NASH - Nonalcoholic SteatohepatitisPhase 2NCT05039450

A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)

A Phase 2 study testing EFX in people with NASH - Nonalcoholic Steatohepatitis, run by Akero Therapeutics, Inc at 49 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven F4 compensated NASH. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: NASH - Nonalcoholic Steatohepatitis
What is being tested?: EFX
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 213 participants
Where: 49 sitesin 3 countries
Study dates: 30 Jul 2021to 28 Aug 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and non-pregnant, non-lactating females between 18-75 years of age inclusive, based on the date of signing informed consent.
Main Study Only: Previous history or presence of Type 2 diabetes or 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose).
Main Study Only: Biopsy-proven compensated cirrhosis due to NASH.
Cohort D Only: Diagnosis of type 2 diabetes
Cohort D Only: Use of GLP-1R agonist for at least 90 days
Cohort D Only: Biopsy-proven liver fibrosis stages 1, 2, or 3

Who cannot join

Main Study Only: Weight loss > 10% in the 90 days prior to screening until randomization or from the time of collection of the liver biopsy used to assess subject eligibility until randomization, whichever is longer.
Type 1 diabetes or uncontrolled Type 2 diabetes
Cohort D Only: Weight loss > 5% in the 90 days prior to screening
Cohort D Only: Presence of cirrhosis on liver biopsy
Other inclusion and exclusion criteria may apply

Trial locations and contacts

49 sites in 3 countries.

Country

City, postcode or hospital

49 sites in 3 countries

United States46 sites

Akero Clinical Study Site
Austin, Texas, 78746
Akero Clinical Study Site
Bastrop, Louisiana, 71220
Akero Clinical Study Site
Chandler, Arizona, 85224
Akero Clinical Study Site
Clearwater, Florida, 33761
Akero Clinical Study Site
Concord, North Carolina, 28027
Akero Clinical Study Site
Dallas, Texas, 75246
Akero Clinical Study Site
Edinburg, Texas, 78504
Akero Clinical Study Site
Edinburg, Texas, 78539
Akero Clinical Study Site
Englewood, Colorado, 80113
Akero Clinical Study Site
Fayetteville, North Carolina, 28304
Akero Clinical Study Site
Fort Myers, Florida, 33907
Akero Clinical Study Site
Fort Myers, Florida, 33912
Akero Clinical Study Site
Fort Worth, Texas, 75044
Akero Clinical Study Site
Fort Worth, Texas, 76104
Akero Clinical Study Site
Fresno, California, 93720
Akero Clinical Study Site
Glendale, Arizona, 85306
Akero Clinical Study Site
Greenville, South Carolina, 29605
Akero Clinical Study Site
Greenwood, South Carolina, 29646
Akero Clinical Study Site
Hialeah Gardens, Florida, 33016
Akero Clinical Study Site
Houston, Texas, 77030
Akero Clinical Study Site
Houston, Texas, 77079
Akero Clinical Study Site
Lakewood Rch, Florida, 34211
Akero Clinical Study Site
Las Vegas, Nevada, 89109
Akero Clinical Study Site
Long Beach, California, 90808
Akero Clinical Study Site
Los Angeles, California, 90036
Akero Clinical Study Site
Marrero, Louisiana, 70072
Akero Clinical Study Site
Miami Lakes, Florida, 33016
Akero Clinical Study Site
Morehead City, North Carolina, 28557
Akero Clinical Study Site
Nashville, Tennessee, 37211
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
Pasadena, California, 91105
Akero Clinical Study Site
Richmond, Virginia, 23298
Akero Clinical Study Site
San Antonio, Texas, 78215
Akero Clinical Study Site
Sarasota, Florida, 34240
Akero Clinical Study Site
South Bend, Indiana, 46635
Akero Clinical Study Site
Springboro, Ohio, 45066
Akero Clinical Study Site
Summerville, South Carolina, 29485
Akero Clinical Study Site
Topeka, Kansas, 66606
Akero Clinical Study Site
Tucson, Arizona, 85711
Akero Clinical Study Site
Tucson, Arizona, 85712
Akero Clinical Study Site
Waco, Texas, 76710
Akero Clinical Study Site
Webster, Texas, 77598
Akero Clinical Study Site
Westlake, Ohio, 44145
Akero Clinical Study Site
Wichita Falls, Texas, 76301

Other trials in United States

Mexico2 sites

Akero Clinical Study Site
Mexico City
Akero Clinical Study Site
Monterrey

Other trials in Mexico

Puerto Rico1 site

Akero Clinical Study Site
San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven F4 compensated NASH.

