Do you or a loved one have a type of fatty liver disease called NASH?
Learn more about NASH and the MK-6024-013 research study for adults with NASH.
What is NASH?
Nonalcoholic steatohepatitis (NASH) is a severe form of fatty liver disease that often has no symptoms but can cause liver damage if not diagnosed early. Eventually it can lead to cirrhosis (advanced late-stage scarring) or liver cancer. NASH is not related to alcohol use.1 If you struggle with your weight or have high blood pressure or high cholesterol, this could be an indication that you may also have NASH.
NATIONAL TRIAL REFERENCE NUMBER
NCT05877547
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
What is the MK-6024-013 Clinical Study?
The MK-6024-013 Clinical Study is testing an investigational study medication in adults who have NASH. The investigational study medication will be compared to a placebo and a medication called semaglutide, which is a medication that is approved in some countries to treat conditions associated with NASH, such as helping manage weight and blood sugar. The study medications will be given as a shot (injection) under the skin once a week using a prefilled syringe or prefilled dose pen.
If you qualify and decide to take part, you will be in this study for about 1 year and 5 months. You will have about 14 visits to the study site for medical tests and assessments. You will also talk with the study doctor or a member of the study team several times by phone.
Researchers want to learn about:
- The safety of the investigational study medication
- How well the investigational study medication works compared to a placebo
- Whether the investigational study medication impacts body weight compared to a placebo
How to Qualify:
You may be able to take part in this study if you:
- Are 18 to 80 years of age
- Have NASH
- Don’t have a chronic liver disease other than NASH or NAFLD (nonalcoholic fatty liver disease)
If you have diabetes, it must be well controlled, with an A1C level of 9% or lower.
If you qualify and decide to participate:
- You will receive the study treatment and all study-related medical care at no cost
- Your NASH and overall health will be closely monitored by a study doctor
- You may be eligible to be reimbursed for study-related travel expenses
Will I receive the investigational study medication?
Study participants will be randomly placed (assigned by chance) into 1 of 5 groups. You will have the same chance of being placed into one of these groups:
- 3 groups will get the investigational study medication (different target dose per group)
- 1 group will get a placebo
- 1 group will get semaglutide, which is a medication approved in some countries to treat conditions associated with NASH, such as helping manage weight and blood sugar
What will happen during this study?
The study has 3 parts: screening, study treatment, and follow-up.
Screening
About 10 weeks
You will have medical tests to see if you qualify for the study. You will visit the study site about 3 times.
Study Treatment
About 52 weeks
During this period you will receive the investigational study medication, a placebo, or semaglutide. You will visit the study site about 10 times.
Follow-up
About 9 weeks
You will have 1 visit about 9 weeks after your last dose of the study medication.
The study doctor or study team may also contact you between study visits to check on your health.
Study Tests
During the study you will have different tests to evaluate your NASH symptoms and overall health. Not all these tests are done at every visit.
Tests include, but are not limited to:
- Physical exam
- Blood and urine test
- ECGs (electrocardiograms, which check your heart function)
- Bone density scan
- VCTE liver scan (FibroScan)
- Liver biopsy
- Pregnancy tests (if you are a person who is able to get pregnant)
- Questions about your health and quality of life
You will also receive a review and counseling about your diet, alcohol intake, and your health.
Trial Locations
Locations shown may have changed in some cases. Use the form below to submit your personal information to the nearest trial site. You can also call the trial sites for more information.
Frequently Asked Questions
About NASH
You may be more likely to develop NASH if you have any of the following conditions:3
- Obesity
- High cholesterol
- High blood pressure
- Elevated liver enzymes
- Type 2 diabetes
- Family history
To diagnose NASH, doctors start with a medical history, physical exam, and blood tests. Your doctor may then order imaging tests—such as an MRI (magnetic resonance imaging), ultrasound, or CT scan—and confirm the diagnosis with a liver biopsy.
Even though you may not have heard of NASH, the number of cases is rising quickly. Less than 7% of adults worldwide have NASH.4 In the Hispanic population, almost 20% of people worldwide have NASH.4
About the MK-6024-013 Clinical Study
The MK-6024-01 Clinical Study is testing the safety of an investigational study medication. The clinical trial is also testing how well the investigational study medication works compared to a placebo and how well it impacts body weight compared to a placebo.
