A Study in Participants With Non-cirrhotic NASH With Fibrosis

Last updated: April 9, 2024
Sponsor: AstraZeneca
Overall Status: Completed

Phase

2

Condition

Scar Tissue

Liver Disease

Treatment

AZD4831

Placebo

Clinical Study ID

NCT05638737
D6581C00001
  • Ages 18-75
  • All Genders

Study Summary

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Participants will be in the trial for up to 24 weeks, including a screening period lasting up to 8 weeks, a 12-week treatment period, and a 4-week safety follow-up period

Participants are not expected to directly benefit from treatment during this trial. Participants will help researchers learn more about and how to develop AZD4831 to treat NASH.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant must be ≥ 18 to ≤ 75 years of age at the time of signing the informedconsent.
  2. Histological confirmed NASH per Clinical Research Network (CRN) criteria as diagnosedby liver biopsy (within 12 months prior screening, participants without historicalbiopsy should be willing to undergo a liver biopsy at screening) fulfilling all of thefollowing criteria:
  • NAS ≥ 4 with a score of ≥ 1 for each component: steatosis, lobular inflammationand ballooning
  • Presence of fibrosis F1, F2-F3
  1. One increased serum ALT measurement (ALT > ULN) at screening, and historical localserum ALT level (> ULN [41 U/L for men and 31 U/L for women] but < 300 U/L) on ≥ 1occasion in the 6 months prior to screening.

Exclusion

Exclusion Criteria:

  1. Liver disease of other etiologies (eg, alcoholic steatohepatitis; drug-induced, viral,or autoimmune hepatitis; primary biliary cirrhosis; primary sclerosing cholangitis;hemochromatosis; alpha 1 antitrypsin deficiency; Wilson's disease).
  2. History of excessive alcohol consumption, defined as an average weekly intake of > 21drinks/week for males or > 14 drinks/week for females. One drink is equivalent to 14 galcohol.
  3. Recent (within 3 months of randomization) use of drugs approved for weight loss (eg,orlistat, bupropion/naltrexone, phentermine-topiramate, phentermine, lorcaserin), aswell as those drugs used off-label.
  4. High dose vitamin E (> 400 IU) unless on a stable dose within 6 months of screening.
  5. Recent (within 6 months of screening) use of therapies associated with development ofNAFLD (eg, systemic corticosteroids, methotrexate, tamoxifen, amiodarone, or long-termuse of tetracyclines).
  6. Recent (within 6 months of screening) use of obeticholic acid or other therapy underinvestigation for NASH.

Study Design

Total Participants: 122
Treatment Group(s): 2
Primary Treatment: AZD4831
Phase: 2
Study Start date:
October 26, 2022
Estimated Completion Date:
April 04, 2024

Study Description

A randomized, double blind, placebo-controlled, parallel-group, multicenter study including a maximum of approximately 90 randomized adult participants with biopsy-proven non-cirrhotic non-alcoholic steatohepatitis (NASH) with fibrosis (NAS ≥ 4, fibrosis stages F1, F2, F3). The study will be conducted at approximately 48 sites across approximately 9 countries.

During screening, the participants will be checked for eligibility and enrolled in the study. Following a 8-week screening period, approximately 90 participants will be randomized in a 1:1 ratio to once daily dosing of AZD4831 or placebo. All participants will be treated once daily with AZD4831 or placebo for 12 weeks. The safety, tolerability, and pharmacodynamics will be evaluated at 12 weeks. This is the first clinical study to test AZD4831 in participants with non-cirrhotic NASH with fibrosis.

Connect with a study center

  • Research Site

    Caba, C1056ABJ
    Argentina

    Site Not Available

  • Research Site

    Ciudad de Buenos Aires, 1280
    Argentina

    Site Not Available

  • Research Site

    Mar del Plata, 7600
    Argentina

    Site Not Available

  • Research Site

    Ramos Mejía, B1704ETD
    Argentina

    Site Not Available

  • Research Site

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Research Site

    Esbjerg, 6700
    Denmark

    Site Not Available

  • Research Site

    Koge, 4600
    Denmark

    Site Not Available

  • Research Site

    København NV, 2400
    Denmark

    Site Not Available

  • Research Site

    Catania, 95100
    Italy

    Site Not Available

  • Research Site

    Foggia, 71100
    Italy

    Site Not Available

  • Research Site

    Milan, 20122
    Italy

    Site Not Available

  • Research Site

    Milano, 20132
    Italy

    Site Not Available

  • Research Site

    Roma, 00168
    Italy

    Site Not Available

  • Research Site

    Rome, 00168
    Italy

    Site Not Available

  • Research Site

    Rozzano, 20089
    Italy

    Site Not Available

  • Research Site

    San Giovanni Rotondo, 71013
    Italy

    Site Not Available

  • Research Site

    Torino, 10126
    Italy

    Site Not Available

  • Research Site

    Ciudad de Mexico, 06700
    Mexico

    Site Not Available

  • Research Site

    Guadalajara, 44340
    Mexico

    Site Not Available

  • Research Site

    Mexico City, 03330
    Mexico

    Site Not Available

  • Research Site

    Monterrey, 64000
    Mexico

    Site Not Available

  • Research Site

    México, 03300
    Mexico

    Site Not Available

  • Research Site

    Grålum, 1714
    Norway

    Site Not Available

  • Research Site

    Lørenskog, N-1478
    Norway

    Site Not Available

  • Research Site

    Oslo, 0456
    Norway

    Site Not Available

  • Research Site

    Tromsø, N-9038
    Norway

    Site Not Available

  • Research Site

    Lisboa, 1250-189
    Portugal

    Site Not Available

  • Research Site

    La Coruña, 15006
    Spain

    Site Not Available

  • Research Site

    Lérida, 25198
    Spain

    Site Not Available

  • Research Site

    Madrid, 28046
    Spain

    Site Not Available

  • Research Site

    Málaga, 29010
    Spain

    Site Not Available

  • Research Site

    Pozuelo de Alarcon, 28223
    Spain

    Site Not Available

  • Research Site

    Santander, 39008
    Spain

    Site Not Available

  • Research Site

    Valencia, 46014
    Spain

    Site Not Available

  • Research Site

    Linköping, 581 85
    Sweden

    Site Not Available

  • Research Site

    Uppsala, 751 85
    Sweden

    Site Not Available

  • Research Site

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Research Site

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Research Site

    Chula Vista, California 91911
    United States

    Site Not Available

  • Research Site

    Montclair, California 91763
    United States

    Site Not Available

  • Research Site

    Orange, California 92868
    United States

    Site Not Available

  • Research Site

    Redondo Beach, California 90277
    United States

    Site Not Available

  • Research Site

    Stanford, California 94305
    United States

    Site Not Available

  • Research Site

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Research Site

    Lakeland, Florida 33813
    United States

    Site Not Available

  • Research Site

    Miami, Florida 33135
    United States

    Site Not Available

  • Research Site

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Research Site

    Yonkers, New York 10701
    United States

    Site Not Available

  • Research Site

    San Antonio, Texas 78229
    United States

    Site Not Available

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