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

Phase 3

Recruiting

• Conditions: NASH - Nonalcoholic Steatohepatitis; MASH - Metabolic Dysfunction-Associated Steatohepatitis
• Interventions: Drug: Efruxifermin; Drug: Placebo

• Registration Number: NCT06528314
• Lead Sponsor: Akero Therapeutics, Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-07-25
• Study First Posted: 2024-07-30
• Study Start: 2024-09-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06
• Primary Completion: 2029-09
• Study Completion: 2029-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1150

Inclusion Criteria

• Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
• Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH

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Exclusion Criteria

• Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results
• Type 1 diabetes or unstable Type 2 diabetes
• Any current or prior history of decompensated liver disease

Other inclusion and exclusion criteria may apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EFX 50 mg	Efruxifermin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Time from randomization to first occurrence of disease progression as measured by composite of protocol-specified clinical events	5 years
Cohort 1 only: ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis	96 Weeks	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)

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of EFX through the reporting of extent of exposure (weeks)	96 Weeks
Number of participants with abnormal laboratory tests results, abnormal ECGs, abnormal ultrasounds, abnormal vital sign assessments	96 Weeks
Cohort 1 only: ≥ 1 stage improvement in fibrosis	96 Weeks, 5 Years	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)
Change from baseline of non-invasive markers of liver fibrosis	96 Weeks	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)
Change from baseline of markers of liver injury	96 Weeks	ALT (U/L) and AST (U/L)
Change from baseline of lipoproteins	96 Weeks	Total cholesterol (mg/dL), Triglycerides (mg/dL), HDL-C (mg/dL), Non-HDL-C (mg/dL), and LDL-C (mg/dL)
Change from baseline of markers of insulin sensitivity and glycemic control	96 Weeks	HOMA-IR (≥ 2.5 indicates insulin resistance)
Change from baseline of body weight (kg)	96 Weeks
To assess the safety and tolerability of EFX through the reporting of adverse events (severity of events)	96 Weeks
Cohort 1 only: ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis	5 Years	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)
Cohort 1 only: Resolution of NASH/MASH	96 Weeks, 5 Years	Based on NAS (scored by 0-1 for steatosis, 0-3 for inflammation, and 0-2 for ballooning)
Cohort 1 only: Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis	96 Weeks, 5 Years	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)
To assess the safety and tolerability of EFX through the reporting of adverse events (frequency of events)	96 Weeks

Trial Locations

Locations (1)

Akero Clinical Study Site; 🇪🇸 Santander, Cantabria, Spain