A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)

Launched by AKERO THERAPEUTICS, INC · Feb 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called efruxifermin (EFX) for people with a liver condition known as nonalcoholic steatohepatitis (NASH). NASH is a type of liver disease that can lead to serious liver damage and is often associated with issues like obesity and diabetes. The trial is specifically looking at individuals who have confirmed NASH and are in the early stages of liver fibrosis (which is scarring of the liver) but do not have cirrhosis (advanced liver disease). Participants are randomly assigned to receive either the study drug or a placebo (a treatment that looks like the drug but has no active ingredients) to see how well it works.

To be eligible for this trial, participants must be between 18 and 75 years old and have a history of certain health conditions, such as obesity or high blood sugar. They must also have specific results from a liver biopsy that confirms the presence of NASH. The trial is currently active but not recruiting new participants. If someone joins, they can expect to undergo regular check-ups and tests to monitor their health throughout the study. It’s important for potential participants to know that certain health issues, like advanced liver scarring or significant weight loss in recent months, may prevent them from being eligible.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Males and non-pregnant, non-lactating females between 18 - 75 years of age inclusive, based on the date of the screening visit.
• • Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.
• • FibroScan® measurement \> 8.5 kPa.
• * Biopsy-proven NASH. Must have had a liver biopsy obtained ≤ 180 days prior to randomization with fibrosis stage 2 to 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:
• • Steatosis (scored 0 to 3),
• • Ballooning degeneration (scored 0 to 2), and
• • Lobular inflammation (scored 0 to 3).
• Exclusion Criteria:
• • Weight loss \> 5% in the 3 months prior to screening until randomization or from the time of the diagnostic liver biopsy until randomization, whichever is longer.
• • Presence of cirrhosis on liver biopsy (stage 4 fibrosis).
• • Type 1 or uncontrolled Type 2 diabetes.
• • Other inclusion and exclusion criteria may apply.