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Also known as Miricorilant (Cohort A), CORT118335
Miricorilant · 8 trials · 9 indications
Time to maximum concentration (Tmax)
| Arm | Type | Description |
|---|---|---|
| Experimental (Cohort A) | EXPERIMENTAL | Patients who meet the entry criteria for study CORT118335-862 (Cohort A) will be enrolled to receive 100 mg of miricorilant, twice a week for 48 weeks. |
| Placebo (Cohort A) | PLACEBO_COMPARATOR | Patients who meet the entry criteria for study CORT118335-862 (Cohort A) will be enrolled to receive a matching placebo twice a week for 48 weeks. |
| Placebo (Cohort B) | PLACEBO_COMPARATOR | Patients who meet the entry criteria for study CORT118335-862 (Cohort B) will be enrolled to receive a matching placebo twice a week for 24 weeks. |
| Experimental (Cohort B) | EXPERIMENTAL | Patients who meet the entry criteria for study CORT118335-862 (Cohort B) will be enrolled to receive 100 mg of miricorilant, twice a week for 6 weeks. Dose will be escalated to 200 mg of miricorilant, twice a week for 18 weeks. |
| Miricorilant 600 mg | EXPERIMENTAL | Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks. |
| Miricorilant 60mg | EXPERIMENTAL | Patients who meet the entry criteria for study CORT118335-863 will be administered a single dose of 60 mg miricorilant. |
| Miricorilant- 100 mg | EXPERIMENTAL | Patients who meet the entry criteria for study CORT118335-858 will be enrolled to receive 100 mg of miricorilant every day for 6 weeks. |
| Miricorilant - Fluvoxamine/Miricorilant | EXPERIMENTAL | Participants will receive a single oral dose of miricorilant 600 mg on Days 1 and 10 and a single oral dose of fluvoxamine 50 mg on Days 4 to 12. |
| No Hepatic Impairment | EXPERIMENTAL | Participants will receive a single oral dose of miricorilant (6 X100 mg) tablets. |
| Moderate Hepatic Impairment | EXPERIMENTAL | Participants will receive a single oral dose of miricorilant (6 X100 mg) tablets. |
| Mild Hepatic Impairment | EXPERIMENTAL | Participants will receive a single oral dose of miricorilant (6 X100 mg) tablets. |
| Cohort 1 - 150 mg of miricorilant for 24 weeks | EXPERIMENTAL | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg once daily, for 24 weeks. |
| Cohort 2 - 150 mg of miricorilant for 12 weeks | EXPERIMENTAL | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg once daily, for 12 weeks. |
| Cohort 3 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MWF for 10 weeks | EXPERIMENTAL | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily for 2 weeks, followed by 100 mg of miricorilant every Monday, Wednesday and Friday for 10 weeks. |
| Cohort 4 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MF for 10 weeks | EXPERIMENTAL | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily, for 2 weeks, followed by 100 mg of miricorilant every Monday and Friday for 10 weeks. |
| Cohort 5 - 100 mg of miricorilant every MWF for 12 weeks | EXPERIMENTAL | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant of 100 mg every Monday, Wednesday and Friday for 12 weeks. |
| Cohort 6 - 100 mg of miricorilant every MF for 12 weeks | EXPERIMENTAL | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant of 100 mg every Monday and Friday for 12 weeks. |
| Cohort 7 - 50 mg of miricorilant daily for 12 weeks | EXPERIMENTAL | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 50 mg once daily, for 12 weeks. |
| Cohort 8 - 100 mg of miricorilant daily for 12 weeks | EXPERIMENTAL | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily, for 12 weeks. |
| Cohort 9 - 30 mg of miricorilant daily for 12 weeks | EXPERIMENTAL | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 30 mg once daily, for 12 weeks. |
| Cohort 10 - 200 mg of miricorilant once a week for 12 weeks | EXPERIMENTAL | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 200 mg once weekly, for 12 weeks. |
| Cohort 11 - 150 mg of miricorilant twice weekly for 12 weeks | EXPERIMENTAL | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg twice weekly for 12 weeks. |
| Olanzapine plus CORT118335 | EXPERIMENTAL | Participants will receive olanzapine 10 mg oral tablets and double-blind CORT118335 600 mg after breakfast once daily for 14 days. |
| Olanzapine plus Placebo | PLACEBO_COMPARATOR | Participants will receive olanzapine 10 mg oral tablets and double-blind placebo matching CORT118335 oral tablets after breakfast once daily for 14 days. |
| Name | Type | Description |
|---|---|---|
| Miricorilant (Cohort A) | DRUG | Miricorilant 100 mg for oral dosing |
| Placebo (Cohort A) | DRUG | Matching placebo for oral dosing for 48 Weeks |
| Miricorilant (Cohort B) | DRUG | Miricorilant 100 mg for oral dosing Miricorilant 200 mg for oral dosing |
| Placebo (Cohort B) | DRUG | Matching placebo for oral dosing for 24 Weeks |
| Miricorilant | DRUG | Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing |
| Placebo | DRUG | Placebo tablets for once-daily oral dosing |
| Fluvoxamine | DRUG | Fluvoxamine 50 mg tablet |
| Miricorilant 150 mg | DRUG | Miricorilant 150 mg for oral dosing |
| Miricorilant 100 mg | DRUG | Miricorilant 100 mg for oral dosing |
| Miricorilant 50 mg | DRUG | Miricorilant 50 mg for oral dosing |
| Miricorilant 10 mg | DRUG | Miricorilant 10 mg for oral dosing. |
| Olanzapine | DRUG | Olanzapine 10 mg oral tablet |
| CORT118335 | DRUG | CORT118335 600 mg oral tablets administered as 2 X 300 mg or 6 X 100 mg tablets |
Inclusion Criteria: * Cohort A: Histological diagnosis of NASH/MASH with NAS ≥ 4 (≥ 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH-CRN fibrosis score of 2 or 3 based on the consensus method of histological assessment. A historical liver biopsy within 6 months of S...
Miricorilant is an investigational small molecule developed by Corcept Therapeutics for metabolic conditions, including nonalcoholic steatohepatitis (NASH), also called metabolic dysfunction-associated steatohepatitis (MASH), and antipsychotic induced weight gain. It has been studied in Phase 1 and Phase 2 clinical trials.
Miricorilant targets the glucocorticoid receptor (GR). It is a small molecule designed to act on GR, a receptor involved in metabolic regulation. Corcept Therapeutics is developing miricorilant around this GR mechanism for metabolic indications such as NASH and MASH.
Miricorilant is developed by Corcept Therapeutics Incorporated, which trades under the ticker CORT. The company has sponsored the clinical trial program for miricorilant, including Phase 1 pharmacokinetic studies and a Phase 2b study in NASH and MASH.
Miricorilant is in Phase 2 development. Its largest study, the Phase 2b MONARCH trial in NASH and MASH, has been completed. Miricorilant is investigational and has not been established as approved for any indication based on the completed trials.
Miricorilant has been studied in four completed trials. These include the Phase 2b MONARCH study (NCT06108219) in NASH and MASH, a Phase 1 liver fat study in MASLD (NCT06947304), a Phase 1 pharmacokinetic and safety study (NCT07553663), and a Phase 1 drug interaction study (NCT05712265).