Akero 105 (Metabolic Dysfunction-Associated Steatohepatitis) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called efruxifermin (EFX) is a safe and effective option for people who have nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH) and liver fibrosis (scarring of the liver tissue).
Metabolic Dysfunction-Associated Steatohepatitis (MASH) /Nonalcoholic Steatohepatitis (NASH)
Who Can Participate in the Study?
Adults ages 18-80 who:
- Are diagnosed with MASH/NASH
- Have a diagnosis that is proven by biopsy
- Have a history of Type 2 Diabetes
For more information, contact the study team at adele.gaskin@duke.edu.
What is Involved?
If you choose to join this study, you will get a random assignment (by chance) to 1 of 3 groups. Depending on your assignment, you will:
- Get a 28mg dose of EFX; OR
- Get a 50mg dose of EFX; OR
- Get a placebo (inactive substance that has no drug in it)
You will take EFX or placebo for up to 96 weeks. Participation in the study will last for about 112 weeks. You will visit our clinic 24 times during the study, and the following procedures will be done over the course of the study: blood draws, liver biopsies, DXA scans, ultrasounds, and surveys.
Study Details
