Condition: Nonalcoholic steatohepatitis
Key Inclusion Criteria:
- 18-75 years old (females must not be pregnant or lactating)
- 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
- Must meet all components of screening lab panel
- Biopsy-proven nonalcoholic steatohepatitis (NASH)
Key Exclusion Criteria:
- Weight gain or 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 diabetes or uncontrolled Type 2 diabetes
A Phase II-III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH) (IRB no. 00001265)
The purpose of this study is to evaluate the effectiveness and safety of an experimental drug called efruxifermin (EFX) in patients with nonalcoholic steatohepatitis (NASH). NASH is a condition in which there is an increased amount of fat, inflammation and scarring in the liver. EFX is designed to reduce these changes in the liver; the drug is made by modifying a naturally occurring hormone in the body that affects the balance of metabolism.
Participants will be randomly assigned to 1 of 3 treatment groups. Group 1 will receive placebo (inactive substance); Group 2 will receive 28 mg of EFX; and Group 3 will receive 50 mg EFX.