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Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional
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
At a glance
Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Astrazeneca AB
Enrolment target
48
Start
27 Oct 2022
"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 complicationshepatocellular carcinomaand end stage liver disease.
Non-alcoholic steatohepatitis is defined histologically as a multicomponent condition
composed of hepatic steatosisinflammationand 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 obesityT2DMand dyslipidemia. PathophysiologicallyNASH is frequently associated with a hyperinsulinemic or insulin resistant stateleading to adipose tissue dysfunction and increased hepatic de novo lipogenesis."
What is this study about?
Change from baseline and over placebo to Week 12: ALT
Who may be eligible?
Age 18 Years to any · Sex: All
Locations (6)
- —Sweden
- —Spain
- —Denmark
- —Italy
- —Norway
- —Portugal
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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