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NCT04781322 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers
A Phase 1 study of Alcohol-associated Liver Disease and Heavy Drinking Behavior, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT04781322: Recruiting Phase 1 study of Alcohol-associated Liver Disease and Heavy Drinking Behavior, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT04781322 is a Phase 1 study of Alcohol-associated Liver Disease and Heavy Drinking Behavior that is actively recruiting participants, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04781322, a Phase 1 study of Alcohol-associated Liver Disease and Heavy Drinking Behavior, is actively recruiting participants, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The primary endpoint in the study is to assess the incidence and severity of treatment-emergent adverse events in non-treatment seeking heavy drinkers treated with alirocumab or placebo.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Alirocumab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-10-19 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What NCT04781322 shows while recruiting
NCT04781322 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).
The record links to 2 conditions, with Alcohol-associated Liver Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04781322 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04781322 about?
NCT04781322 is a clinical study titled "Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers". 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...
What is the current status of trial NCT04781322?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2021-10-19. Estimated completion is 2026-12-31.
What conditions does trial NCT04781322 study?
This clinical trial studies the following conditions: Alcohol-associated Liver Disease, Heavy Drinking Behavior.
What interventions are being tested in trial NCT04781322?
The interventions under investigation include: Placebo (OTHER), Alirocumab (DRUG).
Who is sponsoring clinical trial NCT04781322?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04781322 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04781322's enrollment target sits among peer trials
100 547th of 2000 higher than 1,411 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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