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New drug shows promise for liver disease in early trial

NCT ID NCT05569759

Disease control Sponsor: Kezar Life Sciences, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called zetomipzomib in 24 adults with autoimmune hepatitis, a condition where the immune system attacks the liver. Participants received either the drug or a placebo along with their usual treatment for 24 weeks, with an option to continue the drug for another 24 weeks. The goal was to see if the drug could improve liver health and reduce the need for steroids, while monitoring for side effects.

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

24 people

The number who actually took part.

Started

May 2023

Finished

Apr 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 years and older

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.

Key Inclusion Criteria for the Double-blind Treatment Period: * Must be aged ≥18 years. * Must have a clinical diagnosis of AIH and signs of active disease despite standard-of-care therapy for ≥3 months or disease flare after experiencing complete remission induced by standard-of-care treatment, including: * Screening ALT values that are 1.25 to 10 times the upper limit of the normal range (ULN) * Liver biopsy results with Ishak score (modified HAI) ≥5/18 indicating active AIH, from a biopsy performed at Screening, or within 6 months prior to Screening * Mild or no hepatic impairment (Child Pugh category A) * Must be willing to use and taper glucocorticoid therapy. * Must be willing to use effective contraception. Key Exclusion Criteria for the Double-blind Treatment Period: * Have a concomitant diagnosis of primary biliary sclerosis, primary sclerosing cholangitis, IgG 4 related cholangitis, drug related AIH (at Screening) or a history of drug-related AIH. * Have clinical evidence of significant unstable or uncontrolled diseases other than the disease under study. * Are receiving oral or injectable immunomodulating treatment for any other autoimmune disease prior to enrollment in the study. Patients who have been using such treatments must follow the specified washout periods. * Have an active infection (eg, acute hepatitis E, cytomegalovirus, or Epstein-Barr virus) requiring systemic therapy with antibiotic, antiviral, or antifungal treatment, or has had any febrile illness within 7 days prior to Day -1. * Have a history of thyroiditis, celiac disease, or other autoimmune disorder known to be associated with transaminitis. * Have liver cirrhosis with significant impairment of liver function (Child Pugh category B or C) or have decompensated cirrhosis. * Patients with histology confirmed coincident non-alcoholic steatohepatitis. Key Inclusion Criteria for the Open-label Extension Period: * Same as Double-blind Treatment Period inclusion criteria, except the following modifications: * ALT value can be normal or, if elevated, in the range of 1.25 to 10 times the upper limit of normal * Must have completed the Double-blind Period study visits through Week 24, including all Week 24 Visit assessments. * Must be willing to maintain glucocorticoid therapy or continue to taper glucocorticoid therapy. Key Exclusion Criteria for the Open-label Extension Period: • Same as Double-blind Treatment Period except no need to re-test for HIV, HBV, HCV, and TB.

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Conditions

The condition(s) this trial relates to.

autoimmune hepatitis

As listed by the trial registrant

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

Autoimmune hepatitis

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • California Pacific Medical Center

    San Francisco, California, 94109, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Keck School of Medicine of USC

    Los Angeles, California, 90033, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

  • New York University Langone Health/Grossman School of Medicine

    New York, New York, 10016, United States

  • Northwell Health Center for Liver Disease and Transplantation

    Manhasset, New York, 11030, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Rush University

    Chicago, Illinois, 60612, United States

  • Stanford Medicine

    Redwood City, California, 94063, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of California, Los Angeles

    Los Angeles, California, 90095, United States

  • University of California, San Francisco

    San Francisco, California, 94132, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Yale University

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.