet medical need, with an initial therapeutic focus in PAH. To learn more about Altavant, visit www.altavant.com

Frequently Asked Questions About the ELEVATE 1 Study 

Where is the ELEVATE 1 Study taking place?
Study centers are opening at medical centers in the United States and Canada.
   
How do I join the ELEVATE 1 Study?
Find a study center and doctor near you and talk to your doctor to see if the ELEVATE 1 Study is an option for you. Your doctor knows you and your medical history and can help evaluate if you are eligible to participate in this study.
   
Will I be given a placebo in the ELEVATE 1 Study?
In the ELEVATE 1 Study, which is a randomized study, you will continue your current medications and will be assigned to receive either the investigative medicine or placebo by chance.
   
Do I have to pay to join the ELEVATE 1 Study?
No, there is no cost to join the ELEVATE 1 Study. The study medicine (RVT-1201 or placebo), study visits, study-related tests and study-related procedures will be provided at no cost to you. However, care that may be considered ‘routine’ may be billed to you or your insurance provider. Routine care costs refers to care you would receive regardless of whether you participate in the study or not.

The study sponsor, Altavant, is providing study participants with a modest stipend for participation-related expenses. Reimbursement for travel may be available.

Doctors and hospitals who participate in clinical studies are paid for their time by the study sponsor because it is a research study and not part of regular patient care.

   
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