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)

April 28, 2026 updated by: Akero Therapeutics, Inc

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of 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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

700

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1118AAT
    - Akero Clinical Study Site
  - Buenos Aires, Argentina, C1280AEB
    - Akero Clinical Study Site
- Buenos Aires
  - Ramos Mejía, Buenos Aires, Argentina, B1704ETD
    - Akero Clinical Study Site
- Distrito Federal
  - Buenos Aires, Distrito Federal, Argentina, C1125ABE
    - Akero Clinical Study Site
Australia
- New South Wales
  - Broadmeadow, New South Wales, Australia, 2292
    - Akero Clinical Study Site
  - Westmead, New South Wales, Australia, 2145
    - Akero Clinical Study Site
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Akero Clinical Study Site
- Victoria
  - Clayton, Victoria, Australia, 3168
    - Akero Clinical Study Site
  - Epping, Victoria, Australia, 3076
    - Akero Clinical Study Site
  - Heidelberg, Victoria, Australia, 3084
    - Akero Clinical Study Site
  - Melbourne, Victoria, Australia, 3004
    - Akero Clinical Study Site
- Western Australia
  - Murdoch, Western Australia, Australia, 6150
    - Akero Clinical Study Site
  - Perth, Western Australia, Australia, 6000
    - Akero Clinical Study Site
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 2X8
    - Akero Clinical Study Site
- Ontario
  - Hamilton, Ontario, Canada, L8S 4K1
    - Akero Clinical Study Site
  - Toronto, Ontario, Canada, M6H 3M1
    - Akero Clinical Study Site
  - Vaughan, Ontario, Canada, L4L 4Y7
    - Akero Clinical Study Site
- Quebec
  - Terrebonne, Quebec, Canada, J7B6B7
    - Akero Clinical Study Site
India
- Gujarat
  - Surat, Gujarat, India, 395002
    - Akero Clinical Study Site
  - Vadodara, Gujarat, India, 390007
    - Akero Clinical Study Site
- Kerala
  - Thiruvananthapuram, Kerala, India, 695011
    - Akero Clinical Study Site
- Maharashtra
  - Dahegaon, Maharashtra, India, 441108
    - Akero Clinical Study Site
  - Mumbai, Maharashtra, India, 400012
    - Akero Clinical Study Site
  - Nagpur, Maharashtra, India, 440010
    - Akero Clinical Study Site
  - Pune, Maharashtra, India, 412201
    - Akero Clinical Study Site
- National Capital Territory of Delhi
  - New Delhi, National Capital Territory of Delhi, India, 110029
    - Akero Clinical Study Site
- Punjab
  - Chandigarh, Punjab, India, 160012
    - Akero Clinical Study Site
- Rajasthan
  - Jaipur, Rajasthan, India, 302001
    - Akero Clinical Study Site
- Tamil Nadu
  - Coimbatore, Tamil Nadu, India, 641005
    - Akero Clinical Study Site
- Telangana
  - Hyderabad, Telangana, India, 500 004
    - Akero Clinical Study Site
- Uttar Pradesh
  - Varanasi, Uttar Pradesh, India, 221005
    - Akero Clinical Study Site
- West Bengal
  - Kolkata, West Bengal, India, 700020
    - Akero Clinical Study Site
  - Kolkata, West Bengal, India, 700073
    - Akero Clinical Study Site
  - Kolkata, West Bengal, India, 700150
    - Akero Clinical Study Site
Israel
- - Jerusalem, Israel, 9103102
    - Akero Clinical Study Site
  - Jerusalem, Israel, 9112001
    - Akero Clinical Study Site
  - Tel Aviv, Israel, 6423906
    - Akero Clinical Study Site
- Central District
  - Petah Tikva, Central District, Israel, 4941492
    - Akero Clinical Study Site
  - Ramat Gan, Central District, Israel, 5265601
    - Akero Clinical Study Site
- Haifa District
  - Haifa, Haifa District, Israel, 3109601
    - Akero Clinical Study Site
  - Haifa, Haifa District, Israel, 3436212
    - Akero Clinical Study Site
- Northern District
  - Afula, Northern District, Israel, 1834111
    - Akero Clinical Study Site
  - Nahariya, Northern District, Israel, 22100
    - Akero Clinical Study Site
  - Nazareth, Northern District, Israel, 16234
    - Akero Clinical Study Site
Mexico
- Mexico City
  - Mexico City, Mexico City, Mexico, 06700
