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

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a study on Nonalcoholic Steatohepatitis Steatohepatitis Cirrhosis Liver Disease Nonalcoholic Fatty Liver Disease

Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Bilal Hameed (ucsf)
Headshot of Bilal Hameed
Bilal Hameed

Description

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.

Official Title

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

Keywords

NASH - Nonalcoholic Steatohepatitis, MASH - Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease, Efruxifermin, EFX 50 mg

Eligibility

You can join if…

Open to people ages 18-80

  • Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH and NAS score of >=3 (at least 1 in each category) or evidence of steatosis and 2 current features of metabolic comorbidities
  • Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH

You CAN'T join if...

  • 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.

Locations

  • Akero Clinical Study Site accepting new patients
    San Francisco California 94115 United States
  • Akero Clinical Study Site accepting new patients
    San Francisco California 94117 United States
  • Akero Clinical Study Site accepting new patients
    Los Angeles California 90048 United States
  • Akero Clinical Study Site accepting new patients
    Newport Beach California 92663 United States
  • Akero Clinical Study Site accepting new patients
    Fountain Valley California 92708 United States
  • Akero Clinical Study Site accepting new patients
    Tarzana California 91356 United States
  • Akero Clinical Study Site accepting new patients
    Los Angeles California 90015 United States
  • Akero Clinical Study Site accepting new patients
    Orange California 92868 United States
  • Akero Clinical Study Site accepting new patients
    Coronado California 92118 United States
  • Akero Clinical Study Site accepting new patients
    Pasadena California 91105 United States

Lead Scientist at University of California Health

  • Bilal Hameed (ucsf)
    I am a Professor of Medicine and Ambulatory Director of Hepatology. I was the program director for transplant hepatology fellowship. Beside busy clinically my research interest includes nonalcoholic steatohepatitis, PSC, ALF, HCC and cirrhosis. I am the co-PI for NIH funded Liver Cirrhosis Network (LCN) and site-PI for NIH funded NASH-CRN. I am the PI for many clinical trials in NASH and PSC.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Akero Therapeutics, Inc
ID
NCT06528314
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 2150 study participants
Last Updated
Contact us about this trial