Nonalcoholic Steatohepatitis (NASH)Phase 1NCT07553663
Evaluating the Pharmacokinetics and Safety of Miricorilant
A Phase 1 study testing Miricorilant in people with Nonalcoholic Steatohepatitis (NASH) and Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis, run by Corcept Therapeutics at 1 site in United States.
Trial summary
A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis, Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
- What is being tested?
- Miricorilant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2026to 22 Sep 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of presumed MASH with either FibroScan liver stiffness measurement ≥ 8 kPa and controlled attenuation parameter (CAP) ≥ 280 dB/m OR historical biopsy within 12 months of screening that meets the following criteria:
- Nonalcoholic fatty liver disease (NAFLD) activity score (NAS) ≥ 3 with at least ≥ 1 point in any two subcomponents of steatosis, inflammation, and ballooning, and a Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) fibrosis score of F1 OR
- NAS ≥ 2 with at least ≥ 1 point in any two subcomponents of steatosis, inflammation, and ballooning, and a NASH CRN fibrosis score of F2 or 3.
- Aspartate aminotransferase (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.
- Presence of at least 1 of the following metabolic conditions that increase the risk of MASH:
- Diagnosis of type 2 diabetes OR
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- Presence of 2 or more components of metabolic syndrome:
- Fasting blood glucose ≥ 100 mg/dL (5.6 mmol/L) or treatment for elevated blood glucose
- Systolic blood pressure ≥ 130 mm Hg, diastolic blood pressure ≥ 85 mm Hg, or treatment for hypertension
- Serum triglycerides ≥ 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides
- Serum high-density lipoprotein (HDL) cholesterol < 40 mg/dL (1 mmol/L) in men and < 50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL
- Overweight or obese (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).
Who cannot join
- Women who are pregnant, planning to become pregnant, or are lactating.
- Have a BMI < 18 kg/m2 or > 45 kg/m2.
- Have significant alcohol consumption of more than 20 g per day for women and 30 g per day for men within 1 year prior to screening or score of ≥8 on AUDIT questionnaire
- Have had liver transplantation or plan to have liver transplantation during the study.
- Have type 1 diabetes.
- Have poorly controlled type 2 diabetes with a glycated hemoglobin (HbA1c)
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- 9.5%.
- Have any other chronic liver disease
- History of cirrhosis or evidence of cirrhosis by clinical, imaging, or liver biopsy evaluation
- Have hepatic decompensation
- Other exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Read the detailed description
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).
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis, Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), Non-alcoholic Fatty Liver Disease (NAFLD)
- Being tested
- Miricorilant
- Keywords
- Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH), Metabolic dysfunction-Associated Steatohepatitis (MASH), Metabolic dysfunction-Associated Steatosis Liver Disease (MASLD)
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiricorilantDrug
Single dose of 60 mg miricorilant
| Study group | Role | What they receive |
|---|---|---|
| Miricorilant 60mg | Experimental | Patients who meet the entry criteria for study CORT118335-863 will be administered a single dose of 60 mg miricorilant. Receives: Drug: Miricorilant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of miricorilant PK parameters
Time to maximum concentration (Tmax)
Measured: Day 1- Day 4
Assessment of miricorilant PK parameters
Maximum concentration over the dosing interval (Cmax)
Measured: Day 1 - Day 4
Assessment of miricorilant PK parameters
Concentration at 24 hours post-dose (C24)
Measured: 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))
Measured: 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))
Measured: Day 1 - Day 4
Assessment of miricorilant PK parameters
Area under the concentration-time curve from time zero extrapolated to infinity (AUC(0-inf)),
Measured: 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))
Measured: Day 1 - Day 4
Assessment of miricorilant PK parameters
Apparent terminal elimination half-life (T1/2)
Measured: Day 1 - Day 4
Secondary outcomes (1)
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.
Measured: Day 1- Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start30 Apr 2026
- Primary completion22 Sep 2026
- Study completion22 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Steatohepatitis (NASH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aprille Espinueva, PharmD, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553663
- Sponsor's protocol ID
- CORT118335-863
- Status last verified
- Oct 2026
- First submitted
- 14 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No