    - Akero Clinical Study Site
Puerto Rico
- - Manati, Puerto Rico, 00674
    - Akero Clinical Study Site
  - San Juan, Puerto Rico, 00927
    - Akero Clinical Study Site
South Korea
- Daegu Gwang'yeogsi
  - Daegu, Daegu Gwang'yeogsi, South Korea, 41944
    - Akero Clinical Study Site
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, South Korea, 1232
    - Akero Clinical Study Site
  - Incheon, Gyeonggi-do, South Korea, 22332
    - Akero Clinical Study Site
  - Seongnam-si, Gyeonggi-do, South Korea, 13496
    - Akero Clinical Study Site
- Gyeongsangbuk-do
  - Daegu, Gyeongsangbuk-do, South Korea, 42601
    - Akero Clinical Study Site
- Seoul Teugbyeolsi
  - Seoul, Seoul Teugbyeolsi, South Korea, 03080
    - Akero Clinical Study Site
- Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
  - Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea, 04763
    - Akero Clinical Study Site
Switzerland
- - Bern, Switzerland, 3010
    - Akero Clinical Study Site
  - Sankt Gallen, Switzerland, 9007
    - Akero Clinical Study Site
- Canton of Solothurn
  - Olten, Canton of Solothurn, Switzerland, 4600
    - Akero Clinical Study Site
Taiwan
- - Taipei, Taiwan, 10048
    - Akero Clinical Study Site
- Changhua
  - Changhua, Changhua, Taiwan, 500
    - Akero Clinical Study Site
- Taichung
  - Taichung, Taichung, Taiwan, 40447
    - Akero Clinical Study Site
- Tainan
  - Tainan, Tainan, Taiwan, 73657
    - Akero Clinical Study Site
Turkey (Türkiye)
- - Bursa, Turkey (Türkiye), 16059
    - Akero Clinical Study Site
  - Rize, Turkey (Türkiye), 53020
    - Akero Clinical Study Site
- Ankara
  - Yenimahalle, Ankara, Turkey (Türkiye), 06500
    - Akero Clinical Study Site
- İzmir
  - Bornova, İzmir, Turkey (Türkiye), 35100
    - Akero Clinical Study Site
United Kingdom
- England
  - Liverpool, England, United Kingdom, L9 7AL
    - Akero Clinical Study Site
  - London, England, United Kingdom, E1 1BB
    - Akero Clinical Study Site
  - London, England, United Kingdom, NW3 2QG
    - Akero Clinical Study Site
  - London, England, United Kingdom, SE5 9RS
    - Akero Clinical Study Site
  - London, England, United Kingdom, SW10 9NH
    - Akero Clinical Study Site
  - London, England, United Kingdom, W2 1NY
    - Akero Clinical Study Site
  - Newcastle upon Tyne, England, United Kingdom, NE7 7DN
    - Akero Clinical Study Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35209
    - Akero Clinical Study Site
- Arizona
  - Chandler, Arizona, United States, 85224
    - Akero Clinical Study Site
  - Flagstaff, Arizona, United States, 86001
    - Akero Clinical Study Site
  - Peoria, Arizona, United States, 85381
    - Akero Clinical Study Site
  - Tucson, Arizona, United States, 85712
    - Akero Clinical Study Site
  - Tucson, Arizona, United States, 85715
    - Akero Clinical Study Site
- Arkansas
  - Conway, Arkansas, United States, 72032
    - Akero Clinical Study Site
  - Jonesboro, Arkansas, United States, 72401
    - Akero Clinical Study Site
  - Little Rock, Arkansas, United States, 72205
    - Akero Clinical Study Site
  - North Little Rock, Arkansas, United States, 72117
    - Akero Clinical Study Site
- California
  - Chula Vista, California, United States, 91910
    - Akero Clinical Study Site
  - Coronado, California, United States, 92118
    - Akero Clinical Study Site
  - Cypress, California, United States, 90630
    - Akero Clinical Study Site
  - Inglewood, California, United States, 90301
    - Akero Clinical Study Site
  - La Mesa, California, United States, 91942
    - Akero Clinical Study Site
  - Lancaster, California, United States, 93534
    - Akero Clinical Study Site
  - Los Angeles, California, United States, 90057
    - Akero Clinical Study Site
  - Los Angeles, California, United States, 90036-4669
    - Akero Clinical Study Site
  - Palm Springs, California, United States, 92262
    - Akero Clinical Study Site
  - San Diego, California, United States, 92120
    - Akero Clinical Study Site
  - San Diego, California, United States, 92123
