Phase 2-3
Phase 2-3 Trials
Participating in a clinical trial is an opportunity to access cutting-edge treatments and contribute to advancing
medical research. Your involvement helps researchers discover new therapies, improve existing ones, and better
understand diseases. By joining, you can make a meaningful impact on your health and the health of others.
About Each Phase
Phase 1 - Is it Safe?
Earliest phase to assess safety and side effects. Without Phase 1 trials, medicines/treatments would take longer and be less safe for patients that need it most. “Life’s most persistent and urgent question is: What are you doing for others?” ~ Martin Luther King, Jr.
Phase 2 - Does it Work?
Determine safety, efficacy (how well the medicine works), and best amount of the drug to give to patients with specific conditions. This is usually a smaller and more specific patient population.
Phase 3 - Does it Work?
Continue to determine safety, efficacy (how well the medicine works), and best dosing in patients with specific conditions with a larger number of patients and more diverse patient populations. This data is then provided to the FDA to ask for permission to make available for commercial use for doctors.*The medicines we study in Phases 2 and 3 have already passed many tests.
Phase 2 & 3: The Basics
Assessing if a new liver disease medication will aid the body in correcting liver damage that might lead to disease progression or more serious outcomes like steatohepatitis or cirrhosis.
Phase 2/3 trials are primarily done through patient/participant volunteers – made up of participants with mild to more severe liver disease that have been screened, diagnosed, and meet the trial protocol criteria requirements.
Phase 2 fatty liver disease trials can last several months up to 2 years.
Phase 3 fatty liver disease trials can vary but usually last for 2-3 years.
Each study has a plan that tells us how often you’ll get treatments. They might be a few weeks or even months apart. Our research team will make sure you know the schedule once you join.
In trials, some people receive the trial medicine, and some receive a placebo, which is like a pretend pill. This helps us learn if the real medicine is working. The chance of placebo varies in each study.
Each study has a plan that tells us how often you’ll get treatments. They might be a few weeks or even months apart. Our research team will make sure you know the schedule once you join.
Main focus
Assessing if a new liver disease medication will aid the body in correcting liver damage that might lead to disease progression or more serious outcomes like steatohepatitis or cirrhosis.
Volunteers
Phase 2/3 trials are primarily done through patient/participant volunteers – made up of participants with mild to more severe liver disease that have been screened, diagnosed, and meet the trial protocol criteria requirements.
Duration
Phase 2 fatty liver disease trials can last several months up to 2 years. Phase 3 fatty liver disease trials can vary but usually last for 2-3 years.
What to Expect with Treatments
Each study has a plan that tells us how often you’ll get treatments. They might be a few weeks or even months apart. Our research team will make sure you know the schedule once you join.
The Placebo Factor
In trials, some people receive the trial medicine, and some receive a placebo, which is like a pretend pill. This helps us learn if the real medicine is working. The chance of placebo varies in each study.
Placebo Shouldn't Stop You
Each study has a plan that tells us how often you’ll get treatments. They might be a few weeks or even months apart. Our research team will make sure you know the schedule once you join.
Before You Participate
Informed Consent
This is a document that your clinical team will review with you describing the study, including the medicines, procedures, possible risks, schedule, and length of the study. Your rights as a participant are also outlined.
Full Trial Understanding
Our team will go over every detail with you. Once you're comfortable and understand the potential risks and benefits you will be asked to sign the consent form if you wish.
Voluntary Participation
You have the right to stop taking part of the study at any time, for any reason. You'll be compensated for the portion of the study you complete.
Potential Compensation & Reimbursement
We may compensate participants throughout their treatment. The payment amount and frequency will vary with every unique trial. Travel costs may be included in your overall study compensation or reimbursed separately.
We thank you for considering being a part of this journey. Your dedication can pave the way for safer medicines and treatments. Together, we can make a difference.
