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A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, and Pharmacodynamics of AZD4831 (Mitiperstat) in Participants With Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) With Fibrosis
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.
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Research Site
Chandler, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Chula Vista, California, United States
Research Site
Montclair, California, United States
Research Site
Orange, California, United States
Research Site
Redondo Beach, California, United States
Research Site
Stanford, California, United States
Research Site
Jacksonville, Florida, United States
Research Site
Lakeland, Florida, United States
Research Site
Lakeland, Florida, United States
Start Date
October 26, 2022
Primary Completion Date
April 4, 2024
Completion Date
April 4, 2024
Last Updated
July 9, 2025
112
ACTUAL participants
AZD4831
DRUG
Placebo
OTHER
Lead Sponsor
AstraZeneca
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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