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Also known as CORT118335 Oral, Miricorilant, Miricorilant (Cohort A), Miricorilant (Cohort B), Miricorlilant
CORT118335 · 9 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. |
| Miricorlilant 600 mg | EXPERIMENTAL | Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks. |
| Miricorlilant 900 mg | EXPERIMENTAL | Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks. |
| Placebo | PLACEBO_COMPARATOR | Patients who meet the entry criteria will be randomized to receive placebo for 26 weeks. |
| Miricorilant 600 mg | EXPERIMENTAL | Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant 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 |
| Miricorlilant | DRUG | Miricorilant 600 mg (4 X 150 mg) for once-daily for oral dosing |
| Placebo | DRUG | Placebo for once-daily oral dosing |
| Miricorilant | DRUG | Miricorilant 600 mg (6 X 100 mg 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...
CORT118335 is an oral small molecule drug developed by Corcept Therapeutics Incorporated for antipsychotic-induced weight gain. It has been studied in a Phase 1 clinical trial in the United Kingdom. It is an investigational agent and is not approved for any indication.
CORT118335 is being developed for antipsychotic-induced weight gain, a metabolic side effect associated with antipsychotic medications such as olanzapine. The clinical program has focused on this psychiatry-related indication. It remains investigational and has not been approved for use in this or any other condition.
CORT118335 is developed by Corcept Therapeutics Incorporated, a company listed on the Nasdaq under the ticker CORT. Corcept is the sponsor of the clinical program evaluating the drug for antipsychotic-induced weight gain.
CORT118335 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The drug is investigational and has not received FDA approval for antipsychotic-induced weight gain or any other indication.
CORT118335 has been evaluated in one completed Phase 1 trial, NCT03877562, titled "The Effect of CORT118335 on Olanzapine-Induced Weight Gain." The trial enrolled 96 healthy male volunteers aged 18 years and older in the United Kingdom and was randomized, double-blind, and placebo-controlled.