A Study in Participants With Non-cirrhotic NASH With Fibrosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-Cirrhotic Non-alcoholic Steatohepatitis With Fibrosis

In brief

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.

Key facts

Study ID: NCT05638737
Run by: AstraZeneca
People needed: 112
Starts: 2022-10-26
Expected to finish: 2024-04-04
Last updated by the study team: 2025-07-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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).
History of excessive alcohol consumption, defined as an average weekly intake of > 21 drinks/week for males or > 14 drinks/week for females. One drink is equivalent to 14 g alcohol.
Recent (within 3 months of randomization) use of drugs approved for weight loss (eg, orlistat, bupropion/naltrexone, phentermine-topiramate, phentermine, lorcaserin), as well as those drugs used off-label.
High dose vitamin E (> 400 IU) unless on a stable dose within 6 months of screening.
Recent (within 6 months of screening) use of therapies associated with development of NAFLD (eg, systemic corticosteroids, methotrexate, tamoxifen, amiodarone, or long-term use of tetracyclines).
Recent (within 6 months of screening) use of obeticholic acid or other therapy under investigation for NASH.

Where it is running

Research Site — Guadalajara, Mexico
Research Site — Guadalajara, Mexico
Research Site — Mexico City, Mexico
Research Site — Mexico City, Mexico
Research Site — Mexico City, Mexico
Research Site — México, Mexico
Research Site — Monterrey, Mexico
Research Site — Monterrey, Mexico
Research Site — Monterrey, Mexico
Research Site — Gjøvik, Norway
Research Site — Grålum, Norway
Research Site — Lørenskog, Norway
Research Site — Oslo, Norway
Research Site — Tromsø, Norway
Research Site — Lisbon, Portugal
Research Site — A Coruña, Spain
Research Site — Lleida, Spain
Research Site — Madrid, Spain
Research Site — Málaga, Spain
Research Site — Pozuelo de Alarcón, Spain
Research Site — Santander, Spain
Research Site — Valencia, Spain
Research Site — Linköping, Sweden
Research Site — Uppsala, Sweden
Research Site — Guadalajara, Mexico

Full record on ClinicalTrials.gov

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