MONARCH is a clinical research study to learn whether the study drug, miricorilant can safely and effectively reduce the amount of liver fat in people with MASH (formerly known as NASH).
You may be able to join if you meet the following criteria:
18 through 75 years old.
Diagnosed with MASH.
Have type 2 diabetes or at least 3 of these conditions: Prediabetes, overweight or obese, high blood pressure, high blood triglycerides, and low HDL cholesterol.
If you do not know whether you have MASH, the study can help you find out.
Other study requirements will apply.
Participation in the MONARCH study lasts about 40 (Cohort B) to 60 (Cohort A) weeks. Study participants can expect the following:
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
Take the pre-screener to see if you may qualify!
Take the Pre-ScreenerThe study drug is a tablet called miricorilant. It belongs to a class of drugs called "Selective Glucocorticoid Receptor Modulators (SGRMs).” Modulation of cortisol with an SGRM may reduce liver fat. To learn if miricorilant will work to reduce liver fat as expected, participants will be randomly assigned to receive either miricorilant or placebo that does not contain medicine. Neither you nor the study staff will know your assignment.
For every 3 participants, 2 will receive miricorilant, and 1 will receive placebo. Therefore, you have a 66% chance of receiving the study drug.
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like MONARCH.
It is the liver’s job to filter and remove toxins from the blood and digest fats. When the liver is not working properly, it can cause a buildup of fat leading to a condition known as steatotic (fatty) liver disease.
If this excess fat buildup is caused by factors other than heavy alcohol use, it is referred to as metabolic dysfunction-associated steatotic liver disease (MASLD), also known as nonalcoholic fatty liver disease (NAFLD). It is estimated that 25% of the US population has MASLD/NAFLD. The specific cause of MASLD is unknown, but those who are most susceptible to developing MASLD are individuals with Type 2 Diabetes and those who are overweight or obese.
When MASLD progresses to the point of inflammation and liver damage, this is known as Metabolic dysfunction-Associated Steatohepatitis (MASH), also known as Nonalcoholic Steatohepatitis (NASH); Steato meaning “from fat” and hepatitis meaning “liver inflammation”. Of the 25% of the US population that has MASLD, about 20% of them develop MASH.
If allowed to progress, MASH/NASH can cause scarring of the liver tissue (fibrosis) leading to severe scarring (cirrhosis) and liver failure. MASH is considered a silent disease because most individuals do not notice symptoms until they have developed cirrhosis.
Cleveland Clinic. (2022). Non-Alcohol Related Steatohepatitis. Cleveland Clinic, Health Library. Retrieved November 10, 2023, from Non-Alcohol Related Steatohepatitis: What It Is, Causes & Treatment (clevelandclinic.org).
National Institute of Diabetes and Digestive and Kidney Diseases. (2021). Definition & Facts of NAFLD & NASH. U.S. Department of Health and Human Services, National Institutes of Health. Retrieved November 10, 2023, from Definition & Facts of NAFLD & NASH - NIDDK (nih.gov).
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Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
If you have additional questions about participating in a clinical research study, contact a study clinic near you.
Use the filters, map, and listing to find the study clinic closest to you. Contact the study clinic to learn more.