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A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, and Pharmacodynamics of AZD4831 in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) with Fibrosis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500594-13-00
Acronym
D6581C00001
Enrollment
48
Registered
2022-10-27
Start date
2022-12-14
Completion date
2024-04-04
Last updated
2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Sponsors

Astrazeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline and over placebo to Week 12: ALT

Secondary

MeasureTime 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

Source: EU CTIS · Data processed: Feb 4, 2026