A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

NCT06161571 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: AK-US-001-0107
• Study Type: interventional
• Target: 700
• Locations: 13 countries
• Sites: 211

Brief Summary

The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.

Conditions

NASH/MASH; NAFLD/MASLD

Outcome Measures

Primary Outcomes (4)

• Extent of exposure

  A participant's extent of exposure to study drug (weeks) will be generated from the data recorded in the study drug administration eCRF.

  52 Weeks

• Number of participants with adverse events

  An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not related to the study drug.

  52 Weeks

• Number of participants with adverse events by severity

  All AEs, both serious and non-serious, will be assessed for severity using the Common Terminology Criteria for Adverse Events v5.0.

  52 Weeks

• Number of participants with clinically significant changes in clinical assessments

  Clinical assessments include clinical laboratory tests, electrocardiogram, ultrasounds, vital sign assessments, and concomitant medication usage.

  52 Weeks

Secondary Outcomes (12)

• Percentage of participants with reduction in enhanced liver fibrosis (ELF) score by ≥ 0.5 and reduction in liver stiffness measurement (LSM) by ≥ 30%

  52 Weeks

• Change from baseline in non-invasive marker ELF score

  52 Weeks

• Change from baseline in non-invasive marker pro-peptide of type 3 procollagen (Pro-C3)

  52 Weeks

• Change from baseline in non-invasive marker liver stiffness assessed by transient elastography (kPa, CAP)

  52 Weeks

• Percentage of participants with a reduction in ELF score by ≥ 0.5

  52 Weeks

Study Arms (3)

EFX 50 mg

EXPERIMENTAL

Drug: Efruxifermin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

EFX 50 mg (Open-Label Rollover)

EXPERIMENTAL

Drug: Efruxifermin

Interventions

Efruxifermin DRUG

Administered by subcutaneous (SC) injection

EFX 50 mg; EFX 50 mg (Open-Label Rollover)

Placebo DRUG

Administered by SC injection

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Main Study Only:
• Males and non-pregnant, non-lactating females between 18 - 80 (between 19-80 in the Republic of Korea) years of age inclusive, on the day of signing informed consent
• 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
• Suspected or confirmed diagnosis of NASH/MASH or NAFLD/MASLD or non-invasively diagnosed NASH/MASH or NAFLD/MASLD
• Open-Label Rollover
• Prior participation in a previous Akero Phase 2 study

You may not qualify if:

• Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results, including but not limited to: alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis \[PBC\], primary sclerosing cholangitis \[PSC\], autoimmune hepatitis), drug induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency
• Type 1 or unstable Type 2 diabetes

Sponsors & Collaborators

• Akero Therapeutics, Inc: lead

Study Sites (211)

Akero Clinical Study Site

Birmingham, Alabama, 35209, United States

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Akero Clinical Study Site

Chandler, Arizona, 85224, United States

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Akero Clinical Study Site

Flagstaff, Arizona, 86001, United States

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Akero Clinical Study Site

Peoria, Arizona, 85381, United States

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Akero Clinical Study Site

Tucson, Arizona, 85712, United States

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Akero Clinical Study Site

Tucson, Arizona, 85715, United States

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Akero Clinical Study Site

Conway, Arkansas, 72032, United States

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Akero Clinical Study Site

Jonesboro, Arkansas, 72401, United States

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Akero Clinical Study Site

Little Rock, Arkansas, 72205, United States

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Akero Clinical Study Site

North Little Rock, Arkansas, 72117, United States

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Akero Clinical Study Site

Chula Vista, California, 91910, United States

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Akero Clinical Study Site

Coronado, California, 92118, United States

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Akero Clinical Study Site

Cypress, California, 90630, United States

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Akero Clinical Study Site

Inglewood, California, 90301, United States

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Akero Clinical Study Site

La Mesa, California, 91942, United States

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Akero Clinical Study Site

Lancaster, California, 93534, United States

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Akero Clinical Study Site

Los Angeles, California, 90036-4669, United States

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Los Angeles, California, 90057, United States

