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

NCT ID: NCT06528314

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-04

Study Completion Date

2029-10-31

Brief Summary

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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

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Conditions

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NASH - Nonalcoholic Steatohepatitis MASH - Metabolic Dysfunction-Associated Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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EFX 50 mg

Group Type EXPERIMENTAL

Efruxifermin

Intervention Type DRUG

Administered by subcutaneous injection

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered by subcutaneous injection

Interventions

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Efruxifermin

Administered by subcutaneous injection

Intervention Type DRUG

Placebo

Administered by subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akero Therapeutics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Akero Clinical Study Site

Birmingham, Alabama, United States

Site Status RECRUITING

Akero Clinical Study Site

Dothan, Alabama, United States

Site Status RECRUITING

Akero Clinical Study Site

Chandler, Arizona, United States

Site Status RECRUITING

Akero Clinical Study Site

Flagstaff, Arizona, United States

Site Status ACTIVE_NOT_RECRUITING

Akero Clinical Study Site

Peoria, Arizona, United States

Site Status RECRUITING

Akero Clinical Study Site

Scottsdale, Arizona, United States

Site Status RECRUITING

Akero Clinical Study Site

Tucson, Arizona, United States

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Akero Clinical Study Site

Tucson, Arizona, United States

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Akero Clinical Study Site

Tucson, Arizona, United States

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Akero Clinical Study Site

Tucson, Arizona, United States

Site Status RECRUITING

Akero Clinical Study Site

Conway, Arkansas, United States

Site Status RECRUITING

Akero Clinical Study Site

Jonesboro, Arkansas, United States

Site Status ACTIVE_NOT_RECRUITING

Akero Clinical Study Site

Little Rock, Arkansas, United States

Site Status RECRUITING

Akero Clinical Study Site

North Little Rock, Arkansas, United States

Site Status RECRUITING

Akero Clinical Study Site

Coronado, California, United States

Site Status RECRUITING

Akero Clinical Study Site

Escondido, California, United States

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Akero Clinical Study Site

Folsom, California, United States

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Akero Clinical Study Site

Lancaster, California, United States

Site Status RECRUITING

Akero Clinical Study Site

Long Beach, California, United States

Site Status RECRUITING

Akero Clinical Study Site

Los Angeles, California, United States

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Akero Clinical Study Site

Newport Beach, California, United States

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Akero Clinical Study Site

Orange, California, United States

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Akero Clinical Study Site

Pasadena, California, United States

Site Status RECRUITING

Akero Clinical Study Site

Redwood City, California, United States

Site Status RECRUITING

Akero Clinical Study Site

San Francisco, California, United States

Site Status RECRUITING

Akero Clinical Study Site

San Francisco, California, United States

Site Status ACTIVE_NOT_RECRUITING

Akero Clinical Study Site

San Jose, California, United States

Site Status RECRUITING

Akero Clinical Study Site

Aurora, Colorado, United States

Site Status RECRUITING

Akero Clinical Study Site

Colorado Springs, Colorado, United States

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Akero Clinical Study Site

Englewood, Colorado, United States

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Akero Clinical Study Site

New Haven, Connecticut, United States

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Akero Clinical Study Site

Washington D.C., District of Columbia, United States

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Akero Clinical Study Site

Bradenton, Florida, United States

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Akero Clinical Study Site

Brandon, Florida, United States

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Akero Clinical Study Site

Cutler Bay, Florida, United States

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Akero Clinical Study Site

Doral, Florida, United States

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Akero Clinical Study Site

Fort Myers, Florida, United States

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Akero Clinical Study Site

Hialeah Gardens, Florida, United States

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Akero Clinical Study Site

Inverness, Florida, United States

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Akero Clinical Study Site

Lakewood Rch, Florida, United States

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Akero Clinical Study Site

Largo, Florida, United States

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Akero Clinical Study Site

Lehigh Acres, Florida, United States

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Akero Clinical Study Site

Margate, Florida, United States

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Akero Clinical Study Site

Miami, Florida, United States

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Akero Clinical Study Site

Miami, Florida, United States

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Akero Clinical Study Site

Miami Gardens, Florida, United States

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Akero Clinical Study Site

Naples, Florida, United States

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Akero Clinical Study Site

New Port Richey, Florida, United States

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Akero Clinical Study Site

Ocala, Florida, United States

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Akero Clinical Study Site

Orlando, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Akero Clinical Study Site

Orlando, Florida, United States

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Akero Clinical Study Site

Pembroke Pines, Florida, United States

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Akero Clinical Study Site

Riverview, Florida, United States

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Akero Clinical Study Site

Sarasota, Florida, United States

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Akero Clinical Study Site

Temple Terrace, Florida, United States

Site Status RECRUITING

Akero Clinical Study Site

Venice, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Akero Clinical Study Site

