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)
NCT ID: NCT06161571
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
700 participants
INTERVENTIONAL
2023-11-10
2026-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NCT06215716
A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
NCT06528314
A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
NCT04767529
A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
NCT03976401
A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)
NCT05039450
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
EFX 50 mg
Efruxifermin
Administered by subcutaneous (SC) injection
Placebo
Placebo
Administered by SC injection
EFX 50 mg (Open-Label Rollover)
Efruxifermin
Administered by subcutaneous (SC) injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Efruxifermin
Administered by subcutaneous (SC) injection
Placebo
Administered by SC injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Type 1 or unstable Type 2 diabetes
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Akero Therapeutics, Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Akero Clinical Study Site
Birmingham, Alabama, United States
Akero Clinical Study Site
Chandler, Arizona, United States
Akero Clinical Study Site
Flagstaff, Arizona, United States
Akero Clinical Study Site
Peoria, Arizona, United States
Akero Clinical Study Site
Tucson, Arizona, United States
Akero Clinical Study Site
Tucson, Arizona, United States
Akero Clinical Study Site
Conway, Arkansas, United States
Akero Clinical Study Site
Jonesboro, Arkansas, United States
Akero Clinical Study Site
Little Rock, Arkansas, United States
Akero Clinical Study Site
North Little Rock, Arkansas, United States
Akero Clinical Study Site
Chula Vista, California, United States
Akero Clinical Study Site
Coronado, California, United States
Akero Clinical Study Site
Cypress, California, United States
Akero Clinical Study Site
Inglewood, California, United States
Akero Clinical Study Site
La Mesa, California, United States
Akero Clinical Study Site
Lancaster, California, United States
Akero Clinical Study Site
Los Angeles, California, United States
Akero Clinical Study Site
Los Angeles, California, United States
Akero Clinical Study Site
Palm Springs, California, United States
Akero Clinical Study Site
San Diego, California, United States
Akero Clinical Study Site
San Diego, California, United States
Akero Clinical Study Site
San Francisco, California, United States
Akero Clinical Study Site
Santa Maria, California, United States
Akero Clinical Study Site
Englewood, Colorado, United States
Akero Clinical Study Site
Bradenton, Florida, United States
Akero Clinical Study Site
Brandon, Florida, United States
Akero Clinical Study Site
Fort Myers, Florida, United States
Akero Clinical Study Site
Gainesville, Florida, United States
Akero Clinical Study Site
Hialeah Gardens, Florida, United States
Akero Clinical Study Site
Inverness, Florida, United States
Akero Clinical Study Site
Jacksonville, Florida, United States
Akero Clinical Study Site
Lady Lake, Florida, United States
Akero Clinical Study Site
Lakewood Rch, Florida, United States
Akero Clinical Study Site
Largo, Florida, United States
Akero Clinical Study Site
Maitland, Florida, United States
Akero Clinical Study Site
Miami, Florida, United States
Akero Clinical Study Site
Miami Lakes, Florida, United States
Akero Clinical Study Site
Naples, Florida, United States
Akero Clinical Study Site
Ocala, Florida, United States
Akero Clinical Study Site
Port Orange, Florida, United States
Akero Clinical Study Site
Sarasota, Florida, United States
Akero Clinical Study Site
The Villages, Florida, United States
Akero Clinical Study Site
Venice, Florida, United States
Akero Clinical Study Site
Viera, Florida, United States
Akero Clinical Study Site
West Palm Beach, Florida, United States
Akero Clinical Study Site
Winter Park, Florida, United States
Akero Clinical Study Site
Winter Park, Florida, United States
Akero Clinical Study Site
Columbus, Georgia, United States
Akero Clinical Study Site
Gainesville, Georgia, United States
Akero Clinical Study Site
Marietta, Georgia, United States
Akero Clinical Study Site
South Bend, Indiana, United States
Akero Clinical Study Site
West Des Moines, Iowa, United States
Akero Clinical Study Site
Topeka, Kansas, United States
Akero Clinical Study Site
Wichita, Kansas, United States
Akero Clinical Study Site
Bastrop, Louisiana, United States
Akero Clinical Study Site
Covington, Louisiana, United States
Akero Clinical Study Site
Houma, Louisiana, United States
