Actively Recruiting
A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Led by Corcept Therapeutics · Updated on 2026-05-26
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the drug miricorilant in adults with presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH), a liver condition related to metabolic dysfunction. This Phase 1b open-label trial aims to evaluate how the body processes miricorilant and assess its safety in these patients. Participants will receive a single 60 mg dose of miricorilant. The study includes up to 28 days of screening, followed by the dose administration and 4 days of close observation. After that, there is a 24-day follow-up period to monitor participants. During the study, researchers will measure how miricorilant is absorbed and processed from Day 1 to Day 4. They will also monitor for any side effects, perform lab tests including blood, urine, and heart monitoring, and conduct physical exams through Day 28. Total participation can last up to 56 days.
CONDITIONS
Brief Title
Evaluating the Pharmacokinetics and Safety of Miricorilant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Evidence of presumed MASH with either FibroScan liver stiffness 63 8 kPa and CAP 63 280 dB/m or a historical biopsy within 12 months meeting specific NAFLD activity and fibrosis scores
- Aspartate aminotransferase (AST) > 17 U/L for women and > 20 U/L for men, unless an eligible biopsy is available
- Presence of type 2 diabetes or at least two metabolic syndrome factors such as elevated fasting glucose, high blood pressure, high triglycerides, low HDL cholesterol, or overweight/obesity
You will not qualify if you...
- Women who are pregnant, planning to become pregnant, or breastfeeding
- Body mass index (BMI) less than 18 kg/m2 or greater than 45 kg/m2
- Significant alcohol consumption exceeding 20 g/day for women or 30 g/day for men within the past year or AUDIT score 63 8
- History of or planned liver transplantation during the study
- Type 1 diabetes or poorly controlled type 2 diabetes with HbA1c 63 9.5%
- Any other chronic liver disease or evidence/history of cirrhosis or hepatic decompensation
- Other exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 28 days
Participants are screened for eligibility to participate in the trial.
Duration - 4 days
Participants receive a single dose of 60 mg miricorilant and are observed for safety and pharmacokinetics.
1 treatment visit with observation over 4 days
Duration - 24 days
Participants are monitored for safety and adverse events after treatment.
Periodic follow-up visits up to 24 days after treatment
Trial Site Locations
Total: 1 location
1
Site# 433
San Antonio, Texas, United States, 78215
Actively Recruiting
Research Team
E
Eric Lawitz, MD
T
Toluwalase Okubote, MBBS, MPH, PMP
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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