Recruiting
Phase 3

Efruxifermin

Sponsor:

Akero Therapeutics, Inc

Code:

NCT06215716

Conditions

NASH With Fibrosis

MASH With Fibrosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Efruxifermin

Placebo

Study Details

Brief summary:

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3).

The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.

Conditions

NASH With Fibrosis

MASH With Fibrosis

Study ID

NCT06215716

Start date

Dec 1, 2023

Status verified date

Aug, 2026

Completion date

Feb, 2033

Anticipated

Primary completion date

Feb, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.
  • 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).
  • Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. Subjects with NAS <4 may be enrolled and are not required to meet 1 point in each of the components of NAS.

Exclusion Criteria:

  • Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results.
  • Presence of cirrhosis on liver biopsy (fibrosis stage 4).
  • Type 1 or uncontrolled Type 2 diabetes.

Other inclusion and exclusion criteria may apply.

Study Design

Enrollment

1650 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: EFX 28 mg

experimental: EFX 50 mg

placebo comparator: Placebo

Interventions

Efruxifermin

Administered by subcutaneous injection

Placebo

Administered by subcutaneous injection

Primary outcome measure

  • Cohort 1 Only: Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis [ Time Frame: 52 Weeks ]
  • Event-free survival [ Time Frame: 240 Weeks ]

Central Contacts and Locations

Central contacts

Locations

Akero Clinical Study Site

Recruiting

Birmingham, Alabama, United States, 35209

Akero Clinical Study Site

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Dothan, Alabama, United States, 36301

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Chandler, Arizona, United States, 85224

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Peoria, Arizona, United States, 85381

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Tucson, Arizona, United States, 85712

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Tucson, Arizona, United States, 85712

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Tucson, Arizona, United States, 85713

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Tucson, Arizona, United States, 85715

Akero Clinical Study Site

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Little Rock, Arkansas, United States, 72205

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North Little Rock, Arkansas, United States, 72117

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Coronado, California, United States, 92118

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Escondido, California, United States, 92025

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Folsom, California, United States, 95630

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Inglewood, California, United States, 90301

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Lancaster, California, United States, 93534

Akero Clinical Study Site

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Long Beach, California, United States, 90815

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Los Angeles, California, United States, 90048

Akero Clinical Study Site

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Los Angeles, California, United States, 90057

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Newport Beach, California, United States, 92663

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Orange, California, United States, 92868

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Palm Springs, California, United States, 92262

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Pasadena, California, United States, 91105

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Redwood City, California, United States, 94063

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Sacramento, California, United States, 95817

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San Diego, California, United States, 92120

Akero Clinical Study Site

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San Diego, California, United States, 92161

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San Francisco, California, United States, 94115

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San Francisco, California, United States, 94117

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Santa Maria, California, United States, 93458

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Aurora, Colorado, United States, 80045

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Colorado Springs, Colorado, United States, 80907

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Englewood, Colorado, United States, 80113

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New Haven, Connecticut, United States, 06520

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Washington D.C., District of Columbia, United States, 20422

Akero Clinical Study Site

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Bradenton, Florida, United States, 34208

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Brandon, Florida, United States, 33511

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Doral, Florida, United States, 33126

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Fort Myers, Florida, United States, 33912

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Gainesville, Florida, United States, 32610

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Hialeah Gardens, Florida, United States, 33016

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Inverness, Florida, United States, 34452

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Jacksonville, Florida, United States, 32256

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Lakewood Rch, Florida, United States, 34211

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Largo, Florida, United States, 33777

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Lehigh Acres, Florida, United States, 33936

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Margate, Florida, United States, 33063

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Miami, Florida, United States, 33136

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Miami, Florida, United States, 33175

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Miami Gardens, Florida, United States, 33014

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Miami Lakes, Florida, United States, 33016

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Naples, Florida, United States, 34102

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Ocala, Florida, United States, 34471

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Orlando, Florida, United States, 32807

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Pembroke Pines, Florida, United States, 33027

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Port Orange, Florida, United States, 32127

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Riverview, Florida, United States, 33578

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Sarasota, Florida, United States, 34240

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Temple Terrace, Florida, United States, 33617

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Weston, Florida, United States, 33331

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Winter Park, Florida, United States, 32789

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Winter Park, Florida, United States, 32792

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Zephyrhills, Florida, United States, 33542

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Atlanta, Georgia, United States, 30309

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Columbus, Georgia, United States, 31904

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Gainesville, Georgia, United States, 30501

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Marietta, Georgia, United States, 30060

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Chicago, Illinois, United States, 60637

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Hammond, Indiana, United States, 46324

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Indianapolis, Indiana, United States, 46202

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South Bend, Indiana, United States, 46635

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West Des Moines, Iowa, United States, 50265

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Topeka, Kansas, United States, 66606

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Louisville, Kentucky, United States, 40202

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Bastrop, Louisiana, United States, 71220

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Covington, Louisiana, United States, 70433

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Houma, Louisiana, United States, 70363

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Marrero, Louisiana, United States, 70072

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Metairie, Louisiana, United States, 70006

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New Orleans, Louisiana, United States, 70112

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New Orleans, Louisiana, United States, 70121