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Akero Clinical Study Site

Palm Springs, California, 92262, United States

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Akero Clinical Study Site

San Diego, California, 92120, United States

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Akero Clinical Study Site

San Diego, California, 92123, United States

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Akero Clinical Study Site

San Francisco, California, 94115, United States

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Akero Clinical Study Site

Santa Maria, California, 93458, United States

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Akero Clinical Study Site

Englewood, Colorado, 80113, United States

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Akero Clinical Study Site

Bradenton, Florida, 34208, United States

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Akero Clinical Study Site

Brandon, Florida, 33511, United States

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Akero Clinical Study Site

Fort Myers, Florida, 33912, United States

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Akero Clinical Study Site

Gainesville, Florida, 32610, United States

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Akero Clinical Study Site

Hialeah Gardens, Florida, 33016, United States

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Akero Clinical Study Site

Inverness, Florida, 34452, United States

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Akero Clinical Study Site

Jacksonville, Florida, 32256, United States

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Akero Clinical Study Site

Lady Lake, Florida, 32159, United States

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Akero Clinical Study Site

Lakewood Rch, Florida, 34211, United States

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Akero Clinical Study Site

Largo, Florida, 33777, United States

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Akero Clinical Study Site

Maitland, Florida, 32751, United States

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Akero Clinical Study Site

Miami, Florida, 33136, United States

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Akero Clinical Study Site

Miami Lakes, Florida, 33016, United States

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Akero Clinical Study Site

Naples, Florida, 34102, United States

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Akero Clinical Study Site

Ocala, Florida, 34471, United States

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Akero Clinical Study Site

Port Orange, Florida, 32127, United States

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Akero Clinical Study Site

Sarasota, Florida, 34240, United States

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Akero Clinical Study Site

The Villages, Florida, 32162, United States

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Akero Clinical Study Site

Venice, Florida, 34285, United States

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Akero Clinical Study Site

Viera, Florida, 32940, United States

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Akero Clinical Study Site

West Palm Beach, Florida, 33401, United States

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Akero Clinical Study Site

Winter Park, Florida, 32789, United States

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Akero Clinical Study Site

Winter Park, Florida, 32792, United States

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Akero Clinical Study Site

Columbus, Georgia, 31904, United States

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Akero Clinical Study Site

Gainesville, Georgia, 30501, United States

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Akero Clinical Study Site

Marietta, Georgia, 30060, United States

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Akero Clinical Study Site

South Bend, Indiana, 46635, United States

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Akero Clinical Study Site

West Des Moines, Iowa, 50265, United States

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Akero Clinical Study Site

Topeka, Kansas, 66606, United States

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Akero Clinical Study Site

Wichita, Kansas, 67205, United States

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Akero Clinical Study Site

Bastrop, Louisiana, 71220, United States

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Akero Clinical Study Site

Covington, Louisiana, 70433, United States

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Akero Clinical Study Site

Houma, Louisiana, 70363, United States

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Akero Clinical Study Site

Marrero, Louisiana, 70072, United States

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Akero Clinical Study Site

Metairie, Louisiana, 70006, United States

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Akero Clinical Study Site

New Orleans, Louisiana, 70121, United States

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Akero Clinical Study Site

Shreveport, Louisiana, 71103, United States

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Akero Clinical Study Site

Baltimore, Maryland, 21202, United States

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Akero Clinical Study Site

Glen Burnie, Maryland, 21061, United States

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Akero Clinical Study Site

Greenbelt, Maryland, 20770, United States

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Akero Clinical Study Site

South Dartmouth, Massachusetts, 02747, United States

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Southfield, Michigan, 48075, United States

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Akero Clinical Study Site

Wyoming, Michigan, 49519, United States

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Akero Clinical Study Site

Ypsilanti, Michigan, 48197, United States

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Akero Clinical Study Site

Columbia, Missouri, 65201, United States

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Akero Clinical Study Site

Kansas City, Missouri, 64131, United States

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Akero Clinical Study Site

Las Vegas, Nevada, 89106, United States

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Akero Clinical Study Site

Las Vegas, Nevada, 89109, United States

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Akero Clinical Study Site

Reno, Nevada, 89511, United States

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Akero Clinical Study Site

Brick, New Jersey, 08724, United States

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Akero Clinical Study Site

Florham Park, New Jersey, 07932, United States

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Akero Clinical Study Site

Somers Point, New Jersey, 08244, United States

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Akero Clinical Study Site

Sparta, New Jersey, 07871, United States

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Akero Clinical Study Site

Santa Fe, New Mexico, 87505, United States

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Akero Clinical Study Site

New York, New York, 10029, United States

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Akero Clinical Study Site

New York, New York, 10033, United States

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Akero Clinical Study Site

Chapel Hill, North Carolina, 27516, United States

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Akero Clinical Study Site

Charlotte, North Carolina, 28204, United States

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Akero Clinical Study Site

Fayetteville, North Carolina, 28304, United States

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Akero Clinical Study Site

Morehead City, North Carolina, 28557, United States

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Akero Clinical Study Site

New Bern, North Carolina, 28562, United States

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Akero Clinical Study Site

Raleigh, North Carolina, 27612, United States

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Akero Clinical Study Site

Statesville, North Carolina, 28625, United States

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Akero Clinical Study Site

Columbus, Ohio, 43213, United States

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Akero Clinical Study Site

Dayton, Ohio, 45414, United States

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Akero Clinical Study Site

Springboro, Ohio, 45066, United States

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Akero Clinical Study Site

Westlake, Ohio, 44145, United States

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Akero Clinical Study Site

Philadelphia, Pennsylvania, 19104, United States

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Akero Clinical Study Site

Philadelphia, Pennsylvania, 19107, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Akero Clinical Study Site

