Recruiting
Phase 3

Efruxifermin

Sponsor:

Akero Therapeutics, Inc

Code:

NCT06528314

Conditions

NASH - Nonalcoholic Steatohepatitis

MASH - Metabolic Dysfunction-Associated Steatohepatitis

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 compensated cirrhosis due to NASH/MASH.

Conditions

NASH - Nonalcoholic Steatohepatitis

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Study ID

NCT06528314

Start date

Sep 4, 2024

Status verified date

Sep, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

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.

Study Design

Enrollment

2150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: EFX 50 mg

placebo comparator: Placebo

Interventions

Efruxifermin

Administered by subcutaneous injection

Placebo

Administered by subcutaneous injection

Primary outcome measure

  • Time from randomization to the first significant clinical event including disease progression, liver decompensation events, etc. [ Time Frame: 5 years ]
  • Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis [ Time Frame: 96 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

Akero Clinical Study Site

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Chandler, Arizona, United States, 85224

Akero Clinical Study Site

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Peoria, Arizona, United States, 85381

Akero Clinical Study Site

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Scottsdale, Arizona, United States, 85258

Akero Clinical Study Site

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Tucson, Arizona, United States, 85712

Akero Clinical Study Site

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Tucson, Arizona, United States, 85712

Akero Clinical Study Site

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Tucson, Arizona, United States, 85713

Akero Clinical Study Site

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Tucson, Arizona, United States, 85715

Akero Clinical Study Site

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Little Rock, Arkansas, United States, 72205

Akero Clinical Study Site

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North Little Rock, Arkansas, United States, 72117

Akero Clinical Study Site

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Coronado, California, United States, 92118

Akero Clinical Study Site

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Escondido, California, United States, 92025

Akero Clinical Study Site

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Folsom, California, United States, 95630

Akero Clinical Study Site

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Fountain Valley, California, United States, 92708

Akero Clinical Study Site

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Lancaster, California, United States, 93534

Akero Clinical Study Site

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Long Beach, California, United States, 90815

Akero Clinical Study Site

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Los Angeles, California, United States, 90048

Akero Clinical Study Site

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Newport Beach, California, United States, 92663

Akero Clinical Study Site

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Orange, California, United States, 92868

Akero Clinical Study Site

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Pasadena, California, United States, 91105

Akero Clinical Study Site

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Redwood City, California, United States, 94063

Akero Clinical Study Site

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Sacramento, California, United States, 95817

Akero Clinical Study Site

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San Francisco, California, United States, 94115

Akero Clinical Study Site

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San Francisco, California, United States, 94117

Akero Clinical Study Site

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San Jose, California, United States, 95116

Akero Clinical Study Site

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Tarzana, California, United States, 91356

Akero Clinical Study Site

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Aurora, Colorado, United States, 80045

Akero Clinical Study Site

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Colorado Springs, Colorado, United States, 80907

Akero Clinical Study Site

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Englewood, Colorado, United States, 80113

Akero Clinical Study Site

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New Haven, Connecticut, United States, 06511

Akero Clinical Study Site

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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

Akero Clinical Study Site

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Brandon, Florida, United States, 33511

Akero Clinical Study Site

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Cutler Bay, Florida, United States, 33189

Akero Clinical Study Site

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Daytona Beach, Florida, United States, 32114

Akero Clinical Study Site

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Doral, Florida, United States, 33126

Akero Clinical Study Site

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Fort Myers, Florida, United States, 33912

Akero Clinical Study Site

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Hialeah Gardens, Florida, United States, 33016

Akero Clinical Study Site

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Inverness, Florida, United States, 34452

Akero Clinical Study Site

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Lady Lake, Florida, United States, 32159

Akero Clinical Study Site

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Lakewood Rch, Florida, United States, 34211

Akero Clinical Study Site

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Largo, Florida, United States, 33777

Akero Clinical Study Site

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Lehigh Acres, Florida, United States, 33936

Akero Clinical Study Site

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Margate, Florida, United States, 33063

Akero Clinical Study Site

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Miami, Florida, United States, 33136

