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New drug efruxifermin aims to reverse liver scarring in NASH patients

NCT ID NCT06161571

Disease control Sponsor: Akero Therapeutics, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 study tests whether efruxifermin, given as a weekly shot, is safe and can improve liver health in 700 adults with NASH/MASH (a type of fatty liver disease). Participants receive either the drug or a placebo. The study tracks side effects and measures changes in liver stiffness and fibrosis scores. Results could lead to a new treatment option for this common liver condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Efruxifermin (a drug given as a shot under the skin)
What this could lead to
If successful, efruxifermin could become a new treatment option to reduce liver scarring and improve liver health in people with NASH/MASH.
What could go wrong
This is a Phase 3 trial, but results are not yet available. The drug may not prove effective or could have side effects. It is also tested in a specific group, so benefits may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 Exclusion Criteria: * 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 A reduced list of inclusion and exclusion criteria apply to participants in the open-label rollover extension. Other inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NAFLD/masld NASH/mash

Contacts and locations

Locations

  • Akero Clinical Study Site

    Birmingham, Alabama, 35209, United States

  • Akero Clinical Study Site

    Chandler, Arizona, 85224, United States

  • Akero Clinical Study Site

    Flagstaff, Arizona, 86001, United States

  • Akero Clinical Study Site

    Peoria, Arizona, 85381, United States

  • Akero Clinical Study Site

    Tucson, Arizona, 85712, United States

  • Akero Clinical Study Site

    Tucson, Arizona, 85715, United States

  • Akero Clinical Study Site

    Conway, Arkansas, 72032, United States

  • Akero Clinical Study Site

    Jonesboro, Arkansas, 72401, United States

  • Akero Clinical Study Site

    Little Rock, Arkansas, 72205, United States

  • Akero Clinical Study Site

    North Little Rock, Arkansas, 72117, United States

  • Akero Clinical Study Site

    Chula Vista, California, 91910, United States

  • Akero Clinical Study Site

    Coronado, California, 92118, United States

  • Akero Clinical Study Site

    Cypress, California, 90630, United States

  • Akero Clinical Study Site

    Inglewood, California, 90301, United States

  • Akero Clinical Study Site

    La Mesa, California, 91942, United States

  • Akero Clinical Study Site

    Lancaster, California, 93534, United States

  • Akero Clinical Study Site

    Los Angeles, California, 90036-4669, United States

  • Akero Clinical Study Site

    Los Angeles, California, 90057, United States

  • Akero Clinical Study Site

    Palm Springs, California, 92262, United States

  • Akero Clinical Study Site

    San Diego, California, 92120, United States

  • Akero Clinical Study Site

    San Diego, California, 92123, United States

  • Akero Clinical Study Site

    San Francisco, California, 94115, United States

  • Akero Clinical Study Site

    Santa Maria, California, 93458, United States

  • Akero Clinical Study Site

    Englewood, Colorado, 80113, United States

  • Akero Clinical Study Site

    Bradenton, Florida, 34208, United States

  • Akero Clinical Study Site

    Brandon, Florida, 33511, United States

  • Akero Clinical Study Site

    Fort Myers, Florida, 33912, United States

  • Akero Clinical Study Site

    Gainesville, Florida, 32610, United States

  • Akero Clinical Study Site

    Hialeah Gardens, Florida, 33016, United States

  • Akero Clinical Study Site

    Inverness, Florida, 34452, United States

  • Akero Clinical Study Site

    Jacksonville, Florida, 32256, United States

  • Akero Clinical Study Site

    Lady Lake, Florida, 32159, United States

  • Akero Clinical Study Site

    Lakewood Rch, Florida, 34211, United States

  • Akero Clinical Study Site

    Largo, Florida, 33777, United States

  • Akero Clinical Study Site

    Maitland, Florida, 32751, United States

  • Akero Clinical Study Site

    Miami, Florida, 33136, United States

  • Akero Clinical Study Site

    Miami Lakes, Florida, 33016, United States

  • Akero Clinical Study Site

    Naples, Florida, 34102, United States