    - Akero Clinical Study Site
  - San Francisco, California, United States, 94115
    - Akero Clinical Study Site
  - Santa Maria, California, United States, 93458
    - Akero Clinical Study Site
- Colorado
  - Englewood, Colorado, United States, 80113
    - Akero Clinical Study Site
- Florida
  - Bradenton, Florida, United States, 34208
    - Akero Clinical Study Site
  - Brandon, Florida, United States, 33511
    - Akero Clinical Study Site
  - Fort Myers, Florida, United States, 33912
    - Akero Clinical Study Site
  - Gainesville, Florida, United States, 32610
    - Akero Clinical Study Site
  - Hialeah Gardens, Florida, United States, 33016
    - Akero Clinical Study Site
  - Inverness, Florida, United States, 34452
    - Akero Clinical Study Site
  - Jacksonville, Florida, United States, 32256
    - Akero Clinical Study Site
  - Lady Lake, Florida, United States, 32159
    - Akero Clinical Study Site
  - Lakewood Rch, Florida, United States, 34211
    - Akero Clinical Study Site
  - Largo, Florida, United States, 33777
    - Akero Clinical Study Site
  - Maitland, Florida, United States, 32751
    - Akero Clinical Study Site
  - Miami, Florida, United States, 33136
    - Akero Clinical Study Site
  - Miami Lakes, Florida, United States, 33016
    - Akero Clinical Study Site
  - Naples, Florida, United States, 34102
    - Akero Clinical Study Site
  - Ocala, Florida, United States, 34471
    - Akero Clinical Study Site
  - Port Orange, Florida, United States, 32127
    - Akero Clinical Study Site
  - Sarasota, Florida, United States, 34240
    - Akero Clinical Study Site
  - The Villages, Florida, United States, 32162
    - Akero Clinical Study Site
  - Venice, Florida, United States, 34285
    - Akero Clinical Study Site
  - Viera, Florida, United States, 32940
    - Akero Clinical Study Site
  - West Palm Beach, Florida, United States, 33401
    - Akero Clinical Study Site
  - Winter Park, Florida, United States, 32789
    - Akero Clinical Study Site
  - Winter Park, Florida, United States, 32792
    - Akero Clinical Study Site
- Georgia
  - Columbus, Georgia, United States, 31904
    - Akero Clinical Study Site
  - Gainesville, Georgia, United States, 30501
    - Akero Clinical Study Site
  - Marietta, Georgia, United States, 30060
    - Akero Clinical Study Site
- Indiana
  - South Bend, Indiana, United States, 46635
    - Akero Clinical Study Site
- Iowa
  - West Des Moines, Iowa, United States, 50265
    - Akero Clinical Study Site
- Kansas
  - Topeka, Kansas, United States, 66606
    - Akero Clinical Study Site
  - Wichita, Kansas, United States, 67205
    - Akero Clinical Study Site
- Louisiana
  - Bastrop, Louisiana, United States, 71220
    - Akero Clinical Study Site
  - Covington, Louisiana, United States, 70433
    - Akero Clinical Study Site
  - Houma, Louisiana, United States, 70363
    - Akero Clinical Study Site
  - Marrero, Louisiana, United States, 70072
    - Akero Clinical Study Site
  - Metairie, Louisiana, United States, 70006
    - Akero Clinical Study Site
  - New Orleans, Louisiana, United States, 70121
    - Akero Clinical Study Site
  - Shreveport, Louisiana, United States, 71103
    - Akero Clinical Study Site
- Maryland
  - Baltimore, Maryland, United States, 21202
    - Akero Clinical Study Site
  - Glen Burnie, Maryland, United States, 21061
    - Akero Clinical Study Site
  - Greenbelt, Maryland, United States, 20770
    - Akero Clinical Study Site
- Massachusetts
  - South Dartmouth, Massachusetts, United States, 02747
    - Akero Clinical Study Site
- Michigan
  - Southfield, Michigan, United States, 48075
    - Akero Clinical Study Site
  - Wyoming, Michigan, United States, 49519
    - Akero Clinical Study Site
  - Ypsilanti, Michigan, United States, 48197
    - Akero Clinical Study Site
- Missouri
  - Columbia, Missouri, United States, 65201
    - Akero Clinical Study Site
  - Kansas City, Missouri, United States, 64131
    - Akero Clinical Study Site