Conditions: NASH - Nonalcoholic Steatohepatitis
Being tested: EFX, 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.

EFXDrug
Investigational drug, Efruxifermin
PlaceboDrug
Placebo

Study groups in NCT05039450
Study group	Role	What they receive
EFX 28 mg (Main Study)	Experimental	Not described Receives: Drug: EFX
EFX 50 mg (Main Study)	Experimental	Not described Receives: Drug: EFX
Placebo (Main Study)	Placebo comparator	Not described Receives: Drug: Placebo
EFX 50 mg (Cohort D)	Experimental	Not described Receives: Drug: EFX
Placebo (Cohort D)	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Main: Change From Baseline in Fibrosis With no Worsening Steatohepatitis Assessed by NASH CRN System
Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 36. No worsening of steatohepatitis was defined as no increase in score for any of the 3 components of NAS. The evaluation of the NAS endpoint was calculated using the following 3 categorical features: steatosis [0-3], lobular inflammation [0-3], and hepatocellular ballooning [0-2]. NAS was derived as the unweighted sum of steatosis, lobular inflammation, and hepatocellular ballooning scores.
Measured: Week 36

Secondary outcomes (17)

Main: Resolution of NASH Assessed by the NASH CRN System
Proportion of subjects who achieve NASH resolution (defined as a NAS of 0-1 for inflammation and 0 for ballooning) as determined by the NASH CRN criteria at Week 36 and Week 96.
Measured: Week 36, Week 96
Main: Fibrosis Improvement and Resolution of NASH Assessed by the NASH CRN System
Proportion of subjects who achieve NASH resolution (defined as a NAS of 0-1 for inflammation and 0 for ballooning) and ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) at Week 36 and Week 96
Measured: Week 36, Week 96
Main: Change From Baseline in Fibrosis With no Worsening of Steatohepatitis Assessed by the NASH CRN System
Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 96
Measured: Week 96
Main: Change From Baseline in Fibrosis by NASH CRN System
Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) at Week 36 and Week 96
Measured: Week 36, Week 96
Main: Change From Baseline in S-Pro-C3
Change from baseline in Serum Pro-C3 (N-terminal type III collagen propeptide), a biomarker of type III collagen formation reflecting fibrogenesis, measured in ug/L.
Measured: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Enhanced Liver Fibrosis (ELF) Score
ELF score is a composite serum biomarker score derived from HA, PIIINP, and TIMP-1 concentrations. Scores range approximately from 6 to 16, with higher scores indicating greater liver fibrosis severity.
Measured: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Liver Stiffness Assessed by Liver Elastography (kPa)
Change from baseline in liver stiffness assessed by liver elastography (kPa)
Measured: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Lipoproteins
Change from baseline in Triglycerides (mg/dL), total cholesterol (mg/dL), high-density lipoprotein (HDL-C) (mg/dL), non-HDL-C (mg/dL), and low-density lipoprotein (LDL-C) (mg/dL)
Measured: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in HbA1c (%)
Glycated hemoglobin (HbA1c), expressed as a percentage, reflects average blood glucose levels over approximately 2 to 3 months and is used as a measure of glycemic control
Measured: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in C-peptide (ug/L)
C-peptide reflects endogenous insulin secretion and pancreatic beta-cell function. Change from baseline represents the difference between the post-baseline value and the baseline measurement.
Measured: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Adiponectin (mg/L)
Adiponectin is involved in glucose and lipid metabolism and is used as a marker of metabolic status. Change from baseline represents the difference between the post-baseline value and the baseline measurement.
Measured: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Insulin (mIU/L)
Insulin reflects endogenous insulin levels measured after a period of fasting. Change from baseline represents the difference between the post-baseline value and the baseline measurement.
Measured: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in HOMA-IR
HOMA-IR has no fixed upper limit. Values near 1 are typically observed in individuals with normal insulin sensitivity, while progressively higher values indicate increasing insulin resistance. The clinical significance of a given value may vary depending on the population and assay methodology. Change from baseline represents the difference between the post-baseline value and the baseline measurement.
Measured: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Body Weight
Change from baseline in body weight (kg)
Measured: Week 36, Week 48, Week 96
Main: Number of Participants With ADA Against EFX
Detect and measure ADA against EFX
Measured: Through Week 96
Main: To Assess the Safety and Tolerability of EFX
Safety and tolerability will be assessed through the reporting of AEs, clinical laboratory tests, ECGs, ultrasounds, vital sign assessments, and concomitant medication usage
Measured: Through Week 96
Cohort D: To Assess the Safety and Tolerability of EFX Compared to Placebo When Added to an Existing GLP-1R Agonist in Subjects With Type 2 Diabetes and Liver Fibrosis Due to NASH
Safety and tolerability will be assessed through the reporting of AEs, clinical laboratory assessments, ECGs, ultrasounds, vital sign assessments, and concomitant medication usage
Measured: Through Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 202128 Aug 2025

