Note: This study is currently only recruiting patients in the hospital.

If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.

Do you have non-alcoholic fatty liver disease?

We are recruiting patients to participate in a clinical trial testing the safety and efficacy of Elafibranor in people with non-alcoholic steatohepatitis (NASH). The treatment period lasts 72 weeks while taking this oral medication.

Massachusetts General Hospital Liver Diseases Clinical Trials
11 visits over 4 years
Estimated Time Commitment
Male, Female, 18-75 years
May Be Eligible
Non-payment compensation
May Be Offered
Blood draw, Medication, Office visit, Biopsy
May Be Required
 
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This project is not recruiting.

Overview

What we are studying

We are studying a new medication, Elafibranor, and its ability to safely treat patients with non-alcoholic steatohepatitis (NASH) and fibrosis. It has already passed through Phase II and is now in Phase III of FDA clinical trials. The study involves liver biopsies, blood/urine tests and multiple visits to MGH over the course of screening, treatment, and long-term follow up. Phase II studies indicated promise in resolving NASH in some patients.


Why it is important

There are not currently any quality treatment options for individuals with non-alcoholic steatohepatits.  This experimental medication is in the first wave of drugs to be tested for use in this disease.


What we hope to accomplish

We hope that this medication resolves non-alcoholic steatohepatitis and that it resolves NASH safely with minimal side-effects.

Principal Investigator

Kathleen Corey, MD

Massachusetts General Hospital

Public Profile

Who can participate

Males or females from age 18 to 75 with non-alcoholic steatohepatitis (NASH) and stage 2 or 3 fibrosis. Patients must be willing and able to undergo a liver biopsy at screening (if they have not had a biopsy within 6 months of screening).

What you may be asked to do

Provide blood and urine samples, undergo liver biopsies, have height, weight, and vital signs measured, and come in for visits to MGH.


Project activities may include:

  • Blood draw
  • Medication
  • Office visit
  • Biopsy

Estimated Time Commitment

11 visits over 4 years

What You May Get

Participants will receive up to $50 to cover the costs of transportation to and from study visits.

Location

Massachusetts General Hospital
GI Associates, Blake 455 Fruit St. Boston, MA 02114

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Travel

  • Accessible by public transportation
  • Out of state travel possibly reimbursed
  • Parking reimbursed
  • Local travel reimbursed

Travel and Parking Details

Additional Information

ClinicalTrials.gov Identifier

NCT02704403


Study Phase

Phase 3: This project studies a drug or treatment that has already been studied for safety and effectiveness in both healthy volunteers and participants with specific diseases or conditions. It will gather more information about safety and effectiveness. It may look specifically at different groups of people, different dosages, or different combinations of medications or treatments.


Participating Institutions


Funding Source

  • Industry
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