NASH/MASHPhase 3NCT06161571
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)
A Phase 3 study testing Efruxifermin in people with NASH/MASH and NAFLD/MASLD, run by Akero Therapeutics, Inc at 211 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NASH/MASH, NAFLD/MASLD
- What is being tested?
- Efruxifermin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 211 sitesin 13 countries
- Study dates
- 10 Nov 2023to 19 Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
211 sites in 13 countries.
211 sites in 13 countries
United States139 sites
Akero Clinical Study Site
Amarillo, Texas, 79106
Akero Clinical Study Site
Austin, Texas, 78745
Akero Clinical Study Site
Austin, Texas, 78757
Akero Clinical Study Site
Baltimore, Maryland, 21202
Akero Clinical Study Site
Bastrop, Louisiana, 71220
Akero Clinical Study Site
Bellaire, Texas, 77401
Akero Clinical Study Site
Birmingham, Alabama, 35209
Akero Clinical Study Site
Bradenton, Florida, 34208
Akero Clinical Study Site
Brandon, Florida, 33511
Akero Clinical Study Site
Brick, New Jersey, 08724
Akero Clinical Study Site
Brownsville, Texas, 78520
Akero Clinical Study Site
Chandler, Arizona, 85224
Akero Clinical Study Site
Chapel Hill, North Carolina, 27516
Akero Clinical Study Site
Charlotte, North Carolina, 28204
Akero Clinical Study Site
Chattanooga, Tennessee, 37421
Akero Clinical Study Site
Chula Vista, California, 91910
Akero Clinical Study Site
Clarksville, Tennessee, 37040
Akero Clinical Study Site
Columbia, Missouri, 65201
Akero Clinical Study Site
Columbia, South Carolina, 29204
Akero Clinical Study Site
Columbus, Georgia, 31904
Akero Clinical Study Site
Columbus, Ohio, 43213
Akero Clinical Study Site
Conway, Arkansas, 72032
Akero Clinical Study Site
Coronado, California, 92118
Akero Clinical Study Site
Corpus Christi, Texas, 78404
Akero Clinical Study Site
Covington, Louisiana, 70433
Akero Clinical Study Site
Cypress, California, 90630
Akero Clinical Study Site
Dallas, Texas, 75203
Akero Clinical Study Site
Dallas, Texas, 75230
Akero Clinical Study Site
Dallas, Texas, 75234
Akero Clinical Study Site
Dallas, Texas, 75390
Akero Clinical Study Site
Dayton, Ohio, 45414
Akero Clinical Study Site
Edinburg, Texas, 78539
Akero Clinical Study Site
Englewood, Colorado, 80113
Akero Clinical Study Site
Falls Church, Virginia, 22042-3300
Akero Clinical Study Site
Fayetteville, North Carolina, 28304
Akero Clinical Study Site
Flagstaff, Arizona, 86001
Akero Clinical Study Site
Florham Park, New Jersey, 07932
Akero Clinical Study Site
Fort Myers, Florida, 33912
Akero Clinical Study Site
Fort Worth, Texas, 76104
Akero Clinical Study Site
Gainesville, Florida, 32610
Akero Clinical Study Site
Gainesville, Georgia, 30501
Akero Clinical Study Site
Glen Burnie, Maryland, 21061
Akero Clinical Study Site
Greenbelt, Maryland, 20770
Akero Clinical Study Site
Hermitage, Tennessee, 37076
Akero Clinical Study Site
Hialeah Gardens, Florida, 33016
Akero Clinical Study Site
Houma, Louisiana, 70363
Akero Clinical Study Site
Houston, Texas, 77030
Akero Clinical Study Site
Houston, Texas, 77079
Akero Clinical Study Site
Houston, Texas, 77084
Akero Clinical Study Site
Inglewood, California, 90301
Akero Clinical Study Site
Inverness, Florida, 34452
Akero Clinical Study Site
Jacksonville, Florida, 32256
Akero Clinical Study Site
Jonesboro, Arkansas, 72401
Akero Clinical Study Site
Kansas City, Missouri, 64131
Akero Clinical Study Site
La Mesa, California, 91942
Akero Clinical Study Site
Lady Lake, Florida, 32159
Akero Clinical Study Site
Lakewood Rch, Florida, 34211
Akero Clinical Study Site
Lancaster, California, 93534
Akero Clinical Study Site
Largo, Florida, 33777
Akero Clinical Study Site
Las Vegas, Nevada, 89106
Akero Clinical Study Site
Las Vegas, Nevada, 89109
Akero Clinical Study Site
Lewisville, Texas, 75057
Akero Clinical Study Site
Little Rock, Arkansas, 72205
Akero Clinical Study Site
Los Angeles, California, 90036-4669
Akero Clinical Study Site
Los Angeles, California, 90057
Akero Clinical Study Site
