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Miricorilant Treatment A

Phase 1

Healthy | Small molecule | Other |Corcept Therapeutics Incorporated|Last Updated: Apr 13, 2026

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07240116Study Evaluating the Bioavailability of Miricorilant With Optional Food Effect Assessment in Healthy Adult SubjectsPHASE1 COMPLETED 18 — — Sep 11, 2025Mar 3, 2026Apr 13, 20261 United States
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Study Endpoints
Primary Endpoints
Time of Maximum Observed Concentration (Tmax) of Miricorilant
Predose and at serial timepoints up to 72 hours postdose
Maximum Observed Concentration (Cmax) of Miricorilant
Predose and at serial timepoints up to 72 hours postdose
Concentration at 24 Hours Postdose (C24) of Miricorilant
Predose and at serial timepoints up to 24 hours postdose
Area Under the Curve from Time 0 to the Time of Last Measurable Concentration (AUC[0-last]) of Miricorilant
Predose and at serial timepoints up to 72 hours postdose
Area Under the Curve from Time 0 Extrapolated to Infinity (AUC[0-inf]) of Miricorilant
Predose and at serial timepoints up to 72 hours postdose
Terminal Elimination Half-Life (T1/2) of Miricorilant
Predose and at serial timepoints up to 72 hours postdose
Relative Bioavailability (Frel) for Miricorilant Based on Cmax
Predose and at serial timepoints up to 72 hours postdose
Frel for Miricorilant based on AUC(0-last)
Predose and at serial timepoints up to 72 hours postdose
Frel for Miricorilant Based on AUC(0-inf)
Predose and at serial timepoints up to 72 hours postdose
Secondary Endpoints
Number of Participants with Abnormal, Clinically Significant Clinical Laboratory Findings
Day -1 and 72 hours postdose in periods 3 and 4
Number of Participants with Abnormal, Clinically Significant 12-Lead Electrocardiogram (ECG) Findings
Day -1, predose, and at 4 and 72 hours postdose in every study period
Number of Participants with Abnormal, Clinically Significant Vital Sign Findings
Day -1, predose, and at serial time points up to 72 hours postdose in every study period
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Miricorilant Treatment Sequence A, B, CEXPERIMENTALParticipants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment A; in Period 2, treatment B; in Period 3, treatment C. A washout period of at least 7 days will follow each dose of the study drug.
Miricorilant Treatment Sequence B, C, AEXPERIMENTALParticipants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment B, in Period 2, treatment C; in Period 3, treatment A. A washout period of at least 7 days will follow each dose of the study drug.
Miricorilant Treatment Sequence C, A, BEXPERIMENTALParticipants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment C; in Period 2, treatment A; in Period 3, treatment B. A washout period of at least 7 days will follow each dose of the study drug.
Miricorilant Treatment Sequence B, A, CEXPERIMENTALParticipants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment B; in Period 2, treatment A; in Period 3, treatment C. A washout period of at least 7 days will follow each dose of the study drug.
Miricorilant Treatment Sequence A, C, BEXPERIMENTALParticipants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment A; in Period 2, treatment C; in Period 3, treatment B. A washout period of at least 7 days will follow each dose of the study drug.
Miricorilant Treatment Sequence C, B, AEXPERIMENTALParticipants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment C; in Period 2, treatment B; in Period 3, treatment A. A washout period of at least 7 days will follow each dose of the study drug.
Optional Miricorilant Treatment DEXPERIMENTALAfter completion of Period 3, analysis of pharmacokinetic and safety data will be used to decide if Period 4 will be conducted. In Period 4, selected participants will receive a single dose of treatment D in a fasted state on Day 1.
Interventions
NameTypeDescription
Miricorilant Treatment ADRUGMiricorilant 100 mg (1 x 100 mg) Kinetisol immediate release (IR) tablet for oral administration
Miricorilant Treatment BDRUGMiricorilant 100 mg (2 x 50 mg) Kinetisol IR tablet for oral administration
Miricorilant Treatment CDRUGMiricorilant 100 mg (2 x 50 mg) SDD IR tablet for oral administration
Miricorilant Treatment DDRUGMiricorilant 100 mg (1 x 100 mg or 2 x 50 mg) Kinetisol IR tablet for oral administration. The tablet strength administered will be decided after Period 3 is complete.
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Able to understand written informed consent * Willing and able to comply with study requirements * Willing to comply with protocol-specified contraception requirements * Healthy male or non-pregnant, non-lactating female of non-childbearing potential per Investigator assessmen...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT07240116TRIAL_REMOVED: changed
LOWMay 24, 2026NCT07240116studyFirstPostDate: changed