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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 262 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since Apr 25, 2026, no change to tracked fieldsv261-v262
  2. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026v260
  3. 4 versions Re-verified since Jan 18, 2025, no change to tracked fieldsv256-v259
  4. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025v255
  5. 4 versions Re-verified since Aug 13, 2024, no change to tracked fieldsv251-v254
Show 38 earlier versionsHide 38 earlier versions
  1. Eligibility criteria revisedv250
  2. Re-verified, no change to tracked fieldsv249
  3. Eligibility criteria expanded, about 5 wordsv248
  4. Re-verified, no change to tracked fieldsv247
  5. Primary and study completion dates: Dec 31, 2023 to Dec 31, 2024v246
  6. Eligibility criteria shortened, about 43 wordsv245
  7. 6 versions Re-verified since Nov 10, 2022, no change to tracked fieldsv239-v244
  8. Eligibility criteria expanded, about 19 wordsv238
  9. Re-verified, no change to tracked fieldsv237
  10. Eligibility criteria expanded, about 10 wordsv236
  11. Enrollment target: 30 to 100v235
  12. 16 versions Re-verified since Jun 9, 2022, no change to tracked fieldsv219-v234
  13. Eligibility criteria revised
    • Study description shortened, about 84 words
    v218
  14. 5 versions Re-verified since Jun 1, 2022, no change to tracked fieldsv213-v217
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04781322
Lead Sponsor National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions
(from sponsor)		 Alcohol Associated Liver Disease, Heavy Drinking Behavior
Related terms Fatty Liver, Inflammation
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov