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

Summary

Background:

Drinking alcohol can lead to swelling and injury in the liver. Long-term heavy drinking may lead to liver disease. Researchers want to study the relationship between a drug called alirocumab, alcohol use, and liver functioning/swelling.

Objective:

To study the effects of alirocumab in people who drink alcohol.

Eligibility:

Healthy adults ages 21 to 65 who regularly consume an average of 20 or more drinks per week.

Design:

Participants will be screened under protocol 14-AA-0181.

Participants will get alirocumab or a placebo as an injection under the skin.

Participants will give blood and urine samples. They will have physical exams.

Participants will have FibroScans . It measures liver and spleen stiffness. Participants will lie on a table. They will expose the lower right and left side of their chest. The machine will send a small vibration to the liver.

Participants may have magnetic resonance imaging (MRI) scans of the liver. The MRI scanner is shaped like a cylinder. Participants will lie on a table that slides in and out of the scanner. A device called a coil will be placed over their liver.

Participants will have a Doppler scan and ultrasound. These tests measure blood flow in the body.

Participants will have an electrocardiogram. It measures heart function.

Participants will fill out surveys about how they are feeling, their alcohol consumption, and other behaviors. They will complete cognitive tasks on a computer.

Participants will meet with a clinician. They will discuss the participant s assessment results, patterns of drinking, and possibly stopping or cutting down on drinking.

Participation will last for 8 weeks. Participants will have 9 study visits.

Conditions

• Alcohol Associated Liver Disease
• Heavy Drinking Behavior

Interventions

DRUG

Alirocumab

Alirocumab is a human monoclonal antibody (IgG1) that binds to and inhibits PCSK9 and was approved by the FDA in July of 2015. PCSK9 binds to and promotes degradation of low-density lipoprotein receptors (LDLR) on hepatocyte membranes.

OTHER

Placebo

Heavy drinking healthy volunteers

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  lead NIH

Principal Investigators

• Falk W Lohoff, M.D. · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-10-19

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations