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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 21 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ ongoing
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ongoing
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The primary objective is to assess the safety and tolerability of alirocumab in subjects who are heavy drinkers.
Secondary outcome measures
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 • NCT0202387915%
Viral upper respiratory tract infection
13%
Fall
10%
Diarrhoea
9%
Back pain
8%
Upper respiratory tract infection
8%
Hypertension
8%
Influenza
8%
Cough
7%
Urinary tract infection
7%
Fatigue
7%
Osteoarthritis
7%
Arthralgia
7%
Injection site reaction
7%
Depression
6%
Musculoskeletal pain
6%
Myalgia
6%
Headache
5%
Non-cardiac chest pain
5%
Oedema peripheral
5%
Dizziness
5%
Gout
4%
Muscle spasms
4%
Bronchitis
3%
Nausea
3%
Rash
3%
Laceration
3%
Acute myocardial infarction
3%
Syncope
3%
Pain in extremity
3%
Sinusitis
2%
Cardiac failure congestive
2%
Basal cell carcinoma
2%
Presyncope
2%
Hypotension
2%
Coronary artery disease
2%
Prostate cancer
1%
Femur fracture
1%
Retinal detachment
1%
Hypovolaemic shock
1%
Small intestinal obstruction
1%
Pharyngitis
1%
Arachnoiditis
1%
Device related infection
1%
Myocardial infarction
1%
Retroperitoneal haematoma
1%
Gastrointestinal haemorrhage
1%
Basedow's disease
1%
Vertigo
1%
Intentional overdose
1%
Bladder transitional cell carcinoma
1%
Post procedural haematoma
1%
Suicide attempt
1%
Haemorrhagic anaemia
1%
Abdominal pain
1%
Cerebrovascular accident
1%
Hyperkalaemia
1%
Aortic valve stenosis
1%
Abdominal wall haematoma
1%
Chest pain
1%
Cholelithiasis
1%
Pneumonia
1%
Subdural haematoma
1%
Vascular pseudoaneurysm
1%
Spinal osteoarthritis
1%
Skin cancer
1%
Multiple sclerosis relapse
1%
Transient ischaemic attack
1%
Haematoma
1%
Peripheral ischaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Alirocumab 150 mg Q4W (After Alirocumab 75 Q2W/Up150 Q2W)
Alirocumab 150 mg Q4W (After Alirocumab 150 Q4W/Up150 Q2W)
Alirocumab 150 mg Q4W/Up150 mg Q2W
Alirocumab 75 mg Q2W/Up150 mg Q2W
Placebo Q2W
Alirocumab 150 mg Q4W (After Placebo 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
800 Previous Clinical Trials
1,362,897 Total Patients Enrolled
81 Trials studying Alcohol Abuse
28,511 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have serious blood disorders.I am taking medication that affects blood clotting.You are seeking treatment for a problem with alcohol.You drink a lot of alcohol regularly and are not seeking treatment for it.I plan to use red yeast rice during the study.My BMI is 40 or higher.I have had bariatric or transplant surgery in the past.I do not have metal implants, a fear of tight spaces, or an MRI-incompatible IUD.I agree to use contraception or abstain from sex.I haven't had plasmapheresis in the last 2 months nor plan to during the study.I have been taking statins for the past 8 weeks or fibrates (except fenofibrates) for the past 6 weeks.My kidney function is reduced, with a GFR less than 60.My bilirubin and creatinine levels are within normal limits, and my kidney function is adequate.You have had a severe allergic reaction to PCSK9 inhibitors, monoclonal antibodies, or any part of the medication.I haven't taken any experimental drugs recently.I do not have any major health issues that could affect my participation in the study.I am not pregnant, not breastfeeding, and will use or am using effective birth control.I have used or am using PCSK9 inhibitors.I have not had serious heart problems in the last year.You have been diagnosed with bipolar disorder, schizophrenia, or other similar mental health conditions.You have had seizures caused by epilepsy or alcohol within the past year.I am between 21 and 65 years old.I have a liver condition not related to alcohol use.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an ongoing recruitment process for this experiment?
"Clinicaltrials.gov attests that this study is presently recruiting participants, having been initially posted on October 19th 2021 and last modified on November 10th 2022."
Answered by AI
What application does Alirocumab typically furnish?
"Alirocumab is commonly administered for myocardial infarction but can also assist in managing hypercholesterolemia, unstable angina pectoris and dietary issues."
Answered by AI
How many people are taking part in this trial at the most?
"Indeed, clinicaltrials.gov reveals that the recruitment process for this medical trial has commenced. It was initially posted on October 19th 2021 and altered most recently on November 10th 2022; it is looking to enroll 100 individuals from a single site."
Answered by AI
Is the eligibility criteria for this research limited to individuals of a certain age?
"As per this research study's eligibility standards, the minimum age for enrollment is 21 and the maximum age permissible is 65."
Answered by AI
Has Alirocumab received clearance from the FDA?
"Due to the preliminary nature of this research, our team at Power gave Alirocumab a score of 1. This is because Phase 1 trials offer only limited information on the drug's safety and effectiveness."
Answered by AI
Has Alirocumab been subjected to previous research studies?
"Presently, there are 10 clinical trials dedicated to evaluating Alirocumab with 1 trial in its final stages. The majority of the studies are located in Chicago, Illinois but 12 other sites across the country have active research initiatives as well."
Answered by AI
Am I permitted to participate in this medical research?
"In order to qualify for this trial, participants must be between 21 and 65 years old, possess a liver ailment, and meet the quota of 100."
Answered by AI
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