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Miricorilant for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

This study is looking at how your body processes a single dose of 60 mg of miricorilant and if it is safe for people with certain liver conditions. These conditions include Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH), or other related fatty liver diseases. We are studying miricorilant's pharmacokinetics (how the body absorbs, distributes, metabolizes, and excretes a drug) and safety. To join, you should be between 18 and 75 years old and have evidence of presumed MASH, possibly shown by a FibroScan liver stiffness measurement or a recent liver biopsy. The study aims to understand how the drug moves through your body over four days after you take it. The current recruitment status is unclear.

Study design
This is a Phase 1b, open-label study, meaning both you and the study team will know you are receiving miricorilant. Approximately 15 adult patients will participate.
What's involved
You would receive a single dose of 60 mg of miricorilant. Your total participation could last up to 56 days, including screening, the dose administration, 4 days of observation, and 24 days of follow-up.
Compensation
Not stated in the trial record.
Follow-up
After receiving the single dose, you would be observed for 4 days, followed by a 24-day follow-up period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07553663

Evaluating the Pharmacokinetics and Safety of Miricorilant

Recruiting
PHASE1Ages 18–75InterventionalTreatment
Corcept Therapeutics
~15 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:Miricorilant

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment of miricorilant PK parameters
Measured over Day 1- Day 4
+7 more outcomes measured

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)

Explore related trials

Nonalcoholic Fatty Liver DiseaseNonalcoholic Steatohepatitis

NCT07553663

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Site# 433

    San Antonio, Texasno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Aprille Espinueva, PharmD · STUDY_DIRECTOR · Corcept Therapeutics

Who to contact

Eric Lawitz, MD
[email protected]
210-253-3426
Email the study team

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Eligibility criteria

Inclusion

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:
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:
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).

Exclusion

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)
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

What this trial measures

  • Assessment of miricorilant PK parametersDay 1- Day 4

    Time to maximum concentration (Tmax)

  • Assessment of miricorilant PK parametersDay 1 - Day 4

    Maximum concentration over the dosing interval (Cmax)

  • Assessment of miricorilant PK parametersDay 1 - Day 4

    Concentration at 24 hours post-dose (C24)

  • Assessment of miricorilant PK parametersDay 1 - Day 4

    Area under the concentration-time curve from time 0 to time of last measurable concentration (AUC(0-last))

  • Assessment of miricorilant PK parametersDay 1 - Day 4

    Area under the concentration-time curve from time 0 to time 24 hours post-dose (AUC(0-24))

  • Assessment of miricorilant PK parametersDay 1 - Day 4

    Area under the concentration-time curve from time zero extrapolated to infinity (AUC(0-inf)),

  • Assessment of miricorilant PK parametersDay 1 - Day 4

    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))

  • Assessment of miricorilant PK parametersDay 1 - Day 4

    Apparent terminal elimination half-life (T1/2)