A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NCT ID: NCT06215716
Last Updated: 2025-11-14
Study Results
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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RECRUITING
PHASE3
1650 participants
INTERVENTIONAL
2023-12-01
2032-11-30
Brief Summary
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The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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EFX 28 mg
Efruxifermin
Administered by subcutaneous injection
EFX 50 mg
Efruxifermin
Administered by subcutaneous injection
Placebo
Placebo
Administered by subcutaneous injection
Interventions
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Efruxifermin
Administered by subcutaneous injection
Placebo
Administered by subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.
* Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:
* Steatosis (scored 0 to 3),
* Ballooning degeneration (scored 0 to 2), and
* Lobular inflammation (scored 0 to 3).
Exclusion Criteria
* Presence of cirrhosis on liver biopsy (fibrosis stage 4).
* Type 1 or uncontrolled Type 2 diabetes.
18 Years
80 Years
ALL
No
Sponsors
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Akero Therapeutics, Inc
INDUSTRY
Responsible Party
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Locations
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Akero Clinical Study Site
Birmingham, Alabama, United States
Akero Clinical Study Site
Dothan, Alabama, United States
Akero Clinical Study Site
Chandler, Arizona, United States
Akero Clinical Study Site
Flagstaff, Arizona, United States
Akero Clinical Study Site
Mesa, Arizona, United States
Akero Clinical Study Site
Peoria, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Conway, Arkansas, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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North Little Rock, Arkansas, United States
Akero Clinical Study Site
Chula Vista, California, United States
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Coronado, California, United States
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Escondido, California, United States
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Folsom, California, United States
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Inglewood, California, United States
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La Mesa, California, United States
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Lancaster, California, United States
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Lancaster, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Orange, California, United States
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Palm Springs, California, United States
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Pasadena, California, United States
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Redwood City, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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San Francisco, California, United States
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Santa Maria, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Englewood, Colorado, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Bradenton, Florida, United States
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Brandon, Florida, United States
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Doral, Florida, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Hialeah Gardens, Florida, United States
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Inverness, Florida, United States
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Jacksonville, Florida, United States
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Lady Lake, Florida, United States
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Lakewood Rch, Florida, United States
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Largo, Florida, United States
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Lehigh Acres, Florida, United States
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Maitland, Florida, United States
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Margate, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Gardens, Florida, United States
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Miami Lakes, Florida, United States
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Naples, Florida, United States
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New Port Richey, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Port Orange, Florida, United States
Clinical Study Site
Riverview, Florida, United States
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Sarasota, Florida, United States
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Temple Terrace, Florida, United States
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Venice, Florida, United States
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Viera, Florida, United States
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West Palm Beach, Florida, United States
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Winter Park, Florida, United States
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Winter Park, Florida, United States
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Zephyrhills, Florida, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Gainesville, Georgia, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Hammond, Indiana, United States
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South Bend, Indiana, United States
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West Des Moines, Iowa, United States
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Topeka, Kansas, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Bastrop, Louisiana, United States
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Covington, Louisiana, United States
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Houma, Louisiana, United States
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Marrero, Louisiana, United States
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Marrero, Louisiana, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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West Monroe, Louisiana, United States
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Baltimore, Maryland, United States
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Glen Burnie, Maryland, United States
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Greenbelt, Maryland, United States
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South Dartmouth, Massachusetts, United States
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Novi, Michigan, United States
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Southfield, Michigan, United States
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Wyoming, Michigan, United States
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Ypsilanti, Michigan, United States
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Flowood, Mississippi, United States
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Columbia, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Florham Park, New Jersey, United States
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Ridgewood, New Jersey, United States
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Somers Point, New Jersey, United States
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Sparta, New Jersey, United States
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Santa Fe, New Mexico, United States
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Buffalo, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Fayetteville, North Carolina, United States
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Morehead City, North Carolina, United States
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New Bern, North Carolina, United States
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Raleigh, North Carolina, United States
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Statesville, North Carolina, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Springboro, Ohio, United States
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Westlake, Ohio, United States
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Medford, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Summerville, South Carolina, United States
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Chattanooga, Tennessee, United States
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Clarksville, Tennessee, United States
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Hermitage, Tennessee, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Bellaire, Texas, United States
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Brownsville, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Denison, Texas, United States
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Edinburg, Texas, United States
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Edinburg, Texas, United States
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Forney, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Lewisville, Texas, United States
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McAllen, Texas, United States
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Pasadena, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Marcos, Texas, United States
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San Marcos, Texas, United States
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Waco, Texas, United States
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Waco, Texas, United States
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Webster, Texas, United States
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Wichita Falls, Texas, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Sandy City, Utah, United States
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South Ogden, Utah, United States
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Falls Church, Virginia, United States
