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Also known as Miricorilant (Cohort A)
Miricorilant · 7 trials · 9 indications
Time to maximum concentration (Tmax)
| Arm | Type | Description |
|---|---|---|
| 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. |
| Cohort 1: Miricorilant 900 mg (Regimen A1) | EXPERIMENTAL | Participants will receive a single oral dose of miricorilant 900 mg (3 X 300 mg) after breakfast on Day 1. Cohort 1 treatment will be randomized and open label. |
| Cohort 1: Miricorilant 300 mg (Regimen A2) | EXPERIMENTAL | Participants will receive a single oral dose of miricorilant 300 mg (2 X 150 mg) after breakfast on Day 1. Cohort 1 treatment will be randomized and open label. |
| Cohort 2: Miricorilant (Regimen B1 and B2) | EXPERIMENTAL | Participants will receive a single oral dose of miricorilant 900 mg (6 X 150 mg) after breakfast on Day 1 (Regimen B1). After a minimum 7-day washout, participants will receive miricorilant 900 mg (6 X 150 mg) qd for 14 days (Regimen B2). Day 1 treatment in Regimen B2 will be in the fasted state; the remaining doses will follow breakfast. Cohort 2 treatments will be randomized and blinded. |
| Cohort 2: Placebo (Regimen B1 and B2) | PLACEBO_COMPARATOR | Participants will receive a single oral dose of placebo matching miricorilant 900 mg (6 X 150 mg) after breakfast on Day 1 (Regimen B1). After a minimum 7-day washout, participants will receive placebo matching miricorilant 900 mg (6 X 150 mg) qd for 14 days (Regimen B2). Day 1 treatment in Regimen B2 will be in the fasted state; the remaining doses will follow breakfast. Cohort 2 treatments will be randomized and blinded. |
| Cohort 3: Miricorilant (Regimen C1 and C2) | EXPERIMENTAL | Participants will receive two oral doses (morning and evening) of miricorilant 1350 mg (9 X 150 mg) after a meal on Day 1 (Regimen C1). After a minimum 7-day washout, participants will receive miricorilant 750 mg (5 X 150 mg) after breakfast for 14 days and miricorilant 600 mg (4 X 150 mg) in the evening after a meal for 13 days (Regimen C2). Cohort 3 treatments will be randomized and blinded. |
| Cohort 3: Placebo (Regimen C1 and C2) | PLACEBO_COMPARATOR | Participants will receive two oral doses (morning and evening) of placebo matching miricorilant 1350 mg (9 X 150 mg) after a meal on Day 1 (Regimen C1). After a minimum 7-day washout, participants will receive placebo matching miricorilant 750 mg (5 X 150 mg) after breakfast for 14 days and placebo matching miricorilant 600 mg (4 X 150 mg) in the evening after a meal for 13 days (Regimen C2). Cohort 3 treatments will be randomized and blinded. |
| Name | Type | Description |
|---|---|---|
| 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. |
| Miricorilant 300 mg tablets | DRUG | Miricorilant 300 mg tablets for oral administration |
| Miricorilant 150 mg tablets | DRUG | Miricorilant 150 mg tablets for oral administration |
| Placebo 150 mg tablets | DRUG | Placebo to match miricorilant 150 mg tablets for oral administration |
Inclusion Criteria: * Have a diagnosis of schizophrenia or bipolar disorder * Are currently taking oral or injectable atypical antipsychotic medication (except clozapine) and must have documented weight gain while on these medications * Must be on a stable dose of medication for 1 month prior to Sc...
Miricorilant is an investigational small molecule being studied for metabolic conditions including Nonalcoholic Steatohepatitis (NASH), also known as Metabolic Dysfunction-Associated Steatohepatitis (MASH), as well as Antipsychotic-Induced Weight Gain (AIWG). It is in Phase 1 clinical development and is not approved by the FDA.
Miricorilant is being developed by Corcept Therapeutics Incorporated, a biopharmaceutical company traded on NASDAQ under the ticker CORT. The company is conducting Phase 1 clinical trials of Miricorilant in the United States for metabolic indications including NASH and antipsychotic-induced weight gain.
Miricorilant is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The development program includes completed and ongoing Phase 1 trials evaluating safety, pharmacokinetics, and effects on liver fat in patients with NASH and related metabolic conditions.
Miricorilant has been studied in several Phase 1 trials. NCT05117489 evaluated safety and efficacy in NASH patients. NCT05712265 studied effects of a CYP2C19 inhibitor on Miricorilant pharmacokinetics. NCT06947304 is evaluating effects on liver fat in MASLD patients. NCT07553663 is recruiting to evaluate pharmacokinetics and safety.
Yes, Miricorilant is also known as Miricorilant (Cohort A). This alternative name refers to the same investigational drug being developed by Corcept Therapeutics for metabolic conditions such as Nonalcoholic Steatohepatitis (NASH) and Antipsychotic-Induced Weight Gain.
Miricorilant is a small molecule being developed for metabolic diseases. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied for its effects on liver fat and metabolic parameters in conditions like NASH and antipsychotic-induced weight gain.