Weston, Florida, United States

Site Status RECRUITING

Akero Clinical Study Site

Zephyrhills, Florida, United States

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Akero Clinical Study Site

Atlanta, Georgia, United States

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Akero Clinical Study Site

Gainesville, Georgia, United States

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Akero Clinical Study Site

Marietta, Georgia, United States

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Akero Clinical Study Site

Snellville, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

Akero Clinical Study Site

Chicago, Illinois, United States

Site Status RECRUITING

Akero Clinical Study Site

Hammond, Indiana, United States

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Akero Clinical Study Site

Indianapolis, Indiana, United States

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Akero Clinical Study Site

South Bend, Indiana, United States

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Akero Clinical Study Site

West Des Moines, Iowa, United States

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Akero Clinical Study Site

Topeka, Kansas, United States

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Akero Clinical Study Site

Louisville, Kentucky, United States

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Akero Clinical Study Site

Bastrop, Louisiana, United States

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Akero Clinical Study Site

Covington, Louisiana, United States

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Akero Clinical Study Site

Houma, Louisiana, United States

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Akero Clinical Study Site

Lafayette, Louisiana, United States

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Akero Clinical Study Site

Marrero, Louisiana, United States

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Akero Clinical Study Site

Metairie, Louisiana, United States

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Akero Clinical Study Site

Shreveport, Louisiana, United States

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Akero Clinical Study Site

West Monroe, Louisiana, United States

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Akero Clinical Study Site

Baltimore, Maryland, United States

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Akero Clinical Study Site

Bethesda, Maryland, United States

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Akero Clinical Study Site

South Dartmouth, Massachusetts, United States

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Akero Clinical Study Site

Clinton Township, Michigan, United States

Site Status ACTIVE_NOT_RECRUITING

Akero Clinical Study Site

Novi, Michigan, United States

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Akero Clinical Study Site

Southfield, Michigan, United States

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Akero Clinical Study Site

Rochester, Minnesota, United States

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Akero Clinical Study Site

Flowood, Mississippi, United States

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Akero Clinical Study Site

Columbia, Missouri, United States

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Akero Clinical Study Site

Kansas City, Missouri, United States

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Akero Clinical Study Site

St Louis, Missouri, United States

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Akero Clinical Study Site

St Louis, Missouri, United States

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Akero Clinical Study Site

Las Vegas, Nevada, United States

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Akero Clinical Study Site

Jackson, New Jersey, United States

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Akero Clinical Study Site

Somers Point, New Jersey, United States

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Akero Clinical Study Site

Sparta, New Jersey, United States

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Akero Clinical Study Site

Buffalo, New York, United States

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Akero Clinical Study Site

Manhasset, New York, United States

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Akero Clinical Study Site

New York, New York, United States

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Akero Clinical Study Site

New York, New York, United States

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Akero Clinical Study Site

New York, New York, United States

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Akero Clinical Study Site

Rochester, New York, United States

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Akero Clinical Study Site

Chapel Hill, North Carolina, United States

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Akero Clinical Study Site

Charlotte, North Carolina, United States

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Akero Clinical Study Site

Charlotte, North Carolina, United States

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Akero Clinical Study Site

Durham, North Carolina, United States

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Akero Clinical Study Site

Fayetteville, North Carolina, United States

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Akero Clinical Study Site

Morehead City, North Carolina, United States

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Akero Clinical Study Site

Raleigh, North Carolina, United States

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Akero Clinical Study Site

Statesville, North Carolina, United States

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Akero Clinical Study Site

Akron, Ohio, United States

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Akero Clinical Study Site

Springboro, Ohio, United States

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Akero Clinical Study Site

Westlake, Ohio, United States

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Akero Clinical Study Site

Hershey, Pennsylvania, United States

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Akero Clinical Study Site

Philadelphia, Pennsylvania, United States

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Akero Clinical Study Site

Philadelphia, Pennsylvania, United States

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Akero Clinical Study Site

Pittsburgh, Pennsylvania, United States

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Akero Clinical Study Site

Charleston, South Carolina, United States

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Akero Clinical Study Site

Columbia, South Carolina, United States

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Akero Clinical Study Site

Summerville, South Carolina, United States