Maitland, Florida, 32751
Akero Clinical Study Site
Marietta, Georgia, 30060
Akero Clinical Study Site
Marrero, Louisiana, 70072
Akero Clinical Study Site
McAllen, Texas, 78504
Akero Clinical Study Site
Metairie, Louisiana, 70006
Akero Clinical Study Site
Miami, Florida, 33136
Akero Clinical Study Site
Miami Lakes, Florida, 33016
Akero Clinical Study Site
Morehead City, North Carolina, 28557
Akero Clinical Study Site
Naples, Florida, 34102
Akero Clinical Study Site
Nashville, Tennessee, 37211
Akero Clinical Study Site
New Bern, North Carolina, 28562
Akero Clinical Study Site
New Orleans, Louisiana, 70121
Akero Clinical Study Site
New York, New York, 10029
Akero Clinical Study Site
New York, New York, 10033
Akero Clinical Study Site
Norfolk, Virginia, 23502
Akero Clinical Study Site
North Little Rock, Arkansas, 72117
Akero Clinical Study Site
Ocala, Florida, 34471
Akero Clinical Study Site
Ogden, Utah, 84405
Akero Clinical Study Site
Palm Springs, California, 92262
Akero Clinical Study Site
Peoria, Arizona, 85381
Akero Clinical Study Site
Philadelphia, Pennsylvania, 19104
Akero Clinical Study Site
Philadelphia, Pennsylvania, 19107
Akero Clinical Study Site
Pittsburgh, Pennsylvania, 15213
Akero Clinical Study Site
Port Orange, Florida, 32127
Akero Clinical Study Site
Raleigh, North Carolina, 27612
Akero Clinical Study Site
Reno, Nevada, 89511
Akero Clinical Study Site
Richmond, Virginia, 23226
Akero Clinical Study Site
Richmond, Virginia, 23236
Akero Clinical Study Site
Richmond, Virginia, 23249
Akero Clinical Study Site
Richmond, Virginia, 23298
Akero Clinical Study Site
Roanoke, Virginia, 24014
Akero Clinical Study Site
Salt Lake City, Utah, 84117
Akero Clinical Study Site
San Antonio, Texas, 78215
Akero Clinical Study Site
San Antonio, Texas, 78222
Akero Clinical Study Site
San Antonio, Texas, 78229
Akero Clinical Study Site
San Antonio, Texas, 78258
Akero Clinical Study Site
San Diego, California, 92120
Akero Clinical Study Site
San Diego, California, 92123
Akero Clinical Study Site
San Francisco, California, 94115
Akero Clinical Study Site
San Marcos, Texas, 78666-7502
Akero Clinical Study Site
Sandy City, Utah, 84092
Akero Clinical Study Site
Santa Fe, New Mexico, 87505
Akero Clinical Study Site
Santa Maria, California, 93458
Akero Clinical Study Site
Sarasota, Florida, 34240
Akero Clinical Study Site
Seattle, Washington, 98105
Akero Clinical Study Site
Shreveport, Louisiana, 71103
Akero Clinical Study Site
Somers Point, New Jersey, 08244
Akero Clinical Study Site
South Bend, Indiana, 46635
Akero Clinical Study Site
South Dartmouth, Massachusetts, 02747
Akero Clinical Study Site
South Ogden, Utah, 84405
Akero Clinical Study Site
Southfield, Michigan, 48075
Akero Clinical Study Site
Sparta, New Jersey, 07871
Akero Clinical Study Site
Spokane, Washington, 99218
Akero Clinical Study Site
Springboro, Ohio, 45066
Akero Clinical Study Site
Statesville, North Carolina, 28625
Akero Clinical Study Site
Suffolk, Virginia, 23435
Akero Clinical Study Site
Summerville, South Carolina, 29485
Akero Clinical Study Site
The Villages, Florida, 32162
Akero Clinical Study Site
Topeka, Kansas, 66606
Akero Clinical Study Site
Tucson, Arizona, 85712
Akero Clinical Study Site
Tucson, Arizona, 85715
Akero Clinical Study Site
Venice, Florida, 34285
Akero Clinical Study Site
Viera, Florida, 32940
Akero Clinical Study Site
Waco, Texas, 76710
Akero Clinical Study Site
Webster, Texas, 77598
Akero Clinical Study Site
West Des Moines, Iowa, 50265
Akero Clinical Study Site
West Palm Beach, Florida, 33401
Akero Clinical Study Site
Westlake, Ohio, 44145
Akero Clinical Study Site
Wichita, Kansas, 67205
Akero Clinical Study Site
Wichita Falls, Texas, 76301
Akero Clinical Study Site
Winter Park, Florida, 32789
Akero Clinical Study Site
Winter Park, Florida, 32792
Akero Clinical Study Site
Wyoming, Michigan, 49519
Akero Clinical Study Site
Ypsilanti, Michigan, 48197
India16 sites
Akero Clinical Study Site
Chandigarh, Punjab, 160012
Akero Clinical Study Site
