At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 112 enrolled
Drug / intervention
AZD4831 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating AZD4831 and Placebo for Non-Cirrhotic Non-alcoholic Steatohepatitis With Fibrosis. Completed, enrolled 112 participants across 65 sites in 9 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Denmark, Italy, Mexico, Norway, Portugal, Spain, Sweden, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2023202420252026
Enrollment StartOct 2022
First PostedDec 2022
Primary CompletionApr 2024
TodayJul 2026
First PostedDec 6, 2022
Enrollment StartOct 26, 2022
Primary CompletionApr 4, 2024
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 3.6 years ago
Interventions
AZD4831drug
AZD4831
Placeboother
Placebo