What is MASH/NASH Fibrosis?
MASH, or Metabolic Dysfunction-Associated Steatohepatitis, is a chronic liver disease. MASH is caused by the buildup of fat in the liver leading to inflammation and damage. If left untreated, MASH can cause scarring (fibrosis) and eventually cirrhosis.
MASH is an advanced form of the common MASLD, metabolic dysfunction-associated steatotic liver disease. About 20% of people with MASLD develop MASH. It is most common in people who are obese and/or have Type 2 diabetes.
MASH was previously known as NASH, or Nonalcoholic Steatohepatitis. In an effort to destigmatize the disease, researchers and medical professionals agree that MASH is a more accurate description. This name drives the focus to the metabolic origins of the disease rather than the nonalcoholic component.
During this time of transition between names, both NASH and MASH are acceptable and can be used interchangeably.
There are currently very few approved treatments or therapies for MASH or MASLD but studies like ENLIGHTEN Fibrosis are working to change that. Take the pre-screener to see if you may qualify and can help others who are impacted by MASH in the future.
How do I know if I can join the ENLIGHTEN Fibrosis study?
You may be able to join the study if you meet the following requirements:
- Age 18-75 or //Age range specified in protocol //
- Willing to undergo a biopsy of the liver to confirm MASH/NASH and again after 12 months and 36 months of treatment
- Confirmed diagnosis of MASH/NASH with F2 or F3 Fibrosis
Other study requirements will apply
What will happen during the study?
Participation in the ENLIGHTEN Fibrosis study will last a minimum of 40 months (about 3 and a half years). Here is what you can expect if you enroll in the ENLIGHTEN Fibrosis study:
| Review & Sign the Informed Consent Form | The Informed Consent Form (ICF) contains information about the study including its goals, duration, benefits, risks, tests, and procedures. |
| Screening Period (about 12 weeks) | Receive study health assessments to confirm if you qualify for the study.
The final step of screening will consist of a liver biopsy that will be used to qualify for the study and as the baseline prior to study treatment. |
| Research Medication Period (36 months with possible extension) | · You will be assigned at random to receive either pegozafermin or a placebo (no active medication)
· You will receive injections of pegozafermin or placebo into your belly (first given by a nurse at the study clinic and then given by yourself or a caregiver at home) either weekly or every 2 weeks, depending on your assigned schedule. · You will have study health checks about every 2 to 3 months for the first year, then alternate phone calls and visits every 3 months for 2 more years · You will follow instructions for diet, activity level, and alcohol use throughout the study |
| Follow-up Period (3 weeks) | Visit the study clinic 3 weeks after you stop taking pegozafermin or placebo for study health checks. |
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
Travel and reimbursement may be available for participating in the study.
Want to be a part of the ENLIGHTEN Fibrosis study?
Take the pre-screener to see if you may qualify!
//or//
Find a study clinic near you
About Pegozafermin
What is Pegozafermin?
Pegozafermin is a research medication being developed to potentially decrease the inflammation and scarring of the liver that is caused by MASH/NASH. It is a lab-made version of a hormone that the body naturally produces to help process and store fats and sugars in the blood and organs. Researchers believe that pegozafermin may help the body manage fats and sugars better so less fat builds up in the liver.
Pegozafermin is investigational. This means that it is not approved by any health or regulatory agencies. It can only be used in clinical research.
Will I receive the study drug?
If you join the study, you will be assigned at random to a group that receives pegozafermin or to a group that receives placebo. Placebo looks like pegozafermin but has no active drug, so researchers can compare results across groups.
You will have a 2 in 3 chance of being assigned to pegozafermin, but you will not know your assignment.
Participants will be placed at random in 1 of 4 groups:
- Receive pegozafermin dose weekly
- Receive pegozafermin dose once every 2 weeks
- Receive placebo dose weekly
- Receive placebo dose once every 2 weeks
What is a “research medication?”
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like ENLIGHTEN Fibrosis.
For more information on MASH/NASH and the name change, check out:
- NEJM
- AASLD
- Fatty Liver Alliance
- Cleveland Clinic
- National Institute of Health
Overview of Clinical Trials
Here are some common questions and answers about study participation.
What are clinical research studies (trials)?
Clinical research studies are designed to answer specific questions about the safety or effectiveness of investigational drugs, vaccines, other experimental approaches, or new ways of using existing treatments. Studies are important for medical advancement. Current treatments for diseases and conditions are available because of study volunteers, and what we learn from the ENLIGHTEN Fibrosis study could help accelerate the development of new therapies and inform future research, which may help the MASH/NASH community in the future.
What is informed consent?
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
What does study participation involve?
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
If you have additional questions about participating in a clinical research study, contact a study clinic near you/talk to your doctor for additional information.
Study Clinic Locations
Find a study clinic near you!
Use the filters, map, and listing to find the study clinic closest to you. Contact the study clinic to learn more.