Coimbatore, Tamil Nadu, 641005
Akero Clinical Study Site
Dahegaon, Maharashtra, 441108
Akero Clinical Study Site
Hyderabad, Telangana, 500 004
Akero Clinical Study Site
Jaipur, Rajasthan, 302001
Akero Clinical Study Site
Kolkata, West Bengal, 700020
Akero Clinical Study Site
Kolkata, West Bengal, 700073
Akero Clinical Study Site
Kolkata, West Bengal, 700150
Akero Clinical Study Site
Mumbai, Maharashtra, 400012
Akero Clinical Study Site
Nagpur, Maharashtra, 440010
Akero Clinical Study Site
New Delhi, National Capital Territory of Delhi, 110029
Akero Clinical Study Site
Pune, Maharashtra, 412201
Akero Clinical Study Site
Surat, Gujarat, 395002
Akero Clinical Study Site
Thiruvananthapuram, Kerala, 695011
Akero Clinical Study Site
Vadodara, Gujarat, 390007
Akero Clinical Study Site
Varanasi, Uttar Pradesh, 221005
Israel10 sites
Akero Clinical Study Site
Afula, Northern District, 1834111
Akero Clinical Study Site
Haifa, Haifa District, 3109601
Akero Clinical Study Site
Haifa, Haifa District, 3436212
Akero Clinical Study Site
Jerusalem, 9103102
Akero Clinical Study Site
Jerusalem, 9112001
Akero Clinical Study Site
Nahariya, Northern District, 22100
Akero Clinical Study Site
Nazareth, Northern District, 16234
Akero Clinical Study Site
Petah Tikva, Central District, 4941492
Akero Clinical Study Site
Ramat Gan, Central District, 5265601
Akero Clinical Study Site
Tel Aviv, 6423906
Australia9 sites
Akero Clinical Study Site
Adelaide, South Australia, 5000
Akero Clinical Study Site
Broadmeadow, New South Wales, 2292
Akero Clinical Study Site
Clayton, Victoria, 3168
Akero Clinical Study Site
Epping, Victoria, 3076
Akero Clinical Study Site
Heidelberg, Victoria, 3084
Akero Clinical Study Site
Melbourne, Victoria, 3004
Akero Clinical Study Site
Murdoch, Western Australia, 6150
Akero Clinical Study Site
Perth, Western Australia, 6000
Akero Clinical Study Site
Westmead, New South Wales, 2145
South Korea7 sites
Akero Clinical Study Site
Daegu, Daegu Gwang'yeogsi, 41944
Akero Clinical Study Site
Daegu, Gyeongsangbuk-do, 42601
Akero Clinical Study Site
Goyang-si, Gyeonggi-do, 1232
Akero Clinical Study Site
Incheon, Gyeonggi-do, 22332
Akero Clinical Study Site
Seongnam-si, Gyeonggi-do, 13496
Akero Clinical Study Site
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 04763
Akero Clinical Study Site
Seoul, Seoul Teugbyeolsi, 03080
United Kingdom7 sites
Akero Clinical Study Site
Liverpool, England, L9 7AL
Akero Clinical Study Site
London, England, E1 1BB
Akero Clinical Study Site
London, England, NW3 2QG
Akero Clinical Study Site
London, England, SE5 9RS
Akero Clinical Study Site
London, England, SW10 9NH
Akero Clinical Study Site
London, England, W2 1NY
Akero Clinical Study Site
Newcastle upon Tyne, England, NE7 7DN
Canada5 sites
Akero Clinical Study Site
Edmonton, Alberta, T6G 2X8
Akero Clinical Study Site
Hamilton, Ontario, L8S 4K1
Akero Clinical Study Site
Terrebonne, Quebec, J7B6B7
Akero Clinical Study Site
Toronto, Ontario, M6H 3M1
Akero Clinical Study Site
Vaughan, Ontario, L4L 4Y7
Argentina4 sites
Akero Clinical Study Site
Buenos Aires, Distrito Federal, C1125ABE
Akero Clinical Study Site
Buenos Aires, C1118AAT
Akero Clinical Study Site
Buenos Aires, C1280AEB
Akero Clinical Study Site
Ramos Mejía, Buenos Aires, B1704ETD
Taiwan4 sites
Akero Clinical Study Site
Changhua, Changhua, 500
Akero Clinical Study Site
Taichung, Taichung, 40447
Akero Clinical Study Site
Tainan, Tainan, 73657
Akero Clinical Study Site
Taipei, 10048
Turkey (Türkiye)4 sites
Akero Clinical Study Site
Bornova, İzmir, 35100
Akero Clinical Study Site
Bursa, 16059
Akero Clinical Study Site
Rize, 53020
Akero Clinical Study Site
Yenimahalle, Ankara, 06500
Switzerland3 sites
Akero Clinical Study Site
Bern, 3010
Akero Clinical Study Site
Olten, Canton of Solothurn, 4600
Akero Clinical Study Site
Sankt Gallen, 9007
Puerto Rico2 sites
Akero Clinical Study Site
Manati, 00674
Akero Clinical Study Site
San Juan, 00927
About this study
Official title: 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.
