Evaluation of Miricorilant on Liver Fat in Patients With MASLD

NCT06947304 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CORT118335-858
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Conditions

Nonalcoholic Steatohepatitis (NASH); Metabolic Dysfunction-Associated Steatohepatitis (MASH); Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD); Non-alcoholic Fatty Liver Disease (NAFLD)

Keywords

Nonalcoholic Fatty Liver Disease (NAFLD); Nonalcoholic Steatohepatitis (NASH); Metabolic dysfunction-Associated Steatohepatitis (MASH); Metabolic dysfunction-Associated Steatosis Liver Disease (MASLD)

Outcome Measures

Primary Outcomes (2)

• Change in fasting hepatic lipogenesis after 6 weeks of treatment

  Baseline to Week 6

• Change in peak lipogenesis after 6 weeks of treatment.

  Baseline to Week 6

Secondary Outcomes (1)

• Change in liver fat content by MRI-PDFF after 6 weeks of treatment

  Baseline to week 6

Study Arms (1)

Miricorilant- 100 mg

EXPERIMENTAL

Patients who meet the entry criteria for study CORT118335-858 will be enrolled to receive 100 mg of miricorilant every day for 6 weeks.

Drug: Miricorilant

Interventions

Miricorilant DRUG

100 mg administered orally, once daily

Miricorilant- 100 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[BMI
• kg/m2 in Asians\]), 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).

You may not qualify 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 \< 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).

Sponsors & Collaborators

• Corcept Therapeutics: lead
• University of Missouri-Columbia: collaborator

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Kavita Juneja, MD

  Corcept Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Elizabeth Parks, PhD

CONTACT

(573) 882-5864; parksej@missouri.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 27, 2025
• Study Start: August 22, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)