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Experimental drug aims to reverse liver scarring in NASH cirrhosis

NCT ID NCT05039450

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

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 Results may not be published yet.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

Expanded access (not trials)

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

When the status isn't known

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This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This phase 2b trial tests whether efruxifermin, an experimental drug, can improve liver fibrosis (scarring) without worsening inflammation in people with compensated cirrhosis due to NASH. Participants receive either efruxifermin or a placebo for up to 96 weeks. The main goal is to see if more people on the drug achieve at least a one-stage reduction in fibrosis compared to placebo.

What this could mean

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

Active substance
an experimental drug called efruxifermin
What this could lead to
If successful, this could point toward a treatment that reverses liver scarring in people with advanced NASH cirrhosis, potentially preventing the need for a liver transplant.
What could go wrong
This is an early-phase trial with a modest number of participants, so results may not confirm benefit. The drug may cause side effects or fail to improve fibrosis in a larger population.

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

Study facts

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

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

213 people

The number who actually took part.

Started

Jul 2021

Finished

Aug 2025

Lead sponsor

A company

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

Who can take part

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

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

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

Show the full entry requirements

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

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

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

As listed by the trial registrant

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

NASH - nonalcoholic steatohepatitis

Contacts and locations

Locations

  • Akero Clinical Study Site

    Chandler, Arizona, 85224, United States

  • Akero Clinical Study Site

    Glendale, Arizona, 85306, United States

  • Akero Clinical Study Site

    Tucson, Arizona, 85711, United States

  • Akero Clinical Study Site

    Tucson, Arizona, 85712, United States

  • Akero Clinical Study Site

    North Little Rock, Arkansas, 72117, United States

  • Akero Clinical Study Site

    Fresno, California, 93720, United States

  • Akero Clinical Study Site

    Long Beach, California, 90808, United States

  • Akero Clinical Study Site

    Los Angeles, California, 90036, United States

  • Akero Clinical Study Site

    Pasadena, California, 91105, United States

  • Akero Clinical Study Site

    Englewood, Colorado, 80113, United States

  • Akero Clinical Study Site

    Clearwater, Florida, 33761, United States

  • Akero Clinical Study Site

    Fort Myers, Florida, 33907, United States

  • Akero Clinical Study Site

    Fort Myers, Florida, 33912, United States

  • Akero Clinical Study Site

    Hialeah Gardens, Florida, 33016, United States

  • Akero Clinical Study Site

    Lakewood Rch, Florida, 34211, United States

  • Akero Clinical Study Site

    Miami Lakes, Florida, 33016, United States

  • Akero Clinical Study Site

    Ocala, Florida, 34471, United States

  • Akero Clinical Study Site

    Sarasota, Florida, 34240, United States

  • Akero Clinical Study Site

    South Bend, Indiana, 46635, United States

  • Akero Clinical Study Site

    Topeka, Kansas, 66606, United States

  • Akero Clinical Study Site

    Bastrop, Louisiana, 71220, United States

  • Akero Clinical Study Site

    Marrero, Louisiana, 70072, United States

  • Akero Clinical Study Site

    Las Vegas, Nevada, 89109, United States

  • Akero Clinical Study Site

    Concord, North Carolina, 28027, United States

  • Akero Clinical Study Site

    Fayetteville, North Carolina, 28304, United States

  • Akero Clinical Study Site

    Morehead City, North Carolina, 28557, United States

  • Akero Clinical Study Site

    Springboro, Ohio, 45066, United States

  • Akero Clinical Study Site

    Westlake, Ohio, 44145, United States

  • Akero Clinical Study Site

    Greenville, South Carolina, 29605, United States

  • Akero Clinical Study Site

    Greenwood, South Carolina, 29646, United States

  • Akero Clinical Study Site

    Summerville, South Carolina, 29485, United States

  • Akero Clinical Study Site

    Nashville, Tennessee, 37211, United States

  • Akero Clinical Study Site

    Austin, Texas, 78746, United States

  • Akero Clinical Study Site

    Dallas, Texas, 75246, United States

  • Akero Clinical Study Site

    Edinburg, Texas, 78504, United States

  • Akero Clinical Study Site

    Edinburg, Texas, 78539, United States

  • Akero Clinical Study Site

    Fort Worth, Texas, 75044, United States

  • Akero Clinical Study Site

    Fort Worth, Texas, 76104, United States

  • Akero Clinical Study Site

    Houston, Texas, 77030, United States

  • Akero Clinical Study Site

    Houston, Texas, 77079, United States

  • Akero Clinical Study Site

    San Antonio, Texas, 78215, United States

  • Akero Clinical Study Site

    Waco, Texas, 76710, United States

  • Akero Clinical Study Site

    Webster, Texas, 77598, United States

  • Akero Clinical Study Site

    Wichita Falls, Texas, 76301, United States

  • Akero Clinical Study Site

    Ogden, Utah, 84405, United States

  • Akero Clinical Study Site

    Richmond, Virginia, 23298, United States

  • Akero Clinical Study Site

    Mexico City, Mexico

  • Akero Clinical Study Site

    Monterrey, Mexico

  • Akero Clinical Study Site

    San Juan, 00927, Puerto Rico

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