  • Akero Clinical Study Site

    Ocala, Florida, 34471, United States

  • Akero Clinical Study Site

    Port Orange, Florida, 32127, United States

  • Akero Clinical Study Site

    Sarasota, Florida, 34240, United States

  • Akero Clinical Study Site

    The Villages, Florida, 32162, United States

  • Akero Clinical Study Site

    Venice, Florida, 34285, United States

  • Akero Clinical Study Site

    Viera, Florida, 32940, United States

  • Akero Clinical Study Site

    West Palm Beach, Florida, 33401, United States

  • Akero Clinical Study Site

    Winter Park, Florida, 32789, United States

  • Akero Clinical Study Site

    Winter Park, Florida, 32792, United States

  • Akero Clinical Study Site

    Columbus, Georgia, 31904, United States

  • Akero Clinical Study Site

    Gainesville, Georgia, 30501, United States

  • Akero Clinical Study Site

    Marietta, Georgia, 30060, United States

  • Akero Clinical Study Site

    South Bend, Indiana, 46635, United States

  • Akero Clinical Study Site

    West Des Moines, Iowa, 50265, United States

  • Akero Clinical Study Site

    Topeka, Kansas, 66606, United States

  • Akero Clinical Study Site

    Wichita, Kansas, 67205, United States

  • Akero Clinical Study Site

    Bastrop, Louisiana, 71220, United States

  • Akero Clinical Study Site

    Covington, Louisiana, 70433, United States

  • Akero Clinical Study Site

    Houma, Louisiana, 70363, United States

  • Akero Clinical Study Site

    Marrero, Louisiana, 70072, United States

  • Akero Clinical Study Site

    Metairie, Louisiana, 70006, United States

  • Akero Clinical Study Site

    New Orleans, Louisiana, 70121, United States

  • Akero Clinical Study Site

    Shreveport, Louisiana, 71103, United States

  • Akero Clinical Study Site

    Baltimore, Maryland, 21202, United States

  • Akero Clinical Study Site

    Glen Burnie, Maryland, 21061, United States

  • Akero Clinical Study Site

    Greenbelt, Maryland, 20770, United States

  • Akero Clinical Study Site

    South Dartmouth, Massachusetts, 02747, United States

  • Akero Clinical Study Site

    Southfield, Michigan, 48075, United States

  • Akero Clinical Study Site

    Wyoming, Michigan, 49519, United States

  • Akero Clinical Study Site

    Ypsilanti, Michigan, 48197, United States

  • Akero Clinical Study Site

    Columbia, Missouri, 65201, United States

  • Akero Clinical Study Site

    Kansas City, Missouri, 64131, United States

  • Akero Clinical Study Site

    Las Vegas, Nevada, 89106, United States

  • Akero Clinical Study Site

    Las Vegas, Nevada, 89109, United States

  • Akero Clinical Study Site

    Reno, Nevada, 89511, United States

  • Akero Clinical Study Site

    Brick, New Jersey, 08724, United States

  • Akero Clinical Study Site

    Florham Park, New Jersey, 07932, United States

  • Akero Clinical Study Site

    Somers Point, New Jersey, 08244, United States

  • Akero Clinical Study Site

    Sparta, New Jersey, 07871, United States

  • Akero Clinical Study Site

    Santa Fe, New Mexico, 87505, United States

  • Akero Clinical Study Site

    New York, New York, 10029, United States

  • Akero Clinical Study Site

    New York, New York, 10033, United States

  • Akero Clinical Study Site

    Chapel Hill, North Carolina, 27516, United States

  • Akero Clinical Study Site

    Charlotte, North Carolina, 28204, United States

  • Akero Clinical Study Site

    Fayetteville, North Carolina, 28304, United States

  • Akero Clinical Study Site

    Morehead City, North Carolina, 28557, United States

  • Akero Clinical Study Site

    New Bern, North Carolina, 28562, United States

  • Akero Clinical Study Site

    Raleigh, North Carolina, 27612, United States

  • Akero Clinical Study Site

    Statesville, North Carolina, 28625, United States

  • Akero Clinical Study Site

    Columbus, Ohio, 43213, United States

  • Akero Clinical Study Site

    Dayton, Ohio, 45414, United States

  • Akero Clinical Study Site

    Springboro, Ohio, 45066, United States

  • Akero Clinical Study Site

    Westlake, Ohio, 44145, United States

  • Akero Clinical Study Site

    Philadelphia, Pennsylvania, 19104, United States

  • Akero Clinical Study Site

    Philadelphia, Pennsylvania, 19107, United States

  • Akero Clinical Study Site

    Pittsburgh, Pennsylvania, 15213, United States

