MASH Research Study
The Enlighten Fibrosis study is a clinical research study for adults with Metabolic Dysfunction Associated Steatohepatitis (MASH).
What is the trial about?
MASH stands for Metabolic Dysfunction Associated Steatohepatitis. It used to be called NASH, or Non-Alcoholic Steatohepatitis. MASH is caused by having too much fat in the liver. It's normal for the liver to have some fat, but too much fat can cause harmful damage like liver scarring (fibrosis). If fat continues to build up, it can lead to extreme scarring (Cirrhosis) or liver failure.
The goal of this study is to find out if the study medicine can reduce the harmful effects of MASH, including liver scarring.
Are you overweight? Do you have High Blood Pressure, High Triglycerides, High Blood Sugar or Fatty Liver Disease? If so you, you may have MASH and be eligible for this study
Meet your Investigator for this study
With you every step of your clinical trial journey, your Principal Investigator for this study is:
Dr Andreas Hajineocli
Clinical Research Physician
Who can participate in the trial?
You may be able to join this study if you are an adult diagnosed with MASH and liver scarring (Fibrosis).
If you do not know whether you have MASH or liver scarring, the study doctor can help you find out.
What is the study process?
The Study Screening Period(12 weeks)
- Visit the study clinic several times for study health checks to find out if you qualify
- Have a liver biopsy if you have not had one in the 6 months before Screening
Study Medicine Period(3 Years)
- Receive weekly or bi-weekly (2 weeks) injections of the study medicine
- Injections are given under the skin of your belly area
- A nurse gives the first injections at the study clinic. Then, you or a caregiver can betrained to give injections at home.
- Have study health checks about every 2 to 3 months
- Women who could become pregnant will have a urine pregnancy test at almost every clinic visit. Home testing kits will be provided for monthly tests if the interval between site visits is longer than a month. You will be asked to share the results with your study doctor.
- Follow instructions for diet, activity level and alcohol use throughout the study
Follow-Up Period(3 weeks)
- Visit the study clinic for study health checks 3 weeks after you stop taking the study medicine
What can you expect as compensation?
This will be discussed with you by the study team
FAQs
Do you have further questions?
Please contact the respective study site(s) for questions:
Teesside
E-mail:
northtees@futuremeds.com