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Shreveport, Louisiana, United States, 71105

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West Monroe, Louisiana, United States, 71291

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Baltimore, Maryland, United States, 21202

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New Bedford, Massachusetts, United States, 02740

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Novi, Michigan, United States, 48377

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Wyoming, Michigan, United States, 49519

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Flowood, Mississippi, United States, 39232

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Columbia, Missouri, United States, 65201

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Kansas City, Missouri, United States, 64131

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St Louis, Missouri, United States, 63123

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Las Vegas, Nevada, United States, 89106

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Las Vegas, Nevada, United States, 89109

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Reno, Nevada, United States, 89511

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Jackson, New Jersey, United States, 08527

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Ridgewood, New Jersey, United States, 07450

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Somers Point, New Jersey, United States, 08244

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Sparta, New Jersey, United States, 07871

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Buffalo, New York, United States, 14203

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Manhasset, New York, United States, 11030

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New York, New York, United States, 10016

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New York, New York, United States, 10021

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New York, New York, United States, 10029

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Rochester, New York, United States, 55905

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Chapel Hill, North Carolina, United States, 27514

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Charlotte, North Carolina, United States, 28204

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Durham, North Carolina, United States, 27710

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Fayetteville, North Carolina, United States, 28303

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Morehead City, North Carolina, United States, 28557

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New Bern, North Carolina, United States, 28562

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Raleigh, North Carolina, United States, 27612

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Statesville, North Carolina, United States, 28625

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Dayton, Ohio, United States, 45414

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Springboro, Ohio, United States, 45066

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Westlake, Ohio, United States, 44145

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Hershey, Pennsylvania, United States, 17033

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Philadelphia, Pennsylvania, United States, 19104

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Philadelphia, Pennsylvania, United States, 19107

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Pittsburgh, Pennsylvania, United States, 15213

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Charleston, South Carolina, United States, 29425

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Summerville, South Carolina, United States, 29485

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Chattanooga, Tennessee, United States, 37421

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Clarksville, Tennessee, United States, 37040

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Hermitage, Tennessee, United States, 37076

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Nashville, Tennessee, United States, 37211

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Amarillo, Texas, United States, 79106

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Austin, Texas, United States, 78745

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Austin, Texas, United States, 78757

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Austin, Texas, United States, 78757

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Bellaire, Texas, United States, 77401

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Brownsville, Texas, United States, 78520

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Corpus Christi, Texas, United States, 78404

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Dallas, Texas, United States, 75203

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Dallas, Texas, United States, 75216

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Dallas, Texas, United States, 75230

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Dallas, Texas, United States, 75234

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Dallas, Texas, United States, 75390

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Denison, Texas, United States, 75020

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Edinburg, Texas, United States, 78539

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Forney, Texas, United States, 75126

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Fort Worth, Texas, United States, 76104

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Houston, Texas, United States, 77004

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Houston, Texas, United States, 77074

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Houston, Texas, United States, 77079

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Houston, Texas, United States, 77079

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Lewisville, Texas, United States, 75057

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McAllen, Texas, United States, 78539

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Pasadena, Texas, United States, 77505

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San Antonio, Texas, United States, 78209

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San Antonio, Texas, United States, 78215

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San Antonio, Texas, United States, 78222

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San Antonio, Texas, United States, 78229

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San Antonio, Texas, United States, 78229

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San Antonio, Texas, United States, 78240

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San Antonio, Texas, United States, 782531

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San Antonio, Texas, United States, 78258

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San Marcos, Texas, United States, 78666-7502

Akero Clinical Study Site

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San Marcos, Texas, United States, 78666

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Waco, Texas, United States, 76710

Akero Clinical Study Site

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Waco, Texas, United States, 76712

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Webster, Texas, United States, 77598

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Wichita Falls, Texas, United States, 76301

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Ogden, Utah, United States, 84405

Akero Clinical Study Site

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Sandy City, Utah, United States, 84092

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Newport News, Virginia, United States, 23602

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Norfolk, Virginia, United States, 23502

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Richmond, Virginia, United States, 23226

Akero Clinical Study Site

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Richmond, Virginia, United States, 23235

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Richmond, Virginia, United States, 23249

Akero Clinical Study Site

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Richmond, Virginia, United States, 23298

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Roanoke, Virginia, United States, 24014

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Seattle, Washington, United States, 98105

Akero Clinical Study Site

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Spokane, Washington, United States, 99218

Akero Clinical Study Site

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Madison, Wisconsin, United States, 53705

Akero Clinical Study Site

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Edmonton, Alberta, Canada, T6G 2X8

Akero Clinical Study Site

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Hamilton, Ontario, Canada, L8S 4K1

Akero Clinical Study Site

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Toronto, Ontario, Canada, M6H 3M1

Akero Clinical Study Site

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Vaughan, Ontario, Canada, L4L 4Y7

Akero Clinical Study Site

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Montreal, Quebec, Canada, H2X 3E4

Akero Clinical Study Site

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Terrebonne, Quebec, Canada, J7B6B7

More Information

Sponsor

Akero Therapeutics, Inc

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-14. This information was provided to ClinicalTrials.gov by Akero Therapeutics, Inc on 2026-08-07.