Join the search for a way to manage NASH

NASH (nonalcoholic steatohepatitis) occurs when too much fat builds up in the liver and causes liver damage. NASH doesn’t have many symptoms, which makes it hard to diagnose. It can lead to other complications, like liver failure and heart attack. A clinical study by 89Bio is researching a treatment that may help those living with NASH.

The ENLIVEN Study is exploring how well a study medicine may treat liver damage caused by NASH. It’s now enrolling adults between the ages of 21 and 75. You may be eligible if you have NASH or NASH risk factors. If you’re interested, please speak to a member of our study team to learn more.

What are the risk factors of NASH?

  • Type 2 diabetes
  • Body mass index (BMI) over 30
  • High blood pressure
  • Heart disease
  • Obstructive sleep apnea
  • High cholesterol

Who can participate?

You may qualify to join the ENLIVEN Study if you:

  • Are between the ages of 21 and 75
  • Have obvious signs of NASH from prior medical testing, including blood tests, imaging scans, and/or a liver biopsy that show F2-F3 fibrosis (liver damage)
  • Have prior medical testing that shows high amounts of fat buildup in the liver
  • Have one or more of the following:
    • Body mass index (BMI) over 30
    • Type 2 diabetes
    • High triglycerides (a type of fat in the blood often measured with cholesterol)
    • Low HDL (good) cholesterol
    • High blood pressure

What is the ENLIVEN Study?

ENLIVEN is a clinical research study for people with NASH. The goal of this study is to see if the study medicine, BIO89-100, is safe and effective compared to a placebo at helping you improve your liver tissue.

Clinical research studies test whether a study medicine is safe and improves people’s health. Before any medicine is approved and available to the public, it goes through several phases in clinical research.

What is included in study participation?

If you are eligible and choose to participate, you will receive the study medicine and study-related visits, tests and assessments at no cost. You may also be reimbursed for study-related travel expenses.

What is the study medicine?

The study medicine, BIO89-100, is an investigational study medicine. It is designed to help you repair liver tissue. “Investigational” means that the study medicine has not been approved for public use. It can only be used in research studies.

You will receive either BIO89-100, or placebo (no active medicine) through subcutaneous (under the skin) injections that are taken weekly or every two weeks in the stomach.

What can study participants expect?

If you qualify and decide to join the study, your participation will last up to 64 weeks and includes the following:

Screening Period (up to 12 weeks):

  • Have testing done to see if you qualify for the study

Main Study Treatment Period (24 weeks):

  • Be randomly assigned to receive either the study medicine or placebo.
  • Visit the clinic 7 times to receive health assessments. These help the study team monitor your health and how you are responding to the study medicine or placebo.
  • Receive 5 home care assistance visits
  • Take the study medicine once a week or every two weeks by subcutaneous injections.
  • The study team will teach you how to prepare and administer the at-home injection.

Extended Study Treatment Period (24 Weeks):

  • Be randomly assigned to receive either the study medicine or placebo.
  • Take the study medicine once a week or every two weeks by subcutaneous injections.

Follow-up Period (4 weeks):

  • Have a final phone visit.

How can I get involved?

Only the study doctor can confirm if you qualify, to see if you qualify please call (318) 525-3233 to speak with a member of our study team to schedule a visit.