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Akero Clinical Study Site

Clarksville, Tennessee, United States

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Akero Clinical Study Site

Hermitage, Tennessee, United States

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Akero Clinical Study Site

Nashville, Tennessee, United States

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Akero Clinical Study Site

Amarillo, Texas, United States

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Akero Clinical Study Site

Austin, Texas, United States

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Akero Clinical Study Site

Austin, Texas, United States

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Akero Clinical Study Site

Austin, Texas, United States

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Akero Clinical Study Site

Bellaire, Texas, United States

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Akero Clinical Study Site

Brownsville, Texas, United States

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Akero Clinical Study Site

Corpus Christi, Texas, United States

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Akero Clinical Study Site

Dallas, Texas, United States

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Akero Clinical Study Site

Dallas, Texas, United States

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Akero Clinical Study Site

Dallas, Texas, United States

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Akero Clinical Study Site

Dallas, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

Akero Clinical Study Site

Dallas, Texas, United States

Site Status RECRUITING

Akero Clinical Study Site

Denison, Texas, United States

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Akero Clinical Study Site

Edinburg, Texas, United States

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Akero Clinical Study Site

Edinburg, Texas, United States

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Akero Clinical Study Site

Fort Sam Houston, Texas, United States

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Akero Clinical Study Site

Fort Worth, Texas, United States

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Akero Clinical Study Site

Garland, Texas, United States

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Akero Clinical Study Site

Houston, Texas, United States

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Akero Clinical Study Site

Houston, Texas, United States

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Akero Clinical Study Site

Houston, Texas, United States

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Akero Clinical Study Site

Houston, Texas, United States

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Akero Clinical Study Site

Houston, Texas, United States

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Akero Clinical Study Site

Pasadena, Texas, United States

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Akero Clinical Study Site

Pharr, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

Akero Clinical Study Site

San Antonio, Texas, United States

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Akero Clinical Study Site

San Antonio, Texas, United States

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Akero Clinical Study Site

San Antonio, Texas, United States

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Akero Clinical Study Site

San Antonio, Texas, United States

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Akero Clinical Study Site

Sugar Land, Texas, United States

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Akero Clinical Study Site

Sugar Land, Texas, United States

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Akero Clinical Study Site

Waco, Texas, United States

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Akero Clinical Study Site

Waco, Texas, United States

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Akero Clinical Study Site

Webster, Texas, United States

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Akero Clinical Study Site

Wichita Falls, Texas, United States

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Akero Clinical Study Site

Norfolk, Virginia, United States

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Akero Clinical Study Site

Richmond, Virginia, United States

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Akero Clinical Study Site

Richmond, Virginia, United States

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Akero Clinical Study Site

Richmond, Virginia, United States

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Akero Clinical Study Site

Richmond, Virginia, United States

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Akero Clinical Study Site

Roanoke, Virginia, United States

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Akero Clinical Study Site

Seattle, Washington, United States

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Akero Clinical Study Site

Madison, Wisconsin, United States

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Akero Clinical Study Site

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

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Akero Clinical Study Site

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

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Akero Clinical Study Site

La Plata, Buenos Aires, Argentina

Site Status RECRUITING

Akero Clinical Study Site

Ramos Mejía, Buenos Aires, Argentina

Site Status RECRUITING

Akero Clinical Study Site

Buenos Aires, Distrito Federal, Argentina

Site Status ACTIVE_NOT_RECRUITING

Akero Clinical Study Site

Rosario, Sante Fe, Argentina

Site Status RECRUITING

Akero Clinical Study Site

Buenos Aires, , Argentina

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Akero Clinical Study Site

Broadmeadow, New South Wales, Australia

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Akero Clinical Study Site

Liverpool, New South Wales, Australia

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Akero Clinical Study Site

Westmead, New South Wales, Australia

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Akero Clinical Study Site

Herston, Queensland, Australia

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Akero Clinical Study Site

Adelaide, South Australia, Australia

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Akero Clinical Study Site

Box Hill, Victoria, Australia

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Akero Clinical Study Site

Clayton, Victoria, Australia

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Akero Clinical Study Site

Epping, Victoria, Australia

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Akero Clinical Study Site

Heidelberg, Victoria, Australia

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Akero Clinical Study Site

