Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
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 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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)