Akero Clinical Study Site

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Miami, Florida, United States, 33175

Akero Clinical Study Site

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Miami Gardens, Florida, United States, 33014

Akero Clinical Study Site

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Naples, Florida, United States, 34102

Akero Clinical Study Site

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New Port Richey, Florida, United States, 34653

Akero Clinical Study Site

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Ocala, Florida, United States, 34471

Akero Clinical Study Site

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Orlando, Florida, United States, 32807

Akero Clinical Study Site

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Pembroke Pines, Florida, United States, 33027

Akero Clinical Study Site

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Riverview, Florida, United States, 33578

Akero Clinical Study Site

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Sarasota, Florida, United States, 34240

Akero Clinical Study Site

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Temple Terrace, Florida, United States, 33617

Akero Clinical Study Site

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Weston, Florida, United States, 33331

Akero Clinical Study Site

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Zephyrhills, Florida, United States, 33542

Akero Clinical Study Site

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Atlanta, Georgia, United States, 30309

Akero Clinical Study Site

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Gainesville, Georgia, United States, 30501

Akero Clinical Study Site

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Marietta, Georgia, United States, 30060

Akero Clinical Study Site

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Chicago, Illinois, United States, 60611

Akero Clinical Study Site

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Hammond, Indiana, United States, 46324

Akero Clinical Study Site

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Indianapolis, Indiana, United States, 46202

Akero Clinical Study Site

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South Bend, Indiana, United States, 46635

Akero Clinical Study Site

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West Des Moines, Iowa, United States, 50265

Akero Clinical Study Site

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Topeka, Kansas, United States, 66606

Akero Clinical Study Site

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Louisville, Kentucky, United States, 40202

Akero Clinical Study Site

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Bastrop, Louisiana, United States, 71220

Akero Clinical Study Site

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Covington, Louisiana, United States, 70433

Akero Clinical Study Site

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Houma, Louisiana, United States, 70363

Akero Clinical Study Site

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Lafayette, Louisiana, United States, 70503

Akero Clinical Study Site

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Marrero, Louisiana, United States, 70072

Akero Clinical Study Site

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Metairie, Louisiana, United States, 70006

Akero Clinical Study Site

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Shreveport, Louisiana, United States, 71105

Akero Clinical Study Site

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West Monroe, Louisiana, United States, 71291

Akero Clinical Study Site

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Baltimore, Maryland, United States, 21202

Akero Clinical Study Site

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Bethesda, Maryland, United States, 20889-0004

Akero Clinical Study Site

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South Dartmouth, Massachusetts, United States, 02747

Akero Clinical Study Site

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Novi, Michigan, United States, 48377

Akero Clinical Study Site

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Southfield, Michigan, United States, 48075

Akero Clinical Study Site

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Rochester, Minnesota, United States, 55905

Akero Clinical Study Site

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Flowood, Mississippi, United States, 39232

Akero Clinical Study Site

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Columbia, Missouri, United States, 65201

Akero Clinical Study Site

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Kansas City, Missouri, United States, 64131

Akero Clinical Study Site

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St Louis, Missouri, United States, 63110

Akero Clinical Study Site

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St Louis, Missouri, United States, 63123

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Las Vegas, Nevada, United States, 89106

Akero Clinical Study Site

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Jackson, New Jersey, United States, 08527

Akero Clinical Study Site

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Somers Point, New Jersey, United States, 08244

Akero Clinical Study Site

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Sparta, New Jersey, United States, 07871

Akero Clinical Study Site

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Buffalo, New York, United States, 14203

Akero Clinical Study Site

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Manhasset, New York, United States, 11030

Akero Clinical Study Site

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New York, New York, United States, 10016

Akero Clinical Study Site

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New York, New York, United States, 10021

Akero Clinical Study Site

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New York, New York, United States, 10029

Akero Clinical Study Site

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Rochester, New York, United States, 14642

Akero Clinical Study Site

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Chapel Hill, North Carolina, United States, 27516

Akero Clinical Study Site

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Charlotte, North Carolina, United States, 28204

