Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers

Description

Study Description:

The PCSK9 inhibitor alirocumab has been recently shown to attenuate alcohol-induced hepatic triglyceride accumulation, hepatocellular injury and hepatic inflammation in a rat model of chronic alcohol exposure. Given the unmet clinical need for novel treatment options for alcohol-associated liver disease (ALD), we are proposing to conduct a safety and tolerability study of alirocumab in this new target population.

We hypothesize that alirocumab will be well tolerated and safe in this new target population and alirocumab will attenuate alcohol-induced liver damage and inflammatory biomarkers.

Objectives:

Primary Objective: The primary objective is to assess the safety and tolerability of alirocumab in subjects who are heavy drinkers.

Secondary/Exploratory Objectives: Secondary/exploratory objectives are to assess various biomarkers related to alcohol-induced liver damage and inflammation.

Endpoints:

Primary Endpoint: The primary endpoint in the study is to assess the incidence and severity of treatment-emergent adverse events in non-treatment seeking heavy drinkers treated with alirocumab or placebo. [Time Frame: baseline to week 8]

Secondary/exploratory Endpoints: The secondary endpoint is to explore effects of alirocumab on various biomarkers using change from baseline.