Melbourne, Victoria, Australia

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Akero Clinical Study Site

Murdoch, Western Australia, Australia

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Akero Clinical Study Site

Nedlands, Western Australia, Australia

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Akero Clinical Study Site

Perth, Western Australia, Australia

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Akero Clinical Study Site

Brasília, Federal District, Brazil

Site Status ACTIVE_NOT_RECRUITING

Akero Clinical Study Site

Goiânia, Goiás, Brazil

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Akero Clinical Study Site

Belo Horizonte, Minas Gerais, Brazil

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Akero Clinical Study Site

Porto Alegre, Rio Grande do Sul, Brazil

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Akero Clinical Study Site

Edmonton, Alberta, Canada

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Akero Clinical Study Site

Toronto, Ontario, Canada

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Akero Clinical Study Site

Vaughan, Ontario, Canada

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Akero Clinical Study Site

Montreal, Quebec, Canada

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Akero Clinical Study Site

Terrebonne, Quebec, Canada

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Akero Clinical Study Site

La Serena, Coquimbo Region, Chile

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Akero Clinical Study Site

Las Condes, Santiago Metropolitan, Chile

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Akero Clinical Study Site

Santiago, Santiago Metropolitan, Chile

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Akero Clinical Study Site

Santiago, Santiago Metropolitan, Chile

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Akero Clinical Study Site

Santiago, Santiago Metropolitan, Chile

Site Status ACTIVE_NOT_RECRUITING

Akero Clinical Study Site

Strasbourg, Bas-Rhin, France

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Akero Clinical Study Site

Limoges, Haute-Vienne, France

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Akero Clinical Study Site

Lille, Hauts-de-France, France

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Akero Clinical Study Site

Clichy, Hauts-de-Seine, France

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Akero Clinical Study Site

Vandœuvre-lès-Nancy, Lorraine, France

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Akero Clinical Study Site

Angers, Maine-et-Loire, France

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Akero Clinical Study Site

Toulouse, Occitanie, France

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Akero Clinical Study Site

Marseille, Provence-Alpes-Côte d'Azur Region, France

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Akero Clinical Study Site

Montpellier Cedex 5, Provence-Alpes-Côte d'Azur Region, France

Site Status RECRUITING

Akero Clinical Study Site

Nice, Provence-Alpes-Côte d'Azur Region, France

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Akero Clinical Study Site

Lyon, Rhône, France

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Akero Clinical Study Site

Créteil, Val-de-Marne, France

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Akero Clinical Study Site

Le Chesnay, Île-de-France Region, France

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Akero Clinical Study Site

Paris, Île-de-France Region, France

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Akero Clinical Study Site

Frankfurt am Main, Hesse, Germany

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Akero Clinical Study Site

Homburg, Saarland, Germany

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Akero Clinical Study Site

Leipzig, Saxony, Germany

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Akero Clinical Study Site

Leipzig, Saxony, Germany

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Akero Clinical Study Site

Lübeck, Schleswig-Holstein, Germany

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Akero Clinical Study Site

Berlin, , Germany

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Akero Clinical Study Site

Hyderabad, Andhra Pradesh, India

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Akero Clinical Study Site

Surat, Gujarat, India

Site Status ACTIVE_NOT_RECRUITING

Akero Clinical Study Site

Surat, Gujarat, India

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Akero Clinical Study Site

Vadodara, Gujarat, India

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Akero Clinical Study Site

Mysore, Karnataka, India

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Akero Clinical Study Site

Thiruvananthapuram, Kerala, India

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Akero Clinical Study Site

Mumbai, Maharashtra, India

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Akero Clinical Study Site

Mumbai, Maharashtra, India

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Akero Clinical Study Site

Nagpur, Maharashtra, India

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Akero Clinical Study Site

Pune, Maharashtra, India

Site Status ACTIVE_NOT_RECRUITING

Akero Clinical Study Site

New Delhi, National Capital Territory of Delhi, India

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Akero Clinical Study Site

New Delhi, National Capital Territory of Delhi, India

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Akero Clinical Study Site

New Delhi, National Capital Territory of Delhi, India

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Akero Clinical Study Site

Chandigarh, Punjab, India

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Akero Clinical Study Site

Ludhiana, Punjab, India

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Akero Clinical Study Site

Jaipur, Rajasthan, India

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Jaipur, Rajasthan, India

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Akero Clinical Study Site

Coimbatore, Tamil Nadu, India

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Akero Clinical Study Site

Hyderabad, Telangana, India

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Varanasi, Uttar Pradesh, India

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Varanasi, Uttar Pradesh, India

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Rishikesh, Uttarakhand, India

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Akero Clinical Study Site

Kolkata, West Bengal, India

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Kolkata, West Bengal, India

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Kolkata, West Bengal, India

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Petah Tikva, Central District, Israel

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Ramat Gan, Central District, Israel

