Table of Contents
Trial overview
The trial data show one interventional study of Azd4831 in adults with non-cirrhotic NASH with fibrosis, which means a form of fatty liver disease with liver scarring but not cirrhosis.[1]
This study was designed to assess safety, tolerability, and pharmacodynamics, meaning how the treatment affects the body.[1]
Who was studied
The study included adult participants with non-cirrhotic NASH with fibrosis.[1]
The condition description in the trial data explains that NASH is a progressive form of fatty liver disease and is linked with inflammation, liver cell injury, obesity, type 2 diabetes, and abnormal blood fats.[1]
The study data do not list detailed extra entry rules beyond this target group.[1]
What the study measured
The main outcome was the change from baseline and over placebo to Week 12 in ALT, a liver blood test used as a marker of liver injury.[1]
Because the trial also measured safety and tolerability, it was not only about whether the treatment may help, but also about how well people could take it and whether it caused problems.[1]
Placebo was used as a comparison, which helps researchers see whether changes are linked to the study treatment rather than to chance or to the trial setting itself.[1]
Trial phase and status
This was a Phase 2 study, which usually means the treatment is being tested in a specific patient group to learn more about its effects and safety.[1]
The trial status was Completed, and the enrollment was 94 participants.[1]
What the terms mean
Fibrosis means scar tissue in the liver, which can happen after ongoing liver damage.[1]
Non-cirrhotic means the liver has not reached cirrhosis, the most advanced stage of liver scarring.[1]
Pharmacodynamics means the study looked at what Azd4831 does in the body, not just whether it is safe.[1]
ALT is a blood test that can rise when the liver is injured or irritated.[1]
