and dyslipidemia. Pathophysiologically, and end stage liver disease. Non-alcoholic steatohepatitis is defined histologically as a multicomponent condition composed of hepatic steatosis, and hepatocyte ballooning in varying proportions. NASH differs from steatosis alone by the presence of hepatic cell inflammation and injury in response to lipotoxic intermediates that are accumulated and metabolized in the steatotic liver. NASH is closely associated with metabolic risk factors including obesity, hepatocellular carcinoma, inflammation, leading to adipose tissue dysfunction and increased hepatic de novo lipogenesis.", NASH is frequently associated with a hyperinsulinemic or insulin resistant state, "Non-Alcoholic Steatohepatatis (NASH) is the progressive form of Non-Alcoholic Fatty Liver Disease (NAFLD)with a prevalence of approximately 2% to 3% of the general population. Non-alcoholic steatohepatitis can lead to cirrhosis and its complications, T2DM
Conditions
Brief summary
Change from baseline and over placebo to Week 12: ALT
Detailed description
Change from baseline and over placebo to Week 12: ProC3, Plasma concentration of AZD4831 will be summarized by timepoints and dose level. If PK data permit, a population PK model may be developed and potentially coupled with separate PD models; the derived PK parameters and the modelling will be provided in a separate PK and population PK/PD report.
Interventions
DRUGAZD4831 Placebo
DRUGAZD4831
Sponsors
Astrazeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline and over placebo to Week 12: ALT | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline and over placebo to Week 12: ProC3, Plasma concentration of AZD4831 will be summarized by timepoints and dose level. If PK data permit, a population PK model may be developed and potentially coupled with separate PD models; the derived PK parameters and the modelling will be provided in a separate PK and population PK/PD report. | — |
Countries
Denmark, Italy, Norway, Portugal, Spain, Sweden
Outcome results
None listed