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Study identifier: NCT04781322 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Alcohol Associated Liver Disease · Heavy Drinking Behavior  ·  Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

PhasePhase 1
Planned participants100
Who can joinAll sexes, 21 Years to 65 Years
Healthy volunteersYes

About this study

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 …

This description comes directly from the study's public registry record.

Talk to the study team

Nada M Saleh  ·  (301) 496-3799  ·  nada.saleh@nih.gov

Falk W Lohoff, M.D.  ·  (301) 827-1542  ·  falk.lohoff@nih.gov

Always discuss trial participation with your own doctor first.

Locations (1)

National Institutes of Health Clinical CenterBethesda, Maryland, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04781322