Akero Clinical Study Site
Marrero, Louisiana, United States
Akero Clinical Study Site
Metairie, Louisiana, United States
Akero Clinical Study Site
New Orleans, Louisiana, United States
Akero Clinical Study Site
Shreveport, Louisiana, United States
Akero Clinical Study Site
Baltimore, Maryland, United States
Akero Clinical Study Site
Glen Burnie, Maryland, United States
Akero Clinical Study Site
Greenbelt, Maryland, United States
Akero Clinical Study Site
South Dartmouth, Massachusetts, United States
Akero Clinical Study Site
Southfield, Michigan, United States
Akero Clinical Study Site
Wyoming, Michigan, United States
Akero Clinical Study Site
Ypsilanti, Michigan, United States
Akero Clinical Study Site
Columbia, Missouri, United States
Akero Clinical Study Site
Kansas City, Missouri, United States
Akero Clinical Study Site
Las Vegas, Nevada, United States
Akero Clinical Study Site
Las Vegas, Nevada, United States
Akero Clinical Study Site
Reno, Nevada, United States
Akero Clinical Study Site
Brick, New Jersey, United States
Akero Clinical Study Site
Florham Park, New Jersey, United States
Akero Clinical Study Site
Somers Point, New Jersey, United States
Akero Clinical Study Site
Sparta, New Jersey, United States
Akero Clinical Study Site
Santa Fe, New Mexico, United States
Akero Clinical Study Site
New York, New York, United States
Akero Clinical Study Site
New York, New York, United States
Akero Clinical Study Site
Chapel Hill, North Carolina, United States
Akero Clinical Study Site
Charlotte, North Carolina, United States
Akero Clinical Study Site
Fayetteville, North Carolina, United States
Akero Clinical Study Site
Morehead City, North Carolina, United States
Akero Clinical Study Site
New Bern, North Carolina, United States
Akero Clinical Study Site
Raleigh, North Carolina, United States
Akero Clinical Study Site
Statesville, North Carolina, United States
Akero Clinical Study Site
Columbus, Ohio, United States
Akero Clinical Study Site
Dayton, Ohio, United States
Akero Clinical Study Site
Springboro, Ohio, United States
Akero Clinical Study Site
Westlake, Ohio, United States
Akero Clinical Study Site
Philadelphia, Pennsylvania, United States
Akero Clinical Study Site
Philadelphia, Pennsylvania, United States
Akero Clinical Study Site
Pittsburgh, Pennsylvania, United States
Akero Clinical Study Site
Columbia, South Carolina, United States
Akero Clinical Study Site
Summerville, South Carolina, United States
Akero Clinical Study Site
Chattanooga, Tennessee, United States
Akero Clinical Study Site
Clarksville, Tennessee, United States
Akero Clinical Study Site
Hermitage, Tennessee, United States
Akero Clinical Study Site
Nashville, Tennessee, United States
Akero Clinical Study Site
Amarillo, Texas, United States
Akero Clinical Study Site
Austin, Texas, United States
Akero Clinical Study Site
Austin, Texas, United States
Akero Clinical Study Site
Bellaire, Texas, United States
Akero Clinical Study Site
Brownsville, Texas, United States
Akero Clinical Study Site
Corpus Christi, Texas, United States
Akero Clinical Study Site
Dallas, Texas, United States
Akero Clinical Study Site
Dallas, Texas, United States
Akero Clinical Study Site
Dallas, Texas, United States
Akero Clinical Study Site
Dallas, Texas, United States
Akero Clinical Study Site
Edinburg, Texas, United States
Akero Clinical Study Site
Fort Worth, Texas, United States
Akero Clinical Study Site
Houston, Texas, United States
Akero Clinical Study Site
Houston, Texas, United States
Akero Clinical Study Site
Houston, Texas, United States
Akero Clinical Study Site
Lewisville, Texas, United States
Akero Clinical Study Site
McAllen, Texas, United States
Akero Clinical Study Site
San Antonio, Texas, United States
Akero Clinical Study Site
San Antonio, Texas, United States
Akero Clinical Study Site
San Antonio, Texas, United States
Akero Clinical Study Site
San Antonio, Texas, United States
Akero Clinical Study Site
San Marcos, Texas, United States
Akero Clinical Study Site
Waco, Texas, United States
Akero Clinical Study Site
Webster, Texas, United States
Akero Clinical Study Site
Wichita Falls, Texas, United States
Akero Clinical Study Site
Ogden, Utah, United States
Akero Clinical Study Site
Salt Lake City, Utah, United States
Akero Clinical Study Site
Sandy City, Utah, United States
Akero Clinical Study Site
South Ogden, Utah, United States
Akero Clinical Study Site
Falls Church, Virginia, United States
Akero Clinical Study Site
Norfolk, Virginia, United States
Akero Clinical Study Site
Richmond, Virginia, United States
Akero Clinical Study Site
Richmond, Virginia, United States