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Newport News, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Roanoke, Virginia, United States
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Suffolk, Virginia, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
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La Plata, Buenos Aires, Argentina
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Ramos Mejía, Buenos Aires, Argentina
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Buenos Aires, Distrito Federal, Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Broadmeadow, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Liverpool, New South Wales, Australia
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Westmead, New South Wales, Australia
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Adelaide, South Australia, Australia
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Caulfield South, Victoria, Australia
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Epping, Victoria, Australia
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Frankston, Victoria, Australia
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Heidelberg, Victoria, Australia
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Melbourne, Victoria, Australia
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Murdoch, Western Australia, Australia
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Nedlands, Western Australia, Australia
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Perth, Western Australia, Australia
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Edmonton, Alberta, Canada
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Hamilton, Ontario, Canada
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Toronto, Ontario, Canada
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Vaughan, Ontario, Canada
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Montreal, Quebec, Canada
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Terrebonne, Quebec, Canada
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Nice, Alpes-Maritimes, France
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Lyon, Auvergne-Rhône-Alpes, France
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Strasbourg, Bas-Rhin, France
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Limoges, Haute-Vienne, France
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Clichy, Hauts-de-Seine, France
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Vandœuvre-lès-Nancy, Lorraine, France
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Angers, Maine-et-Loire, France
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Toulouse, Occitanie, France
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Marseille, Provence-Alpes-Côte d'Azur Region, France
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Montpellier Cedex 5, Provence-Alpes-Côte d'Azur Region, France
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Versailles, Yvelines, Île-de-France, France
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Paris, Île-de-France Region, France
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Würzburg, Bavaria, Germany
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Frankfurt am Main, Hesse, Germany
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Mainz, Rhineland-Palatinate, Germany
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Leipzig, Saxony, Germany
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Leipzig, Saxony, Germany
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Leipzig, Saxony, Germany
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Lübeck, Schleswig-Holstein, Germany
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Berlin, , Germany
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Berlin, , Germany
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Surat, Gujarat, India
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Vadodara, Gujarat, India
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Thiruvananthapuram, Kerala, India
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Dahegaon, Maharashtra, India
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Nagpur, Maharashtra, India
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Pune, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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New Delhi, National Capital Territory of Delhi, India
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Jaipur, Rajasthan, India
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Jaipur, Rajasthan, India
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Coimbatore, Tamil Nadu, India
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Hyderabad, Telangana, India
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Varanasi, Uttar Pradesh, India
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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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Haifa, Haifa District, Israel
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Haifa, Haifa District, Israel
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Afula, Northern District, Israel
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Nahariya, Northern District, Israel
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Nazareth, Northern District, Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Tel Aviv, , Israel
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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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Foggia, , Italy
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Messina, , Italy
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Milan, , Italy
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Milan, , Italy
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Modena, , Italy
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Napoli, , Italy
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Novara, , Italy
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Cuauhtémoc, Mexico City, 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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Warsaw, Masovian Voivodeship, Poland
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Warsaw, Masovian Voivodeship, Poland
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Gdansk, Pomeranian Voivodeship, Poland
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Gdynia, Pomeranian Voivodeship, Poland
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Częstochowa, Silesian Voivodeship, Poland
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Katowice, Silesian Voivodeship, Poland
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Katowice, Silesian Voivodeship, Poland
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Lodz, Łódź 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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Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi], South Korea
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Goyang-si, Gyeonggi-do, South Korea
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Incheon, Gyeonggi-do, South Korea
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Seongnam-si, Gyeonggi-do, South Korea
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Seongnam-si, Gyeonggido [Kyonggi-do], South Korea
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Daegu, Gyeongsangbugdo [Kyongsangbuk-do], South Korea
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Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea
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Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea
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Sabadell, Barcelona, Spain
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Santander, Cantabria, Spain
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Majadahonda, Madrid, Spain
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Valencia, València, Spain
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Valencia, València, Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Seville, , Spain
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Olten, Canton of Solothurn, Switzerland
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Bern, , Switzerland
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Sankt Gallen, , Switzerland
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Changhua, Changhua, Taiwan
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Taichung, Taichung, Taiwan
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Tainan, Tainan, Taiwan
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Taipei City, Taipei, Taiwan
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Kaohsiung City, , Taiwan
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Tainan, , Taiwan
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Taoyuan District, , Taiwan
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Yenimahalle, Ankara, Turkey (Türkiye)
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Bornova, İzmir, Turkey (Türkiye)
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Bursa, , Turkey (Türkiye)
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Rize, , Turkey (Türkiye)
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Birmingham, England, United Kingdom
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Cambridge, England, United Kingdom
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Liverpool, England, United Kingdom
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London, England, United Kingdom
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London, England, United Kingdom
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London, England, United Kingdom
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London, England, United Kingdom
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London, England, United Kingdom
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Newcastle upon Tyne, England, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Akero Site 0129
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AK-US-001-0105
Identifier Type: -
Identifier Source: org_study_id