Do you or a loved one have cirrhosis of the liver caused by metabolic dysfunction-associated steatohepatitis (MASH)?
Learn more about MASH and the MK-6024-017 research study for adults with MASH.
What is cirrhosis caused by MASH?
Metabolic dysfunction-associated steatohepatitis (MASH, previously called NASH) is a severe form of fatty liver disease associated with health issues such as being overweight, having type 2 diabetes, a high LDL (bad cholesterol), and metabolic syndrome.
Cirrhosis is a serious form of MASH, where the buildup of fat and inflammation leads to stiffness and scarring of the liver. Cirrhosis can lead to liver failure and cancer.
View full trial information on ClinicalTrials.gov
NATIONAL TRIAL REFERENCE NUMBER
NCT06465186
When you talk with your doctor or clinical trial team member, please have the trial identifier number or the EudraCT number available.
What is the MK-6024-017 Clinical Study?
This clinical study is evaluating an investigational study medication, MK-6024, in adults with cirrhosis of the liver due to MASH. Researchers will compare the investigational study medication to a placebo. A placebo looks like the investigational study medication but has no active ingredients.
The investigational study medication is given by injection (a shot) just under the skin. The injection is put in the fatty area of the abdomen, thigh, or upper arm 1 time per week using a prefilled syringe.
If you qualify and decide to take part, you will be in this study for about 43 weeks (about 10 months). You will have around 10 scheduled visits to the study site for medical tests and assessments. You will also have at least 3 phone call visits with the study doctor or a member of the study team.
Researchers want to learn about:
- The safety of MK-6024 and how well people tolerate taking it
- How well MK-6024 may work compared to a placebo
- Whether MK-6024 may affect body weight compared to a placebo
About 80 people will participate in this study.
How to Qualify:
You may be able to take part in this study if you:
- Are 18 to 80 years of age
- Have a diagnosis of cirrhosis of the liver caused by MASH
- Do not have diabetes, OR if you do have type 2 diabetes, your A1C is at or below 9%
- Do not have another chronic liver disease
Additional requirements apply, which the study doctor can discuss with you.
If you qualify and decide to participate:
You may be eligible to be reimbursed for study-related travel expenses
You will receive the study treatment and all study-related medical care at no cost
Your MASH, cirrhosis, and overall health will be closely monitored by a study doctor
Will I receive the investigational study medication?
People who take part in this study will be randomly placed (assigned by chance) into 1 of 2 groups:
- Group 1 will get the investigational study medication
- Group 2 will get a placebo
Each participant has an equal chance of being put into each group. During the study, participants will also continue to take their usual medications.
What will happen during this study?
The study has 3 parts: screening, study treatment, and follow-up.
Screening
About 7 weeks
You will have medical tests to see if you qualify for the study. You will visit the study site 2 or more times.
Treatment
About 28 weeks
You will receive the investigational study medication or a placebo. You will visit the study site about 7 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 health. Not all tests are done at every visit.
Tests include, but are not limited to:
- Physical exams
- Blood tests
- Vital signs (heart rate and blood pressure)
- ECGs (electrocardiograms, which check your heart)
- VCTE liver scan (FibroScan)
- MRIs (Magnetic Resonance Imaging)
- Pregnancy tests (if you are able to get pregnant)
- Answering questions about your health and quality of life
You will also receive a review of and counseling about your diet, exercise, and use of alcohol. If you have type 2 diabetes, additional review and management of high or low blood sugar will be provided.
Trial Locations
Locations shown may have changed in some cases. When you enter your zip code, the map will show the closest site to your area. Click the “Submit Your Info” button to provide additional information to see if you may qualify. You can also call the trial sites for more information.
Frequently Asked Questions
About MASH & Cirrhosis
You may be more likely to develop MASH if you have any of the following conditions 1:
- Obesity
- High cholesterol
- High blood pressure
- Elevated liver enzymes
- Type 2 diabetes
- Family history
People with MASH don’t usually have symptoms. A diagnosis of MASH is typically considered when people have abnormal liver tests without another explanation or when abdominal imaging shows a buildup of fat in the liver. Your doctor may then order additional imaging, blood tests, and a liver biopsy to confirm the diagnosis.2
Cirrhosis is the scarring of liver tissue caused by fat buildup, swelling, and inflammation. It can lead to end-stage liver disease, cancer, and death.3
MASH is one of the leading causes of cirrhosis.3 About 20% of people with MASH will develop cirrhosis.4
About the MK-6024-17 Clinical Study
The MK-6024-17 Clinical Study is evaluating the safety of an investigational study medication. The clinical study is also examining how well the investigational study medication works compared to a placebo and how it may affect liver fat, scarring, stiffness, and 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 investigational study medication but does not contain any active medication. In this research study, you will be randomly placed (assigned by chance) into 1 of 2 study treatment groups. There is a 50% chance of receiving either the investigational study medication or 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 evaluate 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 clinical 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 at the site you select 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 medicine 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 MK-6024-17 Clinical Study is evaluating an investigational study medication in adults who have cirrhosis due to MASH to see how it may affect liver fat, scarring, stiffness, and 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/
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.
References:
- Yanai H, Adachi H, Hakoshima M, Hiroki A, Lida S, Katsuyama H. Metabolic-dysfunction-associated steatotic liver disease—its pathophysiology, association with atherosclerosis and cardiovascular disease, and treatments. Int J Mol Sci. 2023 Oct 23;24(20):15473. doi:10.3390/ijms242015473
- Friedman SL, Neuschwander-Tetri BA, Rinella M, Sanyal AJ. Mechanisms of NAFLD development and therapeutic strategies. Nat Med. 2018 Jul; 24:908-22. doi:10.1038/s41591-018-014-9
- Cirrhosis of the Liver. American Liver Foundation. Accessed June 7, 2024. https://liverfoundation.org/liver-diseases/complications-of-liver-disease/cirrhosis/
- Sheka AC, Adeyi O, Thompson J, Hameed B, Crawford PA, Ikramuddin S. Nonalcoholic steatohepatitis: a review. JAMA. 2020 Mar 24-31;323(12):1175-83. Erratum in: JAMA. 2020 Apr 28;323(16):1619. doi:10.1001/jama.2020.2298