- Nevada
  - Las Vegas, Nevada, United States, 89109
    - Akero Clinical Study Site
  - Las Vegas, Nevada, United States, 89106
    - Akero Clinical Study Site
  - Reno, Nevada, United States, 89511
    - Akero Clinical Study Site
- New Jersey
  - Brick, New Jersey, United States, 08724
    - Akero Clinical Study Site
  - Florham Park, New Jersey, United States, 07932
    - Akero Clinical Study Site
  - Somers Point, New Jersey, United States, 08244
    - Akero Clinical Study Site
  - Sparta, New Jersey, United States, 07871
    - Akero Clinical Study Site
- New Mexico
  - Santa Fe, New Mexico, United States, 87505
    - Akero Clinical Study Site
- New York
  - New York, New York, United States, 10029
    - Akero Clinical Study Site
  - New York, New York, United States, 10033
    - Akero Clinical Study Site
- North Carolina
  - Chapel Hill, North Carolina, United States, 27516
    - Akero Clinical Study Site
  - Charlotte, North Carolina, United States, 28204
    - Akero Clinical Study Site
  - Fayetteville, North Carolina, United States, 28304
    - Akero Clinical Study Site
  - Morehead City, North Carolina, United States, 28557
    - Akero Clinical Study Site
  - New Bern, North Carolina, United States, 28562
    - Akero Clinical Study Site
  - Raleigh, North Carolina, United States, 27612
    - Akero Clinical Study Site
  - Statesville, North Carolina, United States, 28625
    - Akero Clinical Study Site
- Ohio
  - Columbus, Ohio, United States, 43213
    - Akero Clinical Study Site
  - Dayton, Ohio, United States, 45414
    - Akero Clinical Study Site
  - Springboro, Ohio, United States, 45066
    - Akero Clinical Study Site
  - Westlake, Ohio, United States, 44145
    - Akero Clinical Study Site
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - Akero Clinical Study Site
  - Philadelphia, Pennsylvania, United States, 19107
    - Akero Clinical Study Site
  - Pittsburgh, Pennsylvania, United States, 15213
    - Akero Clinical Study Site
- South Carolina
  - Columbia, South Carolina, United States, 29204
    - Akero Clinical Study Site
  - Summerville, South Carolina, United States, 29485
    - Akero Clinical Study Site
- Tennessee
  - Chattanooga, Tennessee, United States, 37421
    - Akero Clinical Study Site
  - Clarksville, Tennessee, United States, 37040
    - Akero Clinical Study Site
  - Hermitage, Tennessee, United States, 37076
    - Akero Clinical Study Site
  - Nashville, Tennessee, United States, 37211
    - Akero Clinical Study Site
- Texas
  - Amarillo, Texas, United States, 79106
    - Akero Clinical Study Site
  - Austin, Texas, United States, 78757
    - Akero Clinical Study Site
  - Austin, Texas, United States, 78745
    - Akero Clinical Study Site
  - Bellaire, Texas, United States, 77401
    - Akero Clinical Study Site
  - Brownsville, Texas, United States, 78520
    - Akero Clinical Study Site
  - Corpus Christi, Texas, United States, 78404
    - Akero Clinical Study Site
  - Dallas, Texas, United States, 75234
    - Akero Clinical Study Site
  - Dallas, Texas, United States, 75203
    - Akero Clinical Study Site
  - Dallas, Texas, United States, 75230
    - Akero Clinical Study Site
  - Dallas, Texas, United States, 75390
    - Akero Clinical Study Site
  - Edinburg, Texas, United States, 78539
    - Akero Clinical Study Site
  - Fort Worth, Texas, United States, 76104
    - Akero Clinical Study Site
  - Houston, Texas, United States, 77030
    - Akero Clinical Study Site
  - Houston, Texas, United States, 77079
    - Akero Clinical Study Site
  - Houston, Texas, United States, 77084
    - Akero Clinical Study Site
  - Lewisville, Texas, United States, 75057
    - Akero Clinical Study Site
  - McAllen, Texas, United States, 78504
    - Akero Clinical Study Site
  - San Antonio, Texas, United States, 78215
    - Akero Clinical Study Site
  - San Antonio, Texas, United States, 78229
    - Akero Clinical Study Site
  - San Antonio, Texas, United States, 78222
    - Akero Clinical Study Site
