This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind,
placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.

A Study Evaluating Efruxifermin in Subjects with Compensated Cirrhosis Due to NASH/MASH

NASH - Nonalcoholic Steatohepatitis

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Efruxifermin

Placebo

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Compensated Cirrohosis Due to NASH/MASH

Based on NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no
fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal
fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)

ELF (scale of 6.7 to 11.3 with higher scores indicative of increased fibrosis)

Liver stiffness assessed by transient elastography (FibroScan®) (kPa)

FAST score (varied on a scale from 0 to 1, with the patients being classified as having
low [<0.35], intermediate [0.35-0.67], or higher [>0.67] probability of having
significant inflammatory activity and fibrosis)

Total cholesterol (mg/dL), Triglycerides (mg/dL), HDL-C (mg/dL), Non-HDL-C (mg/dL), and
LDL-C (mg/dL)

HOMA-IR (≥ 2.5 indicates insulin resistance)

Based on NAS (scored by 0-1 for steatosis, 0-3 for inflammation, and 0-2 for ballooning)

Based on NAS (scored by 0-1 for steatosis, 0-3 for inflammation, and 0-2 for ballooning)
and NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1
= centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 =
bridging fibrosis, 4 = cirrhosis)

A Study Evaluating Efruxifermin in Subjects with Compensated Cirrhosis Due to NASH/MASH

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?