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

NCT04781322

This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Alcohol Associated Liver Disease
  • Heavy Drinking Behavior

Eligibility basics and study details

Study type
Interventional
Phase
Phase 1
Ages
21 to 65 years
Sex
All
Healthy volunteers
Accepted
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Last updated on ClinicalTrials.gov
July 20, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Maryland · 1

  • National Institutes of Health Clinical Center · Bethesda, MD

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.