Akero Clinical Study Site

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Charlotte, North Carolina, United States, 28207

Akero Clinical Study Site

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Durham, North Carolina, United States, 27710

Akero Clinical Study Site

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Fayetteville, North Carolina, United States, 28304

Akero Clinical Study Site

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Morehead City, North Carolina, United States, 28557

Akero Clinical Study Site

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Raleigh, North Carolina, United States, 27612

Akero Clinical Study Site

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Statesville, North Carolina, United States, 28625

Akero Clinical Study Site

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Akron, Ohio, United States, 44320

Akero Clinical Study Site

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Springboro, Ohio, United States, 45066

Akero Clinical Study Site

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Westlake, Ohio, United States, 44145

Akero Clinical Study Site

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Oklahoma City, Oklahoma, United States, 73112

Akero Clinical Study Site

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Hershey, Pennsylvania, United States, 17033

Akero Clinical Study Site

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Philadelphia, Pennsylvania, United States, 19104

Akero Clinical Study Site

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Philadelphia, Pennsylvania, United States, 19107

Akero Clinical Study Site

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Pittsburgh, Pennsylvania, United States, 15213

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Charleston, South Carolina, United States, 29425

Akero Clinical Study Site

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Columbia, South Carolina, United States, 29204

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Summerville, South Carolina, United States, 29485

Akero Clinical Study Site

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Clarksville, Tennessee, United States, 37040

Akero Clinical Study Site

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Hermitage, Tennessee, United States, 37076

Akero Clinical Study Site

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Nashville, Tennessee, United States, 37211

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Arlington, Texas, United States, 76012

Akero Clinical Study Site

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Austin, Texas, United States, 78745

Akero Clinical Study Site

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Austin, Texas, United States, 78757

Akero Clinical Study Site

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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

Akero Clinical Study Site

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Dallas, Texas, United States, 75216

Akero Clinical Study Site

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Dallas, Texas, United States, 75234

Akero Clinical Study Site

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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

Akero Clinical Study Site

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Edinburg, Texas, United States, 78539

Akero Clinical Study Site

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Fort Sam Houston, Texas, United States, 78234

Akero Clinical Study Site

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Houston, Texas, United States, 77030

Akero Clinical Study Site

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Houston, Texas, United States, 77030

Akero Clinical Study Site

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Houston, Texas, United States, 77030

Akero Clinical Study Site

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Houston, Texas, United States, 77074

Akero Clinical Study Site

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Houston, Texas, United States, 77079

Akero Clinical Study Site

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Kingwood, Texas, United States, 77339

Akero Clinical Study Site

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Pasadena, Texas, United States, 77505

Akero Clinical Study Site

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San Antonio, Texas, United States, 78222

Akero Clinical Study Site

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San Antonio, Texas, United States, 78229

Akero Clinical Study Site

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San Antonio, Texas, United States, 78229

Akero Clinical Study Site

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San Antonio, Texas, United States, 78251

Akero Clinical Study Site

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Sugar Land, Texas, United States, 77478

Akero Clinical Study Site

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Waco, Texas, United States, 76710

Akero Clinical Study Site

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Waco, Texas, United States, 76712

Akero Clinical Study Site

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Webster, Texas, United States, 77598

Akero Clinical Study Site

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Wichita Falls, Texas, United States, 76301

Akero Clinical Study Site

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Norfolk, Virginia, United States, 23502

Akero Clinical Study Site

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Richmond, Virginia, United States, 23226-1925

Akero Clinical Study Site

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Richmond, Virginia, United States, 23236

Akero Clinical Study Site

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Richmond, Virginia, United States, 23249

Akero Clinical Study Site

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Richmond, Virginia, United States, 23284

Akero Clinical Study Site

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Roanoke, Virginia, United States, 24014

Akero Clinical Study Site

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Seattle, Washington, United States, 98105

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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Toronto, Ontario, Canada, M5G 2C4

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 0A9

Akero Clinical Study Site

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Terrebonne, Quebec, Canada, J7B6B7

More Information

Sponsor

Akero Therapeutics, Inc

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Akero Therapeutics, Inc on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.