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Akero Clinical Study Site

Haifa, Haifa District, Israel

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Akero Clinical Study Site

Afula, Northern District, Israel

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Akero Clinical Study Site

Nahariya, Northern District, Israel

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Haifa, , Israel

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Akero Clinical Study Site

Jerusalem, , Israel

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Akero Clinical Study Site

Jerusalem, , Israel

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Akero Clinical Study Site

Tel Aviv, , Israel

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Akero Clinical Study Site

Tel Aviv, , Israel

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Akero Clinical Study Site

Foggia, Apulia, Italy

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Akero Clinical Study Site

San Giovanni Rotondo, Foggia, Italy

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Rozzano, Milan, Italy

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Torino, Turin, Italy

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Bologna, , Italy

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Messina, , Italy

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Akero Clinical Study Site

Milan, , Italy

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Akero Clinical Study Site

Milan, , Italy

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Akero Clinical Study Site

Modena, , Italy

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Akero Clinical Study Site

Novara, , Italy

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Akero Clinical Study Site

Guadalajara, Jalisco, Mexico

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Akero Clinical Study Site

Cuauhtémoc, Mexico City, Mexico

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Akero Clinical Study Site

Mexico City, Mexico City, Mexico

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Mérida, Yucatán, Mexico

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Benito Juárez, , Mexico

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Poznan, Greater Poland Voivodeship, Poland

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Krakow, Lesser Poland Voivodeship, Poland

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Wroclaw, Lower Silesian Voivodeship, Poland

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Wroclaw, Lower Silesian Voivodeship, Poland

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Lodz, Lódzkie, Poland

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Warsaw, Masovian Voivodeship, Poland

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Warsaw, Masovian Voivodeship, Poland

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Częstochowa, Silesian Voivodeship, Poland

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Katowice, Silesian Voivodeship, Poland

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Manatí, , Puerto Rico

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Mayagüez, , Puerto Rico

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San Juan, , Puerto Rico

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Akero Clinical Study Site

Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi], South Korea

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Incheon, Gyeonggi-do, South Korea

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Akero Clinical Study Site

Goyang-si, Gyeonggido, South Korea

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Akero Clinical Study Site

Daegu, Gyeongsangbugdo [Kyongsangbuk-do], South Korea

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Akero Clinical Study Site

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea

Site Status RECRUITING

Akero Clinical Study Site

Seoul, Seoul Teugbyeolsi, South Korea

Site Status RECRUITING

Akero Clinical Study Site

Sabadell, Barcelona, Spain

Site Status RECRUITING

Akero Clinical Study Site

Santander, Cantabria, Spain

Site Status RECRUITING

Akero Clinical Study Site

Majadahonda, Madrid, Spain

Site Status RECRUITING

Akero Clinical Study Site

Barcelona, , Spain

Site Status RECRUITING

Akero Clinical Study Site

Madrid, , Spain

Site Status RECRUITING

Akero Clinical Study Site

Madrid, , Spain

Site Status RECRUITING

Akero Clinical Study Site

Seville, , Spain

Site Status RECRUITING

Akero Clinical Study Site

Valencia, , Spain

Site Status RECRUITING

Akero Clinical Study Site

Valencia, , Spain

Site Status RECRUITING

Akero Clinical Study Site

Lugano, Canton Ticino, Switzerland

Site Status RECRUITING

Akero Clinical Study Site

Bern, , Switzerland

Site Status RECRUITING

Akero Clinical Study Site

Sankt Gallen, , Switzerland

Site Status RECRUITING

Akero Clinical Study Site

Zurich, , Switzerland

Site Status RECRUITING

Akero Clinical Study Site

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Akero Clinical Study Site

Bursa, , Turkey (Türkiye)

Site Status RECRUITING

Akero Clinical Study Site

Rize, , Turkey (Türkiye)

Site Status RECRUITING

Akero Clinical Study Site

London, England, United Kingdom

Site Status RECRUITING

Akero Clinical Study Site

Nottingham, England, United Kingdom

Site Status RECRUITING

Akero Clinical Study Site

Birmingham, , United Kingdom

Site Status RECRUITING

Akero Clinical Study Site

London, , United Kingdom

Site Status RECRUITING

Akero Clinical Study Site

London, , United Kingdom

Site Status RECRUITING

Akero Clinical Study Site

Newcastle upon Tyne, , United Kingdom

Site Status RECRUITING

Akero Clinical Study Site

Whitechapel, , United Kingdom

Site Status RECRUITING

Countries

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United States Argentina Australia Brazil Canada Chile France Germany India Israel Italy Mexico Poland Puerto Rico South Korea Spain Switzerland Turkey (Türkiye) United Kingdom

Central Contacts

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Akero Study Director

Role: CONTACT

650-487-6488

Facility Contacts

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Akero Site 0129

Role: primary

Akero Site 0233

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Akero Site 9106

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Akero Site 1809

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Other Identifiers

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AK-US-001-0106

Identifier Type: -

Identifier Source: org_study_id

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