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Monoclonal Antibodies

Alirocumab for Alcohol Use Disorder

Phase 1
Recruiting
Led By Falk W Lohoff, M.D.
Research Sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female between the age of 21 and 65 years
Be older than 18 years old
Must not have
Patients with significant hematologic abnormalities
Use of any medications that interfere with blood clotting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks

Summary

This trial is testing the effects of alirocumab in people who drink alcohol. People who drink 20 or more drinks per week may be eligible. The trial will last 8 weeks.

Who is the study for?
Adults aged 21-65 who are heavy drinkers (consuming over 20 drinks weekly) but not seeking treatment for alcohol use can join. They must be generally healthy, with liver tests showing some elevation. Women must test negative for pregnancy and agree to contraception; men also need to commit to using contraception.
What is being tested?
The trial is testing alirocumab's safety and effects on the liver in heavy drinkers. Participants will receive either alirocumab or a placebo via injection and undergo various scans, blood tests, heart function tests, surveys about their well-being and drinking habits, as well as discussions about their alcohol consumption.
What are the potential side effects?
Potential side effects of alirocumab may include reactions at the injection site like redness or pain, symptoms of colds such as runny nose or sore throat, nausea, flu-like symptoms, muscle pain and allergic reactions which could manifest through rash or swelling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have serious blood disorders.
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I am taking medication that affects blood clotting.
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I plan to use red yeast rice during the study.
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My BMI is 40 or higher.
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I have had bariatric or transplant surgery in the past.
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I haven't had plasmapheresis in the last 2 months nor plan to during the study.
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My kidney function is reduced, with a GFR less than 60.
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My bilirubin and creatinine levels are within normal limits, and my kidney function is adequate.
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I haven't taken any experimental drugs recently.
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I do not have any major health issues that could affect my participation in the study.
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I have used or am using PCSK9 inhibitors.
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I have not had serious heart problems in the last year.
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I have a liver condition not related to alcohol use.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ongoing
This trial's timeline: 3 weeks for screening, Varies for treatment, and ongoing for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The primary objective is to assess the safety and tolerability of alirocumab in subjects who are heavy drinkers.
Secondary study objectives
Secondary/exploratory objectives are to assess various biomarkers related to alcohol-induced liver damage and inflammation.

Side effects data

From 2017 Phase 3 trial • 233 Patients • NCT02023879
19%
Viral upper respiratory tract infection
15%
Back pain
15%
Injection site reaction
10%
Oedema peripheral
10%
Bronchitis
10%
Urinary tract infection
8%
Upper respiratory tract infection
8%
Influenza
8%
Headache
8%
Dizziness
6%
Osteoarthritis
6%
Arthralgia
6%
Hyperkalaemia
6%
Nausea
6%
Fatigue
4%
Pneumonia
4%
Hypertension
4%
Diarrhoea
4%
Syncope
4%
Musculoskeletal pain
4%
Fall
2%
Rhabdomyolysis
2%
Rash
2%
Cough
2%
Breast cancer
2%
Peripheral artery stenosis
2%
Faecaloma
2%
Myalgia
2%
Chronic obstructive pulmonary disease
2%
Pain in extremity
2%
Sinusitis
2%
Cellulitis
2%
Lumbar spinal stenosis
2%
Gout
2%
Atrial fibrillation
2%
Non-cardiac chest pain
2%
Cerebellar infarction
2%
Basal cell carcinoma
2%
Mental disorder
2%
Jaw fracture
2%
Arthritis
2%
Musculoskeletal chest pain
2%
Muscle spasms
2%
Small intestinal obstruction
2%
Hypoxic-ischaemic encephalopathy
2%
Coronary artery disease
2%
Cardio-respiratory arrest
100%
80%
60%
40%
20%
0%
Study treatment Arm
Alirocumab 150 mg Q4W (After Alirocumab 150 Q4W/Up150 Q2W)
Placebo Q2W
Alirocumab 75 mg Q2W/Up150 mg Q2W
Alirocumab 150 mg Q4W/Up150 mg Q2W
Alirocumab 150 mg Q4W (After Placebo Q2W)
Alirocumab 150 mg Q4W (After Alirocumab 75 Q2W/Up150 Q2W)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Heavy drinking healthy volunteers
Group II: PlaceboPlacebo Group1 Intervention
Heavy drinking healthy volunteers
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alirocumab
2012
Completed Phase 3
~23510

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)Lead Sponsor
835 Previous Clinical Trials
1,082,670 Total Patients Enrolled
81 Trials studying Alcohol Abuse
27,491 Patients Enrolled for Alcohol Abuse
Falk W Lohoff, M.D.Principal InvestigatorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
1 Previous Clinical Trials
96 Total Patients Enrolled

Media Library

Alirocumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04781322 — Phase 1
Alcohol Abuse Research Study Groups: Intervention, Placebo
Alcohol Abuse Clinical Trial 2023: Alirocumab Highlights & Side Effects. Trial Name: NCT04781322 — Phase 1
Alirocumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04781322 — Phase 1
~3 spots leftby Dec 2024
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