- Conditions
- NASH/MASH, NAFLD/MASLD
- Being tested
- Efruxifermin, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfruxiferminDrug
Administered by subcutaneous (SC) injection
PlaceboDrug
Administered by SC injection
| Study group | Role | What they receive |
|---|---|---|
| EFX 50 mg | Experimental | Not described Receives: Drug: Efruxifermin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| EFX 50 mg (Open-Label Rollover) | Experimental | Not described Receives: Drug: Efruxifermin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%
Measured: 52 Weeks
Change from baseline in non-invasive marker ELF score
ELF scale of 6.7 to 9.8 where higher scores indicative of increased fibrosis.
Measured: 52 Weeks
Change from baseline in non-invasive marker pro-peptide of type 3 procollagen (Pro-C3)
Measured: 52 Weeks
Change from baseline in non-invasive marker liver stiffness assessed by transient elastography (kPa, CAP)
Measured: 52 Weeks
Percentage of participants with a reduction in ELF score by ≥ 0.5
Measured: 52 Weeks
Percentage of participants with a reduction in LSM by ≥ 30%
Measured: 52 Weeks
Change from baseline in lipoproteins
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).
Measured: 52 Weeks
Change from baseline in markers of glycemic control: HbA1c (%)
Measured: 52 Weeks
Change from baseline in markers of glycemic control: adiponectin (mg/L)
Measured: 52 Weeks
Change from baseline in markers of liver injury
Alanine aminotransferase (ALT) (U/L), aspartate aminotransferase (AST) (U/L), and gamma glutamyl transferase (GGT) (U/L).
Measured: 52 Weeks
Change from baseline in markers of liver injury: uric acid (mg/dL)
Measured: 52 Weeks
Change from baseline in body weight (kg)
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start10 Nov 2023
- Primary completion3 Mar 2026
- Study completion19 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH/MASHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akero Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161571
- Sponsor's protocol ID
- AK-US-001-0107
- Status last verified
- Apr 2026
- First submitted
- 22 Nov 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06161571
- Acronym / sponsor ID
- AK-US-001-0107
- Conditions
- NASH/MASH, NAFLD/MASLD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Akero Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 19 Jun 2026 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EFX 50 mg | Experimental | Drug: Efruxifermin |
| Placebo | Placebo comparator | Drug: Placebo |
| EFX 50 mg (Open-Label Rollover) | Experimental | Drug: Efruxifermin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EfruxiferminAdministered by subcutaneous (SC) injection | Drug | EFX 50 mg, EFX 50 mg (Open-Label Rollover) |
| PlaceboAdministered by SC injection | Drug | Placebo |
Primary outcome
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.
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.
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.
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.
12 secondary outcomes
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
Change from baseline in non-invasive marker ELF score
Time frame: 52 Weeks
Change from baseline in non-invasive marker pro-peptide of type 3 procollagen (Pro-C3)
Time frame: 52 Weeks
Change from baseline in non-invasive marker liver stiffness assessed by transient elastography (kPa, CAP)
Time frame: 52 Weeks
Percentage of participants with a reduction in ELF score by ≥ 0.5
Time frame: 52 Weeks
Percentage of participants with a reduction in LSM by ≥ 30%
Time frame: 52 Weeks
Change from baseline in lipoproteins
Time frame: 52 Weeks
Change from baseline in markers of glycemic control: HbA1c (%)
Time frame: 52 Weeks
Change from baseline in markers of glycemic control: adiponectin (mg/L)
Time frame: 52 Weeks
Change from baseline in markers of liver injury
Time frame: 52 Weeks
Change from baseline in markers of liver injury: uric acid (mg/dL)
Time frame: 52 Weeks
Change from baseline in body weight (kg)
Time frame: 52 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for NASH/MASH
RecruitingPhase 3
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
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
RecruitingPhase 3
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
Metabolic Dysfunction Associated Steatohepatitis (MASH), Liver Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
211 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Efruxifermin in people with NASH/MASH and NAFLD/MASLD, run by Akero Therapeutics, Inc at 211 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 211 sites in United States, India, Israel, Australia, South Korea and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of exposure (time frame: 52 Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.