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New treatment option for Nonalcoholic Steatohepatitis (NASH)
Official title Evaluation of Miricorilant on Liver Fat in Patients With MASLD
ClinicalTrials.gov ID: NCT06947304
What this study is testing
What is Miricorilant?
Miricorilant is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for nonalcoholic steatohepatitis (nash).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- AST \> 17 U/L for women and AST \> 20 U/L for men. The AST inclusion criterion does not apply to participants with an eligible historical liver...
- NAFLD Activity Score (NAS) ≥ 4 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH Clinical Research...
- NAS ≥ 3 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH CRN fibrosis score of F1 OR
- NAS ≥ 2 (with at least 1 point in subcomponent of ballooning or inflammation) and a NASH CRN fibrosis score of F2-3
- MRI-PDFF with ≥ 8% steatosis; this assessment must be performed within 4 weeks of the Baseline Visit.
You likely can't join if
- Participation in another clinical trial for MASH or weight loss (e.g., GLP-1 receptor agonists) within the last 3 months.
- Participation in any other clinical trial within the last 3 months or 5 half-lives of the treatment, whichever is longer.
- Women who are pregnant, planning to become pregnant, or lactating.
- BMI \ 45 kg/m².
- Significant alcohol consumption exceeding 20 g/day for women or 30 g/day for men within 1 year prior to screening.
- Positive urine drug screen for amphetamines, cocaine, opiates, or cannabinoids.
See the full eligibility criteria
- AST \> 17 U/L for women and AST \> 20 U/L for men. The AST inclusion criterion does not apply to participants with an eligible historical liver biopsy performed within 12 months of screening showing one of the following:
- NAFLD Activity Score (NAS) ≥ 4 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH Clinical Research Network (CRN) fibrosis score of F0 OR
- NAS ≥ 3 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH CRN fibrosis score of F1 OR
- NAS ≥ 2 (with at least 1 point in subcomponent of ballooning or inflammation) and a NASH CRN fibrosis score of F2-3
- MRI-PDFF with ≥ 8% steatosis; this assessment must be performed within 4 weeks of the Baseline Visit.
- Presence of at least 1 of the following metabolic syndrome characteristics that increase the risk of MASH: a. Diagnosis of type 2 diabetes managed with diet alone or diet and metformin (metformin dose must be stable for...
- 23 kg/m2 in Asians]), or increased waist circumference ≥ 102 cm (40 in) in men and ≥ 88 cm (35 in) in women (men ≥ 90 cm [35.4 in]; women ≥ 80 cm [31.5 in] in Asians). Other may apply
- Participation in another clinical trial for MASH or weight loss (e.g., GLP-1 receptor agonists) within the last 3 months.
- Participation in any other clinical trial within the last 3 months or 5 half-lives of the treatment, whichever is longer.
- Women who are pregnant, planning to become pregnant, or lactating.
- BMI \ 45 kg/m².
- Significant alcohol consumption exceeding 20 g/day for women or 30 g/day for men within 1 year prior to screening.
- Positive urine drug screen for amphetamines, cocaine, opiates, or cannabinoids.
- Known or suspected cirrhosis or signs of hepatic decompensation.
- Other chronic liver diseases such as hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, or Wilson's disease.
- History of myocardial infarction, unstable angina, or stroke within 3 months prior to screening.
- Uncontrolled hypertension (systolic \> 160 mm Hg or diastolic \> 100 mm Hg).
- Current use of medications prohibited due to potential drug-drug interactions with study treatment.
- Contraindications to magnetic resonance imaging (MRI). Other exclusion criteria may apply
The study team makes the final eligibility decision.
Where it's taking place
- Columbia, Missouri, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbia, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.