Actively Recruiting
A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Led by Corcept Therapeutics · Updated on 2026-02-11
8
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Corcept Therapeutics
Lead Sponsor
U
University of Missouri-Columbia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of Miricorilant on liver fat and metabolism in patients with presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH), a condition related to fatty liver disease. This is a Phase 1, open-label study aiming to understand how Miricorilant influences liver fat production and storage in affected patients. About 8 patients will participate and receive 100 mg of Miricorilant orally once daily for 6 weeks. The total participation lasts up to 16 weeks, including a 6-week screening period before treatment, the 6-week treatment phase, and a 4-week follow-up period. The study does not include a placebo or comparison group. Participants will undergo assessments including MRI scans to measure liver fat content, and tests to evaluate changes in liver fat production before and after treatment. Researchers will monitor safety and treatment effects during and after the study. The primary outcomes focus on changes in hepatic lipogenesis and liver fat measured from baseline to week 6.
CONDITIONS
Brief Title
Evaluation of Miricorilant on Liver Fat in Patients With MASLD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- AST > 17 U/L for women and > 20 U/L for men, or eligible liver biopsy within 12 months showing specific NAS and fibrosis scores
- MRI-PDFF showing ≥ 8% liver steatosis within 4 weeks before baseline
- Presence of at least one metabolic syndrome characteristic such as type 2 diabetes managed with diet or metformin, or at least three components of metabolic syndrome including elevated blood glucose, hypertension, high triglycerides, low HDL cholesterol, overweight or increased waist circumference
- Other inclusion criteria may apply
You will not qualify if you...
- Participation in another clinical trial for MASH or weight loss within the last 3 months
- Participation in any other clinical trial within last 3 months or 5 half-lives of treatment
- Women who are pregnant, planning pregnancy, or lactating
- BMI less than 18 or greater than 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 liver decompensation
- Other chronic liver diseases like hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, or Wilson's disease
- History of recent myocardial infarction, unstable angina, or stroke within 3 months
- Uncontrolled hypertension above specified limits
- Current use of medications prohibited due to drug interactions with study treatment
- Contraindications to MRI
- Other exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 6 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 6 weeks
Participants receive 100 mg of miricorilant orally once daily for 6 weeks.
Weekly visits for up to 6 weeks
Duration - 4 weeks
Participants are monitored for safety and outcomes following treatment completion.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
University of Missouri
Columbia, Missouri, United States, 65211
Actively Recruiting
Research Team
E
Elizabeth Parks, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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