Actively Recruiting
Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers
Led by National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Updated on 2026-04-28
100
Participants Needed
1
Research Sites
271 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between the age of 21 and 65 years
- Ability to provide written informed consent
- Females must have a negative urine pregnancy test, not be breastfeeding, and agree to use accepted contraception or abstain from sex
- Males must agree to use accepted contraception or abstain from sex
- Current chronic alcohol use with an average of 20 or more standard drinks per week for at least 12 weeks
You will not qualify if you...
- Seeking treatment for alcohol use disorder
- History of serious allergic reaction to PCSK9 inhibitors, monoclonal antibodies, or any drug components
- Recent use of statins or fibrates (except fenofibrates) within specified weeks before study
- Current or past use of PCSK9 inhibitors
- Significant or unstable cardiovascular disease in the past 12 months
- History or current presence of significant diseases such as fibromyalgia, seizure disorder, endocrine diseases affecting lipids, recent cancer, uncontrolled diabetes, or other serious abnormalities
- Positive tests for HIV, Hepatitis B, or Hepatitis C
- Elevated liver enzymes or bilirubin beyond set limits
- High triglycerides above 400 mg/dL
- Chronic kidney failure with low filtration rate
- Other significant acute or chronic liver diseases unrelated to alcohol
- Blood clotting disorders or use of blood clotting medications
- Significant blood abnormalities
- Severe obesity with BMI 40 or above
- History of bariatric or transplant surgery
- Recent or planned plasmapheresis treatment
- Use of certain medications including intramuscular injections, systemic corticosteroids (unless stable), or hormone therapies unless stable
- Recent use of investigational drugs
- Planned use of red yeast rice during the study
- Current suicidality
- History of epilepsy or alcohol-related seizures in the last year
- Severe mental or neurological conditions that impair participation
- For MRI: presence of metal in body, fear of enclosed spaces, or MRI-incompatible IUD use
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
Nada M Saleh
CONTACT
F
Falk W Lohoff, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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