  - San Antonio, Texas, United States, 78258
    - Akero Clinical Study Site
  - San Marcos, Texas, United States, 78666-7502
    - Akero Clinical Study Site
  - Waco, Texas, United States, 76710
    - Akero Clinical Study Site
  - Webster, Texas, United States, 77598
    - Akero Clinical Study Site
  - Wichita Falls, Texas, United States, 76301
    - Akero Clinical Study Site
- Utah
  - Ogden, Utah, United States, 84405
    - Akero Clinical Study Site
  - Salt Lake City, Utah, United States, 84117
    - Akero Clinical Study Site
  - Sandy City, Utah, United States, 84092
    - Akero Clinical Study Site
  - South Ogden, Utah, United States, 84405
    - Akero Clinical Study Site
- Virginia
  - Falls Church, Virginia, United States, 22042-3300
    - Akero Clinical Study Site
  - Norfolk, Virginia, United States, 23502
    - Akero Clinical Study Site
  - Richmond, Virginia, United States, 23298
    - Akero Clinical Study Site
  - Richmond, Virginia, United States, 23249
    - Akero Clinical Study Site
  - Richmond, Virginia, United States, 23226
    - Akero Clinical Study Site
  - Richmond, Virginia, United States, 23236
    - Akero Clinical Study Site
  - Roanoke, Virginia, United States, 24014
    - Akero Clinical Study Site
  - Suffolk, Virginia, United States, 23435
    - Akero Clinical Study Site
- Washington
  - Seattle, Washington, United States, 98105
    - Akero Clinical Study Site
  - Spokane, Washington, United States, 99218
    - Akero Clinical Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo Administered by SC injection
Experimental: EFX 50 mg	Drug: Efruxifermin Administered by subcutaneous (SC) injection
Experimental: EFX 50 mg (Open-Label Rollover)	Drug: Efruxifermin Administered by subcutaneous (SC) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extent of exposure Time Frame: 52 Weeks	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 Time Frame: 52 Weeks	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 Time Frame: 52 Weeks	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 Time Frame: 52 Weeks	Clinical assessments include clinical laboratory tests, electrocardiogram, ultrasounds, vital sign assessments, and concomitant medication usage.	52 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in non-invasive marker pro-peptide of type 3 procollagen (Pro-C3) Time Frame: 52 Weeks		52 Weeks
Change from baseline in non-invasive marker liver stiffness assessed by transient elastography (kPa, CAP) Time Frame: 52 Weeks		52 Weeks
Change from baseline in lipoproteins Time Frame: 52 Weeks	Total cholesterol (mg/dL), Triglycerides (TG) (mg/dL), high density lipoprotein cholesterol (HDL-C) (mg/dL), Non-HDL-C (mg/dL), and low-density lipoprotein cholesterol (LDL-C) (mg/dL).	52 Weeks
Change from baseline in markers of glycemic control: HbA1c (%) Time Frame: 52 Weeks		52 Weeks
Change from baseline in markers of glycemic control: adiponectin (mg/L) Time Frame: 52 Weeks		52 Weeks
Change from baseline in markers of liver injury Time Frame: 52 Weeks	Alanine aminotransferase (ALT) (U/L), aspartate aminotransferase (AST) (U/L), and gamma glutamyl transferase (GGT) (U/L).	52 Weeks
Change from baseline in markers of liver injury: uric acid (mg/dL) Time Frame: 52 Weeks		52 Weeks
Change from baseline in body weight (kg) Time Frame: 52 Weeks		52 Weeks
Percentage of participants with reduction in enhanced liver fibrosis (ELF) score by ≥ 0.5 and reduction in liver stiffness measurement (LSM) by ≥ 30% Time Frame: 52 Weeks		52 Weeks
Change from baseline in non-invasive marker ELF score Time Frame: 52 Weeks	ELF scale of 6.7 to 9.8 where higher scores indicative of increased fibrosis.	52 Weeks
Percentage of participants with a reduction in ELF score by ≥ 0.5 Time Frame: 52 Weeks		52 Weeks
Percentage of participants with a reduction in LSM by ≥ 30% Time Frame: 52 Weeks		52 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akero Therapeutics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2023