First posted9 Sep 2021
Study start30 Jul 2021
Primary completion15 Dec 2023
Study completion28 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for NASH - Nonalcoholic SteatohepatitisStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 213 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05039450
Sponsor's protocol ID: AK-US-001-0103
Status last verified: Jun 2026
First submitted: 29 Jul 2021
Last updated: 21 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Noureddin M, Rinella ME, Chalasani NP, Neff GW, Lucas KJ, Rodriguez ME, Rudraraju M, Patil R, Behling C, Burch M, Chan DC, Tillman EJ, Zari A, de Temple B, Shringarpure R, Jain M, Rolph T, Cheng A, Yale K. Efruxifermin in Compensated Liver Cirrhosis Caused by MASH. N Engl J Med. 2025 Jun 26;392(24):2413-2424. doi: 10.1056/NEJMoa2502242. Epub 2025 May 9.
PubMed 40341827
Harrison SA, Frias JP, Lucas KJ, Reiss G, Neff G, Bollepalli S, Su Y, Chan D, Tillman EJ, Moulton A, de Temple B, Zari A, Shringarpure R, Rolph T, Cheng A, Yale K. Safety and Efficacy of Efruxifermin in Combination With a GLP-1 Receptor Agonist in Patients With NASH/MASH and Type 2 Diabetes in a Randomized Phase 2 Study. Clin Gastroenterol Hepatol. 2025 Jan;23(1):103-113. doi: 10.1016/j.cgh.2024.02.022. Epub 2024 Mar 4.
PubMed 38447814

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
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
Active, not recruiting
Target of Suv420h1/2 in Hepatocytes
NAFLD
Active, not recruitingPhase 3
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NASH - Nonalcoholic Steatohepatitis
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)

All NASH - Nonalcoholic Steatohepatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
ClinicalTrials.gov ID: NCT05039450
Acronym / sponsor ID: AK-US-001-0103
Conditions: NASH - Nonalcoholic Steatohepatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 213 participants (actual)
Lead sponsor: Akero Therapeutics, IncIndustry (pharma, biotech, devices)
Study start: 30 Jul 2021 (actual)
Primary completion: 15 Dec 2023 (actual)
Study completion: 28 Aug 2025 (actual)
First posted: 9 Sep 2021 (actual)
Results: Posted 21 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven F4 compensated NASH.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
EFX 28 mg (Main Study)	Experimental	Drug: EFX
EFX 50 mg (Main Study)	Experimental	Drug: EFX
Placebo (Main Study)	Placebo comparator	Drug: Placebo
EFX 50 mg (Cohort D)	Experimental	Drug: EFX
Placebo (Cohort D)	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 75 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 18-75 years of age inclusive, based on the date of signing informed consent.
Main Study Only: Previous history or presence of Type 2 diabetes or 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose).
Main Study Only: Biopsy-proven compensated cirrhosis due to NASH.
Cohort D Only: Diagnosis of type 2 diabetes
Cohort D Only: Use of GLP-1R agonist for at least 90 days

Key exclusion criteria (5 listed)

Main Study Only: Weight loss > 10% in the 90 days prior to screening until randomization or from the time of collection of the liver biopsy used to assess subject eligibility until randomization, whichever is longer.
Type 1 diabetes or uncontrolled Type 2 diabetes
Cohort D Only: Weight loss > 5% in the 90 days prior to screening
Cohort D Only: Presence of cirrhosis on liver biopsy
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
EFXInvestigational drug, Efruxifermin	Drug	EFX 28 mg (Main Study), EFX 50 mg (Cohort D), EFX 50 mg (Main Study)
PlaceboPlacebo	Drug	Placebo (Cohort D), Placebo (Main Study)

Primary outcome

Main: Change From Baseline in Fibrosis With no Worsening Steatohepatitis Assessed by NASH CRN System
Time frame: Week 36
Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 36. No worsening of steatohepatitis was defined as no increase in score for any of the 3 components of NAS. The evaluation of the NAS endpoint was calculated using the following 3 categorical features: steatosis [0-3], lobular inflammation [0-3], and hepatocellular ballooning [0-2]. NAS was derived as the unweighted sum of steatosis, lobular inflammation, and hepatocellular ballooning scores.

17 secondary outcomes

Main: Resolution of NASH Assessed by the NASH CRN System
Time frame: Week 36, Week 96
Main: Fibrosis Improvement and Resolution of NASH Assessed by the NASH CRN System
Time frame: Week 36, Week 96
Main: Change From Baseline in Fibrosis With no Worsening of Steatohepatitis Assessed by the NASH CRN System
Time frame: Week 96
Main: Change From Baseline in Fibrosis by NASH CRN System
Time frame: Week 36, Week 96
Main: Change From Baseline in S-Pro-C3
Time frame: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Enhanced Liver Fibrosis (ELF) Score
Time frame: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Liver Stiffness Assessed by Liver Elastography (kPa)
Time frame: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Lipoproteins
Time frame: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in HbA1c (%)
Time frame: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in C-peptide (ug/L)
Time frame: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Adiponectin (mg/L)
Time frame: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Insulin (mIU/L)
Time frame: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in HOMA-IR
Time frame: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Body Weight
Time frame: Week 36, Week 48, Week 96
Main: Number of Participants With ADA Against EFX
Time frame: Through Week 96
Main: To Assess the Safety and Tolerability of EFX
Time frame: Through Week 96
Cohort D: To Assess the Safety and Tolerability of EFX Compared to Placebo When Added to an Existing GLP-1R Agonist in Subjects With Type 2 Diabetes and Liver Fibrosis Due to NASH
Time frame: Through Week 12

Results and safety

Results posted to the registry on 21 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo (Main Study)	61	49
EFX 28 mg (Main Study)	58	40
EFX 50 mg (Main Study)	63	47
Placebo (Cohort D)	10	10
EFX 50 mg (Cohort D)	21	19

Primary outcome: Main: Change From Baseline in Fibrosis With no Worsening Steatohepatitis Assessed by NASH CRN System

Time frame: Week 36. Count of participants. Unit: Participants

Measure	Placebo (Main Study) n = 57	EFX 28 mg (Main Study) n = 46	EFX 50 mg (Main Study) n = 51
Responder	8	10	12
Non-responder	49	36	39

Placebo (Main Study) vs EFX 28 mg (Main Study): Point estimate percentage difference: 6.73 (95% CI -8.77 to 22.24), p = 0.3775, Cochran-Mantel-Haenszel
Placebo (Main Study) vs EFX 50 mg (Main Study): Point estimate percentage difference: 7.80 (95% CI -7.45 to 23.04), p = 0.2868, Cochran-Mantel-Haenszel

Population analysed: 36-Week Liver Biopsy Analysis Set

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Main Study)	11 of 61 (18%)	59 of 61 (96.7%)	1 of 61
EFX 28 mg (Main Study)	15 of 57 (26.3%)	56 of 57 (98.2%)	0 of 57
EFX 50 mg (Main Study)	15 of 63 (23.8%)	63 of 63 (100%)	0 of 63
Placebo (Cohort D)	0 of 10 (0%)	7 of 10 (70%)	0 of 10
EFX 50 mg (Cohort D)	2 of 21 (9.5%)	18 of 21 (85.7%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40341827Noureddin M, Rinella ME, Chalasani NP, Neff GW, Lucas KJ, Rodriguez ME, Rudraraju M, Patil R, Behling C, Burch M, Chan DC, Tillman EJ, Zari A, de Temple B, Shringarpure R, Jain M, Rolph T, Cheng A, Yale K. Efruxifermin in Compensated Liver Cirrhosis Caused by MASH. N Engl J Med. 2025 Jun 26;392(24):2413-2424. doi: 10.1056/NEJMoa2502242. Epub 2025 May 9.
Derived from this study: PubMed 38447814Harrison SA, Frias JP, Lucas KJ, Reiss G, Neff G, Bollepalli S, Su Y, Chan D, Tillman EJ, Moulton A, de Temple B, Zari A, Shringarpure R, Rolph T, Cheng A, Yale K. Safety and Efficacy of Efruxifermin in Combination With a GLP-1 Receptor Agonist in Patients With NASH/MASH and Type 2 Diabetes in a Randomized Phase 2 Study. Clin Gastroenterol Hepatol. 2025 Jan;23(1):103-113. doi: 10.1016/j.cgh.2024.02.022. Epub 2024 Mar 4.
Individual participant dataSharing planned: No

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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.

49 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EFX in people with NASH - Nonalcoholic Steatohepatitis, run by Akero Therapeutics, Inc at 49 sites in 3 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 5 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: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Mexico, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Main: Change From Baseline in Fibrosis With no Worsening Steatohepatitis Assessed by NASH CRN System (time frame: Week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05039450, which also lists 2 linked publications.

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 21 Jul 2026.