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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 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. The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04781322
The ClinicalTrials.gov registry entry for NCT04781322 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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