NCT04781322

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

Recruiting now Phase 1 Last updated 14 January 2026

What this trial tests

Phase 1 trial testing Alirocumab in Alcohol Associated Liver Disease in 100 participants. Currently enrolling.

Timeline

19 October 2021

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	100
Start date	19 October 2021
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across United States

Drugs / interventions tested

• Alirocumab (ALIROCUMAB) — full drug profile →
• Placebo

Conditions studied

• Alcohol Associated Liver Disease — all drugs for Alcohol Associated Liver Disease →
• Heavy Drinking Behavior — all drugs for Heavy Drinking Behavior →

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Who can join

Adults 21 to 65, any sex, with Alcohol Associated Liver Disease or Heavy Drinking Behavior. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. From geroscience to precision geromedicine: Understanding and managing aging.
   Kroemer G, Maier AB, Cuervo AM, Gladyshev VN, et al · · 2025 · cited 139× · PMID 40250404 · DOI 10.1016/j.cell.2025.03.011
2. Targeting proprotein convertase subtilisin/kexin type 9 (PCSK9): from bench to bedside.
   Bao X, Liang Y, Chang H, Cai T, et al · · 2024 · cited 101× · PMID 38185721 · DOI 10.1038/s41392-023-01690-3
3. MetALD: Does it require a different therapeutic option?
   Marek GW, Malhi H. · · 2024 · cited 21× · PMID 38820071 · DOI 10.1097/hep.0000000000000935