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NCT06528314 | RECRUITING | NASH - Nonalcoholic Steatohepatitis

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

Condition or disease

NASH - Nonalcoholic Steatohepatitis

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Intervention/treatment

Efruxifermin

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 1150 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2024-06-10
Estimated Primary Completion Date : 2029-09
Estimated Study Completion Date : 2029-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
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
A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

Location Details

NCT06528314

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Alabama

Akero Clinical Study Site

Birmingham, Alabama, United States, 35209

RECRUITING

United States, Arizona

Akero Clinical Study Site

Tucson, arizona, United States, 85712

RECRUITING

United States, Arizona

Akero Clinical Study Site

Tucson, arizona, United States, 85715

RECRUITING

United States, Arkansas

Akero Clinical Study Site

North Little Rock, arkansas, United States, 72117

RECRUITING

United States, California

Akero Clinical Study Site

Pasadena, California, United States, 91105

RECRUITING

United States, Florida

Akero Clinical Study Site

Hialeah Gardens, Florida, United States, 33016

RECRUITING

United States, Florida

Akero Clinical Study Site

Lakewood Ranch, Florida, United States, 34211

RECRUITING

United States, Florida

Akero Clinical Study Site

Naples, Florida, United States, 34102

RECRUITING

United States, Florida

Akero Clinical Study Site

Ocala, Florida, United States, 34471

RECRUITING

United States, Florida

Akero Clinical Study Site

Venice, Florida, United States, 34285

RECRUITING

United States, Georgia

Akero Clinical Study Site

Gainesville, Georgia, United States, 30501

RECRUITING

United States, Georgia

Akero Clinical Study Site

Marietta, Georgia, United States, 30060

RECRUITING

United States, Indiana

Akero Clinical Study Site

South Bend, Indiana, United States, 46635

RECRUITING

United States, Kansas

Akero Clinical Study Site

Topeka, Kansas, United States, 66606

RECRUITING

United States, Louisiana

Akero Clinical Study Site

Covington, Louisiana, United States, 70433

RECRUITING

United States, Louisiana

Akero Clinical Study Site

Houma, Louisiana, United States, 70363

RECRUITING

United States, Louisiana

Akero Clinical Study Site

Marrero, Louisiana, United States, 70072

RECRUITING

United States, Louisiana

Akero Clinical Study Site

Metairie, Louisiana, United States, 70006

RECRUITING

United States, Louisiana

Akero Clinical Study Site

Shreveport, Louisiana, United States, 71105

RECRUITING

United States, Maryland

Akero Clinical Study Site

Baltimore, Maryland, United States, 21202

RECRUITING

United States, Missouri

Akero Clinical Study Site

Columbia, Missouri, United States, 65201

RECRUITING

United States, Missouri

Akero Clinical Study Site

Kansas City, Missouri, United States, 64131

RECRUITING

United States, Nevada

Akero Clinical Study Site

vegas, Nevada, United States, 89106

RECRUITING

United States, New Jersey

Akero Clinical Study Site

Sparta, New Jersey, United States, 07871

RECRUITING

United States, North Carolina

Akero Clinical Study Site

Statesville, North Carolina, United States, 28625

RECRUITING

United States, Ohio

Akero Clinical Study Site

Springboro, Ohio, United States, 45066

RECRUITING

United States, Ohio

Akero Clinical Study Site

Westlake, Ohio, United States, 44145

RECRUITING

United States, South Carolina

Akero Clinical Study Site

Columbia, South Carolina, United States, 29204

RECRUITING

United States, Tennessee

Akero Clinical Study Site

Hermitage, Tennessee, United States, 37076

RECRUITING

United States, Texas

Akero Clinical Study Site

Austin, Texas, United States, 78745

RECRUITING

United States, Texas

Akero Clinical Study Site

Austin, Texas, United States, 78757

RECRUITING

United States, Texas

Akero Clinical Study Site

Brownsville, Texas, United States, 78520

RECRUITING

United States, Texas

Akero Clinical Study Site

dallas, Texas, United States, 75234

RECRUITING

United States, Texas

Akero Clinical Study Site

Edinburg, Texas, United States, 78539

RECRUITING

United States, Texas

Akero Clinical Study Site

Saint Anthony, Texas, United States, 78222

RECRUITING

United States, Texas

Akero Clinical Study Site

Saint Anthony, Texas, United States, 78229

RECRUITING

United States, Texas

Akero Clinical Study Site

Wichita Falls, Texas, United States, 76301

RECRUITING

United States, Virginia

Akero Clinical Study Site

Richmond, Virginia, United States, 23236

RECRUITING

United States, Virginia

Akero Clinical Study Site

Roanoke, Virginia, United States, 24014

RECRUITING

Puerto Rico,

Akero Clinical Study Site

Saint John, Puerto Rico, 00927