General Study Questions
How long will I be in the study?
You will be in the study for up to 11 months (less than 1 year).
How many times will I have to go to the study site?
During the study, you will have up to 16 study visits. During the study visits, you will have tests and procedures.
Do I have to attend all study visits?
It’s important to attend all scheduled visits to check on your health and to see how the study treatment may be affecting you.
What are the benefits of being in the clinical study?
You may or may not directly benefit from being in the clinical study. However, your health will be monitored regularly throughout the study by doctors with expertise in liver disease. Any information collected during the study may help doctors learn more about treating others with similar alcohol-related health problems in the future.
Will it cost me anything to be in the study?
You do not have to pay to take part in this study. You will get the study drug and all the study tests and procedures at no cost.
Who is sponsoring the study?
The global biopharma company GlaxoSmithKline is sponsoring the study. They pay the staff at the study site to run this study.
What if I decide to join the study and then change my mind?
Being in the study is voluntary. If you decide to join and then change your mind, you can leave the study at any time. Leaving the study will not affect your regular medical care.
Study Treatment Questions
What study treatment will I receive?
If you qualify for the study, you will be assigned by chance to receive either the study drug or the placebo. The placebo looks just like the study drug but does not contain active medicine.
How are the study treatment groups assigned?
A computer system will be used to assign participants to study treatment groups by chance. This is called randomization.
Will I know what study treatment I’m receiving?
You and the study team will not know which study treatment you are receiving. This helps to keep the study fair and unbiased.
How does the study drug work?
The study drug works by lowering the amount of a protein made in the liver that is thought to be involved in the development and worsening of ALD. By lowering the amount of this protein, the study drug may be able to reduce the toxic effects of alcohol on the liver.
Are there any side effects from the study drug?
As with all medicines, there is a chance for side effects, which are unwanted or unintended effects of a medicine. Talk to the study doctor for more information on possible side effects. Your health will be closely monitored during the entire study. Inform the study doctor if you notice any side effects or changes in your health.
Will I still receive the study treatment if I drink alcohol during the study?
Stopping alcohol drinking is recommended for people living with liver disease. However, this may not always be possible. You will still be able to participate in this study even if you have not stopped drinking.