Primary Completion (Actual)

March 3, 2026

Study Completion (Estimated)

June 19, 2026

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

November 29, 2023

First Posted (Actual)

December 8, 2023

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

AK-US-001-0107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on NASH/MASH

Fondazione Epatocentro Ticino

Recruiting

Prospective Cohort and Biobank of Patients With Nonalcoholic Fatty Liver Disease (NAFLD Cohort)

NAFLD | NASH/MASH | MASH

Switzerland
Consorcio Centro de Investigación Biomédica en...
Hospital General Universitario Gregorio Marañon; Universidad Complutense de... and other collaborators

Not yet recruiting

Exercise for an Aging Liver (EXALIVER) (EXALIVER)

Liver Fibrosis/NASH | MASH - Metabolic Dysfunction-Associated Steatohepatitis | MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Spain
Haisco Pharmaceutical Group Co., Ltd.

Not yet recruiting

A Phase 3 Study Evaluating the Safety and Efficacy of HSK31679 in Patients With MASH

NASH (Non-Alcoholic Steatohepatitis) | MASH - Metabolic Dysfunction-Associated Steatohepatitis
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruiting

Digoxin In NASH (CODIN) (CODIN)

NAFLD | NASH | Fatty Liver Disease | Fatty Liver Disease, Nonalcoholic | MASLD | MASH With Fibrosis | MASH - Metabolic Dysfunction-Associated Steatohepatitis | Mash

United States
Aligos Therapeutics

Completed

ALG-055009 in Non-cirrhotic Adults With MASH (HERALD) (HERALD)

Nonalcoholic Steatohepatitis | NASH | MASH | Metabolic Dysfunction-Associated Steatohepatitis

United States
Corcept Therapeutics

Recruiting

Evaluating the Pharmacokinetics and Safety of Miricorilant

Nonalcoholic Steatohepatitis (NASH) | Non-alcoholic Fatty Liver Disease (NAFLD) | Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) | Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

United States
Corcept Therapeutics

Active, not recruiting

A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)

Nonalcoholic Steatohepatitis (NASH) | Metabolic Dysfunction-associated Steatohepatitis (MASH)

United States, India, Puerto Rico
Akero Therapeutics, Inc

Recruiting

A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

NASH - Nonalcoholic Steatohepatitis | MASH - Metabolic Dysfunction-Associated Steatohepatitis

United States, Canada, Puerto Rico, Australia, India, France, Italy, Spain, Israel, Switzerland, Germany, United Kingdom, Argentina, Mexico, Brazil, Chile, South Korea, Turkey (Türkiye), Poland
Akero Therapeutics, Inc

Recruiting

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

NASH With Fibrosis | MASH With Fibrosis

United States, Canada, Puerto Rico, Australia, India, France, Italy, Spain, Israel, Switzerland, United Kingdom, Argentina, Germany, Taiwan, South Korea, Turkey (Türkiye), Mexico, Poland
Cascade Pharmaceuticals, Inc

Completed

Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS060380 in Healthy and Elevated LDL-C Subjects

MASH

China

Clinical Trials on Placebo

Galderma R&D

Completed

Effect of CD07805/47 Gel in Rosacea Flushing

Rosacea

Germany
SamA Pharmaceutical Co., Ltd

Unknown

Clinical Trials to Assess the Efficacy and Safety of HLIM

Acute Bronchitis | Acute Upper Respiratory Tract Infection

Korea, Republic of
National Institute on Drug Abuse (NIDA)

Completed

Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics

Cannabis Use

United States
Akeso

Not yet recruiting

A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis

Atopic Dermatitis

China
AstraZeneca
Parexel; Spandauer Damm 130; 14050; Berlin, Germany

Completed

Assessment of the Safety, Tolerability and Pharmacodynamics After Administration of One Dose of AZD8601 to Male Patients With Type II Diabetes Mellitus (T2DM)

Male Subjects With Type II Diabetes (T2DM)

Germany
Heptares Therapeutics Limited

Completed

Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects (HTL0018318)

Pharmacokinetics | Safety Issues

United Kingdom
GlaxoSmithKline

Completed

A Clinical Study Assessing Critical Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA® Dry Powder Inhaler, in Comparison to Combinations of Dry Powder Inhalers Used to Provide Triple Therapy, in Patients With Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive

United Kingdom, Netherlands
Shijiazhuang Yiling Pharmaceutical Co. Ltd
Xuanwu Hospital, Beijing

Completed

Study on the Safety, Tolerance and Pharmacokinetics of Phenlarmide Tablets

Parkinson Disease

China
GlaxoSmithKline

Completed

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects

Infections, Bacterial

United States
West Penn Allegheny Health System

Completed

Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis

Asthma | Allergic Rhinitis

United States

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)

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on NASH/MASH

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations