Have You Been Struggling to Improve Your Liver Health?
Consider taking part in the SYNCHRONY Histology study of an investigational drug for people with nonalcoholic steatohepatitis (NASH), which is also sometimes called MASH (metabolic-dysfunction associated steatohepatitis)
Histology is the study of tissue—in this case, liver tissue—under a microscope. Everyone in the SYNCHRONY Histology study will need to have had a liver tissue sample (called a biopsy) or complete one during screening that shows they have NASH/MASH. The study will test an investigational drug called efruxifermin (EFX) to see whether it helps slow down or possibly reverse scarring of the liver and to learn about any side effects.
Clinical trials encourage everyone with the disease (or that suspect they have the disease) to participate to advance treatment for everyone with non-alcoholic fatty liver disease (NAFLD), sometimes called metabolic-dysfunction associated steatotic liver disease (MASLD).
You may be able to take part in the SYNCHRONY Histology study if you:
- Are 18 to 80 years old
- Have had a liver biopsy that showed NASH/MASH or are willing to undergo a biopsy
- Have or have ever had type 2 diabetes or 2 out of 4 signs of metabolic disease (overweight, have high cholesterol, blood pressure, and/or blood glucose)
- Have a body mass index (BMI) ≥25.0 kg/m2
There are other requirements for participation in the study. Please ask for details.
The SYNCHRONY Histology study includes:
- Screening period: 12 weeks
- Treatment period: 96 weeks
- Follow-up period: 30 days
Everyone in the study will need to have had a liver tissue sample (biopsy) or complete one during screening that shows they have NASH/MASH.
Participants in the SYNCHRONY Histology study will be randomly assigned (as if by drawing names from a hat) to get either EFX 28 mg, EFX 50 mg, or placebo, which is a liquid that looks like EFX but has no active ingredients. Whichever group you are in, you will give yourself an injection once a week, along with taking your usual medications.
There is a 66% chance (2/3) of getting EFX, but you will not be able to choose. Neither you nor the study team working with you will know whether you are getting EFX or placebo.
Non-cirrhotic nonalcoholic steatohepatitis (NASH/MASH) is a type of NAFLD/MASLD. The condition starts with a build-up of fat in the liver, damage to liver cells, and soreness, which eventually leads to scarring. Almost 80 million people in the United States are living with NAFLD/MASLD, and about 1 in 5 are expected to end up with NASH/MASH. To reduce the risk of liver failure, the first advice doctors give their patients with NAFLD/MASLD and NASH/MASH is to eat healthier foods and get more exercise. But these changes are not enough to help many people who have this form of liver disease.
Clinical research studies are needed to find out whether an investigational drug is safe and works to treat a certain condition or a certain group of patients.
During a study, researchers record information about the effects of the drug being studied. Once the study is completed, specially trained government officials carefully review the information. They then decide whether the investigational drug can or cannot be used by the public, or if more research is needed.
Strict rules must be followed during clinical research studies to help protect the rights, safety, and privacy of the people taking part. The rules also make sure the studies are done ethically and meet approved medical standards.
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Frequently asked questions
A study (also called a clinical trial) is medical research that helps answer important questions about an investigational drug. These may include how well the study drug works for a certain condition or in a certain group of people (for example, a certain age group). All medications must be tested in clinical research studies before they can be approved and prescribed to patients.
The SYNCHRONY Histology Study is testing an investigational drug called efruxifermin (EFX), given as a weekly injection in adults who have NASH/MASH.
Taking part in the SYNCHRONY Histology study will last up to 112 weeks.
During the screening period, which will last up to 12 weeks, you will have tests and procedures done to see if you are a good match to receive study drugs.
If you qualify, you will be randomly assigned (as if by drawing names from a hat) to get either EFX 28 mg, EFX 50 mg, or placebo, which is a liquid that looks like EFX but has no active ingredients.
Both EFX and placebo will be administered by injection once a week. Your study doctor will teach you how to give yourself the injection.
Taking part in any clinical study is completely up to you. Your decision to participate —or not to participate — in this study will have no effect on your usual medical care now or in the future. If you qualify and choose to take part, you may leave the study at any time and for any reason.
If you take part in a SYNCHRONY Histology study, reimbursement may be available to you for reasonable study-related expenses.
There is no cost to take part in a SYNCHRONY Histology study. If you decide to take part:
- You will receive study-related care from a team of experienced doctors and nurses throughout the study.
- All study-related visits, tests, and study drugs (EFX or placebo) will be given to you at no cost.
The research team will explain more about what the SYNCHRONY Histology study involves, and it is up to you to decide if you want to take part. Taking part is voluntary. Whether you decide to participate will not affect your current or future relationships with your usual doctors. If you decide to participate, you are free to leave the study any time without affecting those relationships.
We match you to a study site within close travel distance to your home. If we are not currently conducting the study in your area, with your permission, we will keep your information on file. We'll reach out to you once a study site becomes available in your area. If, at any time, you decide you no longer want your information stored, you can opt out, and we will promptly delete your information.
Participating in a study allows you to get more involved in your own health by getting a new study treatment for a disease or condition you have. Participants also play an important role in possibly bringing a much-needed drug to the public, possibly benefiting other people who have the same disease or condition. In some cases, this can be life changing. Participants may be reimbursed for reasonable study-related expenses.
Every clinical trial is watched over by government officials to make sure the risks are as low as possible and are balanced out by the possible benefits to the study participant. As a volunteer, you have the right to leave the study at any time and for any reason, with no penalty or loss.
