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Miricorilant

Phase 1

Non-alcoholic Steatohepatitis (NASH) | Small molecule | Infectious Disease |Corcept Therapeutics Incorporated|Last Updated: Mar 30, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment19
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05553470Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of MiricorilantPHASE1 COMPLETED 19 — — Mar 3, 2022Sep 13, 2024Mar 30, 20253 United States
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Study Endpoints
Primary Endpoints
Area under the Concentration-Time Curve (AUC) from Time Zero to the Last Non-Zero Concentration (AUC 0-t)
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hours post-dose
AUC from Time Zero to Infinity (AUC0-∞)
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hours post-dose
Maximum Observed Plasma Concentration (Cmax)
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hours post-dose
Secondary Endpoints
Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Up to Day 7
Number of Participants with One or More Serious Adverse Events (SAEs)
Up to 30 days after study drug administration
Number of Participants with Clinically-Significant Vital Sign Abnormality
Day -1, pre-dose and ~ 1, 2, 4, and 24 hours post-dose.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
No Hepatic ImpairmentEXPERIMENTALParticipants will receive a single oral dose of miricorilant (6 X100 mg) tablets.
Moderate Hepatic ImpairmentEXPERIMENTALParticipants will receive a single oral dose of miricorilant (6 X100 mg) tablets.
Mild Hepatic ImpairmentEXPERIMENTALParticipants will receive a single oral dose of miricorilant (6 X100 mg) tablets.
Interventions
NameTypeDescription
MiricorilantDRUG600 mg miricorilant
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Non-smoker or light smokers (no more than 5 cigarettes/day or nicotine equivalent) with BMI ≥18.0 and ≤32 kg/m2 and body weight ≥50.0 kg. * Female participants must be non-childbearing or willing to use an acceptable intra-uterine contraceptive device 4 weeks prior and through...

Countries:United States
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