A Phase 1 interventional study of Miricorilant in Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis and Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), sponsored by Corcept Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Corcept Therapeutics · Phase 1, Interventional, and Treatment
A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Approximately 15 patients who are eligible for participation in the study will be administered a single dose of 60 mg of miricorilant. The maximum expected duration of a patient's participation is 56 days (up to 28 days of screening, followed by single-dose administration and 4 days of observation, and then 24 days of follow-up).
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's enrollment of 14 is below the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Corcept Therapeutics is the lead sponsor of 73 studies on the registry; 3 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 9 (28%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Evidence of presumed MASH with either FibroScan liver stiffness measurement ≥ 8 kPa and controlled attenuation parameter (CAP) ≥ 280 dB/m OR historical within 12 months of screening that meets the following criteria:
Presence of at least 1 of the following metabolic conditions that increase the risk of MASH:
Presence of 2 or more components of metabolic syndrome:
Exclusion Criteria:
Have poorly controlled type 2 diabetes with a (HbA1c)
Other exclusion criteria may apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who meet the entry criteria for study CORT118335-863 will be administered a single dose of 60 mg miricorilant.
Drug: Miricorilant
Single dose of 60 mg miricorilant
Assessment of miricorilant PK parameters
Time to maximum concentration (Tmax)
Time frame: Day 1- Day 4
Assessment of miricorilant PK parameters
Maximum concentration over the dosing interval (Cmax)
Time frame: Day 1 - Day 4
Assessment of miricorilant PK parameters
Concentration at 24 hours post-dose (C24)
Time frame: Day 1 - Day 4
Assessment of miricorilant PK parameters
Area under the concentration-time curve from time 0 to time of last measurable concentration (AUC(0-last))
Time frame: Day 1 - Day 4
Assessment of miricorilant PK parameters
Area under the concentration-time curve from time 0 to time 24 hours post-dose (AUC(0-24))
Time frame: Day 1 - Day 4
Assessment of miricorilant PK parameters
Area under the concentration-time curve from time zero extrapolated to infinity (AUC(0-inf)),
Time frame: Day 1 - Day 4
Assessment of miricorilant PK parameters
Partial areas under the concentration-time curve from time 0 to time 6 hours and/or 8 hours post-dose (AUC(0-6), AUC(0-8))
Time frame: Day 1 - Day 4
Assessment of miricorilant PK parameters
Apparent terminal elimination half-life (T1/2)
Time frame: Day 1 - Day 4
Incidence of adverse events (AEs), serious adverse events (SAEs), clinical laboratory evaluations, (hematology, clinical chemistry, urinalysis), 12-lead electrocardiograms (ECGs), vital sign measurements and physical examinations.
Time frame: Day 1- Day 28
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: CORT118335
Non-alcoholic Fatty Liver Disease →