Columbia, South Carolina, 29204, United States

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Summerville, South Carolina, 29485, United States

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Akero Clinical Study Site

Chattanooga, Tennessee, 37421, United States

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Akero Clinical Study Site

Clarksville, Tennessee, 37040, United States

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Akero Clinical Study Site

Hermitage, Tennessee, 37076, United States

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Akero Clinical Study Site

Nashville, Tennessee, 37211, United States

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Akero Clinical Study Site

Amarillo, Texas, 79106, United States

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Akero Clinical Study Site

Austin, Texas, 78745, United States

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Akero Clinical Study Site

Austin, Texas, 78757, United States

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Akero Clinical Study Site

Bellaire, Texas, 77401, United States

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Akero Clinical Study Site

Brownsville, Texas, 78520, United States

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Akero Clinical Study Site

Corpus Christi, Texas, 78404, United States

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Akero Clinical Study Site

Dallas, Texas, 75203, United States

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Akero Clinical Study Site

Dallas, Texas, 75230, United States

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Akero Clinical Study Site

Dallas, Texas, 75234, United States

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Akero Clinical Study Site

Dallas, Texas, 75390, United States

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Akero Clinical Study Site

Edinburg, Texas, 78539, United States

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Akero Clinical Study Site

Fort Worth, Texas, 76104, United States

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Akero Clinical Study Site

Houston, Texas, 77030, United States

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Akero Clinical Study Site

Houston, Texas, 77079, United States

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Akero Clinical Study Site

Houston, Texas, 77084, United States

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Akero Clinical Study Site

Lewisville, Texas, 75057, United States

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Akero Clinical Study Site

McAllen, Texas, 78504, United States

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Akero Clinical Study Site

San Antonio, Texas, 78215, United States

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Akero Clinical Study Site

San Antonio, Texas, 78222, United States

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Akero Clinical Study Site

San Antonio, Texas, 78229, United States

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Akero Clinical Study Site

San Antonio, Texas, 78258, United States

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Akero Clinical Study Site

San Marcos, Texas, 78666-7502, United States

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Akero Clinical Study Site

Waco, Texas, 76710, United States

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Akero Clinical Study Site

Webster, Texas, 77598, United States

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Akero Clinical Study Site

Wichita Falls, Texas, 76301, United States

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Ogden, Utah, 84405, United States

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Akero Clinical Study Site

Salt Lake City, Utah, 84117, United States

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Akero Clinical Study Site

Sandy City, Utah, 84092, United States

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Akero Clinical Study Site

South Ogden, Utah, 84405, United States

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Akero Clinical Study Site

Falls Church, Virginia, 22042-3300, United States

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Norfolk, Virginia, 23502, United States

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Akero Clinical Study Site

Richmond, Virginia, 23226, United States

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Akero Clinical Study Site

Richmond, Virginia, 23236, United States

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Akero Clinical Study Site

Richmond, Virginia, 23249, United States

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Akero Clinical Study Site

Richmond, Virginia, 23298, United States

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Akero Clinical Study Site

Roanoke, Virginia, 24014, United States

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Akero Clinical Study Site

Suffolk, Virginia, 23435, United States

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Akero Clinical Study Site

Seattle, Washington, 98105, United States

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Akero Clinical Study Site

Spokane, Washington, 99218, United States

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Akero Clinical Study Site

Ramos Mejía, Buenos Aires, B1704ETD, Argentina

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Buenos Aires, Distrito Federal, C1125ABE, Argentina

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Akero Clinical Study Site

Buenos Aires, C1118AAT, Argentina

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Buenos Aires, C1280AEB, Argentina

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Akero Clinical Study Site

Broadmeadow, New South Wales, 2292, Australia

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Akero Clinical Study Site

Westmead, New South Wales, 2145, Australia

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Akero Clinical Study Site

Adelaide, South Australia, 5000, Australia

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Akero Clinical Study Site

Clayton, Victoria, 3168, Australia

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Akero Clinical Study Site

Epping, Victoria, 3076, Australia

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Akero Clinical Study Site

Heidelberg, Victoria, 3084, Australia

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Akero Clinical Study Site

Melbourne, Victoria, 3004, Australia

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Akero Clinical Study Site

Murdoch, Western Australia, 6150, Australia

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Akero Clinical Study Site

Perth, Western Australia, 6000, Australia

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Akero Clinical Study Site

Edmonton, Alberta, T6G 2X8, Canada

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Hamilton, Ontario, L8S 4K1, Canada

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Toronto, Ontario, M6H 3M1, Canada

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Vaughan, Ontario, L4L 4Y7, Canada

