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RECRUITING
NCT04781322
PHASE1

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

Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

View on ClinicalTrials.gov

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.

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Study of Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers

Key Details

Gender

All

Age Range

21 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2021-10-19

Completion Date

2026-12-31

Last Updated

2026-01-14

Healthy Volunteers

Yes

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

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States