  • Akero Clinical Study Site

    Columbia, South Carolina, 29204, United States

  • Akero Clinical Study Site

    Summerville, South Carolina, 29485, United States

  • Akero Clinical Study Site

    Chattanooga, Tennessee, 37421, United States

  • Akero Clinical Study Site

    Clarksville, Tennessee, 37040, United States

  • Akero Clinical Study Site

    Hermitage, Tennessee, 37076, United States

  • Akero Clinical Study Site

    Nashville, Tennessee, 37211, United States

  • Akero Clinical Study Site

    Amarillo, Texas, 79106, United States

  • Akero Clinical Study Site

    Austin, Texas, 78745, United States

  • Akero Clinical Study Site

    Austin, Texas, 78757, United States

  • Akero Clinical Study Site

    Bellaire, Texas, 77401, United States

  • Akero Clinical Study Site

    Brownsville, Texas, 78520, United States

  • Akero Clinical Study Site

    Corpus Christi, Texas, 78404, United States

  • Akero Clinical Study Site

    Dallas, Texas, 75203, United States

  • Akero Clinical Study Site

    Dallas, Texas, 75230, United States

  • Akero Clinical Study Site

    Dallas, Texas, 75234, United States

  • Akero Clinical Study Site

    Dallas, Texas, 75390, United States

  • Akero Clinical Study Site

    Edinburg, Texas, 78539, United States

  • Akero Clinical Study Site

    Fort Worth, Texas, 76104, United States

  • Akero Clinical Study Site

    Houston, Texas, 77030, United States

  • Akero Clinical Study Site

    Houston, Texas, 77079, United States

  • Akero Clinical Study Site

    Houston, Texas, 77084, United States

  • Akero Clinical Study Site

    Lewisville, Texas, 75057, United States

  • Akero Clinical Study Site

    McAllen, Texas, 78504, United States

  • Akero Clinical Study Site

    San Antonio, Texas, 78215, United States

  • Akero Clinical Study Site

    San Antonio, Texas, 78222, United States

  • Akero Clinical Study Site

    San Antonio, Texas, 78229, United States

  • Akero Clinical Study Site

    San Antonio, Texas, 78258, United States

  • Akero Clinical Study Site

    San Marcos, Texas, 78666-7502, United States

  • Akero Clinical Study Site

    Waco, Texas, 76710, United States

  • Akero Clinical Study Site

    Webster, Texas, 77598, United States

  • Akero Clinical Study Site

    Wichita Falls, Texas, 76301, United States

  • Akero Clinical Study Site

    Ogden, Utah, 84405, United States

  • Akero Clinical Study Site

    Salt Lake City, Utah, 84117, United States

  • Akero Clinical Study Site

    Sandy City, Utah, 84092, United States

  • Akero Clinical Study Site

    South Ogden, Utah, 84405, United States

  • Akero Clinical Study Site

    Falls Church, Virginia, 22042-3300, United States

  • Akero Clinical Study Site

    Norfolk, Virginia, 23502, United States

  • Akero Clinical Study Site

    Richmond, Virginia, 23226, United States

  • Akero Clinical Study Site

    Richmond, Virginia, 23236, United States

  • Akero Clinical Study Site

    Richmond, Virginia, 23249, United States

  • Akero Clinical Study Site

    Richmond, Virginia, 23298, United States

  • Akero Clinical Study Site

    Roanoke, Virginia, 24014, United States

  • Akero Clinical Study Site

    Suffolk, Virginia, 23435, United States

  • Akero Clinical Study Site

    Seattle, Washington, 98105, United States

  • Akero Clinical Study Site

    Spokane, Washington, 99218, United States

  • Akero Clinical Study Site

    Ramos Mejía, Buenos Aires, B1704ETD, Argentina

  • Akero Clinical Study Site

    Buenos Aires, Distrito Federal, C1125ABE, Argentina

  • Akero Clinical Study Site

    Buenos Aires, C1118AAT, Argentina

  • Akero Clinical Study Site

    Buenos Aires, C1280AEB, Argentina

  • Akero Clinical Study Site

    Broadmeadow, New South Wales, 2292, Australia

  • Akero Clinical Study Site

    Westmead, New South Wales, 2145, Australia

  • Akero Clinical Study Site

    Adelaide, South Australia, 5000, Australia

  • Akero Clinical Study Site

    Clayton, Victoria, 3168, Australia

  • Akero Clinical Study Site

    Epping, Victoria, 3076, Australia

  • Akero Clinical Study Site

    Heidelberg, Victoria, 3084, Australia

  • Akero Clinical Study Site

    Melbourne, Victoria, 3004, Australia

  • Akero Clinical Study Site

    Murdoch, Western Australia, 6150, Australia

  • Akero Clinical Study Site

    Perth, Western Australia, 6000, Australia

  • Akero Clinical Study Site

    Edmonton, Alberta, T6G 2X8, Canada

  • Akero Clinical Study Site

    Hamilton, Ontario, L8S 4K1, Canada

  • Akero Clinical Study Site

    Toronto, Ontario, M6H 3M1, Canada

  • Akero Clinical Study Site

    Vaughan, Ontario, L4L 4Y7, Canada

  • Akero Clinical Study Site

    Terrebonne, Quebec, J7B6B7, Canada

  • Akero Clinical Study Site

    Surat, Gujarat, 395002, India

  • Akero Clinical Study Site

    Vadodara, Gujarat, 390007, India

  • Akero Clinical Study Site

    Thiruvananthapuram, Kerala, 695011, India

  • Akero Clinical Study Site

    Dahegaon, Maharashtra, 441108, India

  • Akero Clinical Study Site

    Mumbai, Maharashtra, 400012, India

  • Akero Clinical Study Site

    Nagpur, Maharashtra, 440010, India

  • Akero Clinical Study Site

    Pune, Maharashtra, 412201, India

  • Akero Clinical Study Site

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

  • Akero Clinical Study Site

    Chandigarh, Punjab, 160012, India

  • Akero Clinical Study Site

    Jaipur, Rajasthan, 302001, India

  • Akero Clinical Study Site

    Coimbatore, Tamil Nadu, 641005, India

  • Akero Clinical Study Site

    Hyderabad, Telangana, 500 004, India

  • Akero Clinical Study Site

    Varanasi, Uttar Pradesh, 221005, India

  • Akero Clinical Study Site

    Kolkata, West Bengal, 700020, India

  • Akero Clinical Study Site

    Kolkata, West Bengal, 700073, India

  • Akero Clinical Study Site

    Kolkata, West Bengal, 700150, India

  • Akero Clinical Study Site

    Petah Tikva, Central District, 4941492, Israel

  • Akero Clinical Study Site

    Ramat Gan, Central District, 5265601, Israel

  • Akero Clinical Study Site

    Haifa, Haifa District, 3109601, Israel

  • Akero Clinical Study Site

    Haifa, Haifa District, 3436212, Israel

  • Akero Clinical Study Site

    Afula, Northern District, 1834111, Israel

  • Akero Clinical Study Site

    Nahariya, Northern District, 22100, Israel

  • Akero Clinical Study Site

    Nazareth, Northern District, 16234, Israel

  • Akero Clinical Study Site

    Jerusalem, 9103102, Israel

  • Akero Clinical Study Site

    Jerusalem, 9112001, Israel

  • Akero Clinical Study Site

    Tel Aviv, 6423906, Israel

  • Akero Clinical Study Site

    Mexico City, Mexico City, 06700, Mexico

  • Akero Clinical Study Site

    Manati, 00674, Puerto Rico

  • Akero Clinical Study Site

    San Juan, 00927, Puerto Rico

  • Akero Clinical Study Site

    Daegu, Daegu Gwang'yeogsi, 41944, South Korea

  • Akero Clinical Study Site

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

  • Akero Clinical Study Site

    Incheon, Gyeonggi-do, 22332, South Korea

  • Akero Clinical Study Site

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

  • Akero Clinical Study Site

    Daegu, Gyeongsangbuk-do, 42601, South Korea

  • Akero Clinical Study Site

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

  • Akero Clinical Study Site

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Akero Clinical Study Site

    Olten, Canton of Solothurn, 4600, Switzerland

  • Akero Clinical Study Site

    Bern, 3010, Switzerland

  • Akero Clinical Study Site

    Sankt Gallen, 9007, Switzerland

  • Akero Clinical Study Site

    Changhua, Changhua, 500, Taiwan

  • Akero Clinical Study Site

    Taichung, Taichung, 40447, Taiwan

  • Akero Clinical Study Site

    Tainan, Tainan, 73657, Taiwan

  • Akero Clinical Study Site

    Taipei, 10048, Taiwan

  • Akero Clinical Study Site

    Yenimahalle, Ankara, 06500, Turkey (Türkiye)

  • Akero Clinical Study Site

    Bornova, İzmir, 35100, Turkey (Türkiye)

  • Akero Clinical Study Site

    Bursa, 16059, Turkey (Türkiye)

  • Akero Clinical Study Site

    Rize, 53020, Turkey (Türkiye)

  • Akero Clinical Study Site

    Liverpool, England, L9 7AL, United Kingdom

  • Akero Clinical Study Site

    London, England, E1 1BB, United Kingdom

  • Akero Clinical Study Site

    London, England, NW3 2QG, United Kingdom

  • Akero Clinical Study Site

    London, England, SE5 9RS, United Kingdom

  • Akero Clinical Study Site

    London, England, SW10 9NH, United Kingdom

  • Akero Clinical Study Site

    London, England, W2 1NY, United Kingdom

  • Akero Clinical Study Site

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

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