Evaluation of Miricorilant on Liver Fat in Patients With MASLD
A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65211
- University of Missouri
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion 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 at least 1 month prior to screening) OR b. Presence of 3 or more components of metabolic syndrome: i. Fasting blood glucose ≥ 100 mg/dL (5.6 mmol/L) or treatment for elevated blood glucose with metformin ii. Systolic blood pressure ≥ 130 mm Hg, diastolic blood pressure ≥ 85 mm Hg, or treatment for hypertension iii. Serum TG ≥ 150 mg/dL (1.7 mmol/L) iv. Serum high-density lipoprotein cholesterol (HDL) < 40 mg/dL (1 mmol/L) in men and < 50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL v. Having overweight or obesity (body mass index [BMI] ≥ 25 kg/m2 [BMI
- 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 inclusion criteria may apply
Exclusion Criteria:
- 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 < 18 kg/m² or > 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Miricorilant- 100 mg
Patients who meet the entry criteria for study CORT118335-858 will be enrolled to receive 100 mg of miricorilant every day for 6 weeks.
|
100 mg administered orally, once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in fasting hepatic lipogenesis after 6 weeks of treatment
Time Frame: Baseline to Week 6
|
Baseline to Week 6
|
|
Change in peak lipogenesis after 6 weeks of treatment.
Time Frame: Baseline to Week 6
|
Baseline to Week 6
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in liver fat content by MRI-PDFF after 6 weeks of treatment
Time Frame: Baseline to week 6
|
Baseline to week 6
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Kavita Juneja, MD, Corcept Therapeutics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CORT118335-858
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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