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Terrebonne, Quebec, J7B6B7, Canada

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Akero Clinical Study Site

Surat, Gujarat, 395002, India

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Vadodara, Gujarat, 390007, India

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Akero Clinical Study Site

Thiruvananthapuram, Kerala, 695011, India

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Akero Clinical Study Site

Dahegaon, Maharashtra, 441108, India

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Akero Clinical Study Site

Mumbai, Maharashtra, 400012, India

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Akero Clinical Study Site

Nagpur, Maharashtra, 440010, India

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Akero Clinical Study Site

Pune, Maharashtra, 412201, India

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Akero Clinical Study Site

New Delhi, National Capital Territory of Delhi, 110029, India

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Akero Clinical Study Site

Chandigarh, Punjab, 160012, India

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Akero Clinical Study Site

Jaipur, Rajasthan, 302001, India

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Akero Clinical Study Site

Coimbatore, Tamil Nadu, 641005, India

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Akero Clinical Study Site

Hyderabad, Telangana, 500 004, India

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Varanasi, Uttar Pradesh, 221005, India

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Akero Clinical Study Site

Kolkata, West Bengal, 700020, India

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Akero Clinical Study Site

Kolkata, West Bengal, 700073, India

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Akero Clinical Study Site

Kolkata, West Bengal, 700150, India

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Akero Clinical Study Site

Petah Tikva, Central District, 4941492, Israel

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Akero Clinical Study Site

Ramat Gan, Central District, 5265601, Israel

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Akero Clinical Study Site

Haifa, Haifa District, 3109601, Israel

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Akero Clinical Study Site

Haifa, Haifa District, 3436212, Israel

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Akero Clinical Study Site

Afula, Northern District, 1834111, Israel

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Akero Clinical Study Site

Nahariya, Northern District, 22100, Israel

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Akero Clinical Study Site

Nazareth, Northern District, 16234, Israel

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Akero Clinical Study Site

Jerusalem, 9103102, Israel

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Akero Clinical Study Site

Jerusalem, 9112001, Israel

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Akero Clinical Study Site

Tel Aviv, 6423906, Israel

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Akero Clinical Study Site

Mexico City, Mexico City, 06700, Mexico

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Akero Clinical Study Site

Manati, 00674, Puerto Rico

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Akero Clinical Study Site

San Juan, 00927, Puerto Rico

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Akero Clinical Study Site

Daegu, Daegu Gwang'yeogsi, 41944, South Korea

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Akero Clinical Study Site

Goyang-si, Gyeonggi-do, 1232, South Korea

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Akero Clinical Study Site

Incheon, Gyeonggi-do, 22332, South Korea

Location

Akero Clinical Study Site

Seongnam-si, Gyeonggi-do, 13496, South Korea

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Akero Clinical Study Site

Daegu, Gyeongsangbuk-do, 42601, South Korea

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Akero Clinical Study Site

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 04763, South Korea

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Akero Clinical Study Site

Seoul, Seoul Teugbyeolsi, 03080, South Korea

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Akero Clinical Study Site

Olten, Canton of Solothurn, 4600, Switzerland

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Akero Clinical Study Site

Bern, 3010, Switzerland

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Akero Clinical Study Site

Sankt Gallen, 9007, Switzerland

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Akero Clinical Study Site

Changhua, Changhua, 500, Taiwan

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Akero Clinical Study Site

Taichung, Taichung, 40447, Taiwan

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Akero Clinical Study Site

Tainan, Tainan, 73657, Taiwan

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Akero Clinical Study Site

Taipei, 10048, Taiwan

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Akero Clinical Study Site

Yenimahalle, Ankara, 06500, Turkey (Türkiye)

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Akero Clinical Study Site

Bornova, İzmir, 35100, Turkey (Türkiye)

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Akero Clinical Study Site

Bursa, 16059, Turkey (Türkiye)

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Akero Clinical Study Site

Rize, 53020, Turkey (Türkiye)

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Akero Clinical Study Site

Liverpool, England, L9 7AL, United Kingdom

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Akero Clinical Study Site

London, England, E1 1BB, United Kingdom

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Akero Clinical Study Site

London, England, NW3 2QG, United Kingdom

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Akero Clinical Study Site

London, England, SE5 9RS, United Kingdom

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Akero Clinical Study Site

London, England, SW10 9NH, United Kingdom

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Akero Clinical Study Site

London, England, W2 1NY, United Kingdom

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Akero Clinical Study Site

Newcastle upon Tyne, England, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 8, 2023
• Study Start: November 10, 2023
• Primary Completion: March 3, 2026
• Study Completion (Estimated): June 19, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AR (4); PR (2); KR (7); CH (3); TW (4); IL (10); GB (7); ME (1); TU (4); AU (9); US (139); CA (5); IN (16)