Before you agree to participate, the study team will review all aspects of the clinical study with you. If you are eligible and decide to take part, you will be given a document called an Informed Consent Form that provides, in writing, the clinical study’s purpose, assessments, procedures, potential benefits and risks, and precautions. You will have the opportunity to ask questions and decide if participating is right for you.
A placebo looks like the study medicine but does not contain any active medication. In this research study, you will be randomly placed (assigned by chance) into 1 of 5 study treatment groups. There is a:
- 3 in 5 (60%) chance of receiving the investigational study medication
- 1 in 5 (20%) chance of receiving semaglutide
- 1 in 5 (20%) chance of receiving a placebo
Privacy, Stopping Participation, Costs, and Permission
The study team respects and protects your privacy. They will not share your information except as required by law and will store your personal information with codes that do not identify you. The Informed Consent Form (completed by you prior to participation) will provide more information about how your privacy will be maintained.
Yes, your participation in the clinical study is entirely voluntary and you may withdraw for any reason, at any time. If you do decide to withdraw early, you will be asked to notify the study team before doing so. You will be asked to return to the study site at least once to complete a final visit and return any unused drug.
No, you will get the study treatment at no cost. You will also get all study-related medical tests at no cost.
No, your doctor does not have to give permission for you to participate. However, either you or the study doctor, with your permission, may contact your personal doctor to discuss your participation before you begin and keep your doctor up to date about your progress.
About Clinical Research
A clinical study, sometimes called a research study or clinical trial, tries to answer questions about how medications work in the people who take them. Researchers run studies to test whether a study medication is safe and effective. These studies may help doctors find new ways to help prevent, detect, or treat health problems.
Participant safety is the priority. There are rules in place to help protect the rights, safety, and well-being of people who volunteer for research studies. These rules are put in place to make sure studies follow strict scientific and ethical guidelines.
Before a clinical study can begin, a review board or ethics committee must review the study. In the US, this group is called an IRB or Institutional Review Board. In other countries, this group is called an EC or Ethics Committee. IRBs and ECs are made up of doctors, scientists, and other members of the community.
Only people who meet all eligibility criteria for a clinical study may take part. The study team will review your medical history and current medical status against the eligibility criteria. They will determine if you are eligible to participate. You may also be asked to provide information from your medical records to help the study team determine whether you may be eligible.
An investigational study medication is a medication that hasn’t yet been approved for use in the general public. In order to be approved, the investigational study medication must be tested in clinical studies to see if it is safe and effective for treating the target disease in certain groups of people.
The investigational study medication in the MK-6024-013 Clinical Study is testing an investigational study medication in adults who have NASH. The study also evaluates how the investigational study medication affects body weight.
If you are eligible and choose to participate, the study staff will be available to answer any questions you may have.
For more answers to your questions, visit: https://www.merckclinicaltrials.com/faq/
What can you do next?
If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Discuss with your doctor or care team
Print this page with details about the trial or email it to your doctor to discuss the clinical trial during your next visit.
Get help talking with your doctor or care team
Contact our Trial Information Center
To learn more, call 1-888-577-8839.
NATIONAL TRIAL REFERENCE NUMBER
NCT05877547
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational treatment that is being studied
- What the risks and possible benefits are for participants
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about
References:
- Brochure for patients who have been diagnosed with NAFLD or NASH. Global Liver Institute. Accessed September 19, 2023, https://static1.squarespace.com/static/53bafdce4b0a6714af715ft5cc8b8158165f5f89b2c49d61556658197576nash-factsheets-treatment-4print.pdf
- Treatment for NAFLD and NASH. National Institute of Diabetes and Digestive and Kidney Diseases. Accessed September 19, 2023 https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash/treatment
- NASH Causes and Risk Factors. American Liver Foundation. Accessed September 19, 2023 https://liverfoundation.org/liver-diseases/fatty-liver-disease/nonalcoholic-steatohepatitis-nash/nash-causes-risk-factors/
- How prevalent is NASH? The NASH Education Program. Accessed September 19, 2023 https://www.the-nash-education-program.com/what-is-nash/how-prevalent-is-nash/#;~.text=Prevalence%20worldwide%A&text=NASH%A%201.5%E2%80%966.45%25