Akero Clinical Study Site
Richmond, Virginia, United States
Akero Clinical Study Site
Richmond, Virginia, United States
Akero Clinical Study Site
Roanoke, Virginia, United States
Akero Clinical Study Site
Suffolk, Virginia, United States
Akero Clinical Study Site
Seattle, Washington, United States
Akero Clinical Study Site
Spokane, Washington, United States
Akero Clinical Study Site
Ramos Mejía, Buenos Aires, Argentina
Akero Clinical Study Site
Buenos Aires, Distrito Federal, Argentina
Akero Clinical Study Site
Buenos Aires, , Argentina
Akero Clinical Study Site
Buenos Aires, , Argentina
Akero Clinical Study Site
Broadmeadow, New South Wales, Australia
Akero Clinical Study Site
Westmead, New South Wales, Australia
Akero Clinical Study Site
Adelaide, South Australia, Australia
Akero Clinical Study Site
Clayton, Victoria, Australia
Akero Clinical Study Site
Epping, Victoria, Australia
Akero Clinical Study Site
Heidelberg, Victoria, Australia
Akero Clinical Study Site
Melbourne, Victoria, Australia
Akero Clinical Study Site
Murdoch, Western Australia, Australia
Akero Clinical Study Site
Perth, Western Australia, Australia
Akero Clinical Study Site
Edmonton, Alberta, Canada
Akero Clinical Study Site
Hamilton, Ontario, Canada
Akero Clinical Study Site
Toronto, Ontario, Canada
Akero Clinical Study Site
Vaughan, Ontario, Canada
Akero Clinical Study Site
Terrebonne, Quebec, Canada
Akero Clinical Study Site
Surat, Gujarat, India
Akero Clinical Study Site
Vadodara, Gujarat, India
Akero Clinical Study Site
Thiruvananthapuram, Kerala, India
Akero Clinical Study Site
Dahegaon, Maharashtra, India
Akero Clinical Study Site
Mumbai, Maharashtra, India
Akero Clinical Study Site
Nagpur, Maharashtra, India
Akero Clinical Study Site
Pune, Maharashtra, India
Akero Clinical Study Site
New Delhi, National Capital Territory of Delhi, India
Akero Clinical Study Site
Chandigarh, Punjab, India
Akero Clinical Study Site
Jaipur, Rajasthan, India
Akero Clinical Study Site
Coimbatore, Tamil Nadu, India
Akero Clinical Study Site
Hyderabad, Telangana, India
Akero Clinical Study Site
Varanasi, Uttar Pradesh, India
Akero Clinical Study Site
Kolkata, West Bengal, India
Akero Clinical Study Site
Kolkata, West Bengal, India
Akero Clinical Study Site
Kolkata, West Bengal, India
Akero Clinical Study Site
Petah Tikva, Central District, Israel
Akero Clinical Study Site
Ramat Gan, Central District, Israel
Akero Clinical Study Site
Haifa, Haifa District, Israel
Akero Clinical Study Site
Haifa, Haifa District, Israel
Akero Clinical Study Site
Afula, Northern District, Israel
Akero Clinical Study Site
Nahariya, Northern District, Israel
Akero Clinical Study Site
Nazareth, Northern District, Israel
Akero Clinical Study Site
Jerusalem, , Israel
Akero Clinical Study Site
Jerusalem, , Israel
Akero Clinical Study Site
Tel Aviv, , Israel
Akero Clinical Study Site
Mexico City, Mexico City, Mexico
Akero Clinical Study Site
Manatí, , Puerto Rico
Akero Clinical Study Site
San Juan, , Puerto Rico
Akero Clinical Study Site
Daegu, Daegu Gwang'yeogsi, South Korea
Akero Clinical Study Site
Goyang-si, Gyeonggi-do, South Korea
Akero Clinical Study Site
Incheon, Gyeonggi-do, South Korea
Akero Clinical Study Site
Seongnam-si, Gyeonggi-do, South Korea
Akero Clinical Study Site
Daegu, Gyeongsangbuk-do, South Korea
Akero Clinical Study Site
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea
Akero Clinical Study Site
Seoul, Seoul Teugbyeolsi, South Korea
Akero Clinical Study Site
Olten, Canton of Solothurn, Switzerland
Akero Clinical Study Site
Bern, , Switzerland
Akero Clinical Study Site
Sankt Gallen, , Switzerland
Akero Clinical Study Site
Changhua, Changhua, Taiwan
Akero Clinical Study Site
Taichung, Taichung, Taiwan
Akero Clinical Study Site
Tainan City, Tainan, Taiwan
Akero Clinical Study Site
Taipei, , Taiwan
Akero Clinical Study Site
Yenimahalle, Ankara, Turkey (Türkiye)
Akero Clinical Study Site
Bornova, İzmir, Turkey (Türkiye)
Akero Clinical Study Site
Bursa, , Turkey (Türkiye)
Akero Clinical Study Site
Rize, , Turkey (Türkiye)
Akero Clinical Study Site
Liverpool, England, United Kingdom
Akero Clinical Study Site
London, England, United Kingdom
Akero Clinical Study Site
London, England, United Kingdom
Akero Clinical Study Site
London, England, United Kingdom
Akero Clinical Study Site
London, England, United Kingdom
Akero Clinical Study Site
London, England, United Kingdom
Akero Clinical Study Site
Newcastle upon Tyne, England, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AK-US-001-0107
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.