A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
NCT ID: NCT05117489
Last Updated: 2024-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
70 participants
INTERVENTIONAL
2021-11-23
2024-01-29
Brief Summary
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Detailed Description
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Patients who meet the criteria for the study CORT-118335-861 will be enrolled on Day 1 into 1 of 11 cohorts and receive:
* Cohort 1 - a daily dose of 150 mg of miricorilant over 24 weeks.
* Cohort 2 - a daily dose of 150 mg of miricorilant over 12 weeks.
* Cohort 3 - a daily dose of 100 mg of miricorilant over 2 weeks, followed by 10 weeks of dosing at 100 mg miricorilant every Monday, Wednesday and Friday.
* Cohort 4 - a daily dose of 100 mg of miricorilant over 2 weeks, followed by 10 weeks of dosing at 100 mg miricorilant every Monday and Friday.
* Cohort 5 - a thrice weekly dose of 100 mg of miricorilant over 12 weeks every Monday, Wednesday, and Friday.
* Cohort 6 - a twice weekly dose of 100 mg of miricorilant over 12 weeks every Monday and Friday.
* Cohort 7 - a daily dose of 50 mg of miricorilant over 12 weeks.
* Cohort 8 - a daily dose of 100 mg of miricorilant over 12 weeks.
* Cohort 9 - a daily dose of 30 mg of miricorilant over 12 weeks.
* Cohort 10 - a once weekly dose of 200 mg of miricorilant over 12 weeks.
* Cohort 11 - a twice weekly dose of 150 mg miricorilant over 12 weeks.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1 - 150 mg of miricorilant for 24 weeks
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.
Miricorilant 150 mg
Miricorilant 150 mg for oral dosing
Cohort 2 - 150 mg of miricorilant for 12 weeks
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.
Miricorilant 150 mg
Miricorilant 150 mg for oral dosing
Cohort 3 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MWF for 10 weeks
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.
Miricorilant 100 mg
Miricorilant 100 mg for oral dosing
Cohort 4 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MF for 10 weeks
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.
Miricorilant 100 mg
Miricorilant 100 mg for oral dosing
Cohort 5 - 100 mg of miricorilant every MWF for 12 weeks
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.
Miricorilant 100 mg
Miricorilant 100 mg for oral dosing
Cohort 6 - 100 mg of miricorilant every MF for 12 weeks
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.
Miricorilant 100 mg
Miricorilant 100 mg for oral dosing
Cohort 7 - 50 mg of miricorilant daily for 12 weeks
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.
Miricorilant 50 mg
Miricorilant 50 mg for oral dosing
Cohort 8 - 100 mg of miricorilant daily for 12 weeks
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.
Miricorilant 50 mg
Miricorilant 50 mg for oral dosing
Cohort 9 - 30 mg of miricorilant daily for 12 weeks
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.
Miricorilant 10 mg
Miricorilant 10 mg for oral dosing.
Cohort 10 - 200 mg of miricorilant once a week for 12 weeks
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.
Miricorilant 50 mg
Miricorilant 50 mg for oral dosing
Cohort 11 - 150 mg of miricorilant twice weekly for 12 weeks
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.
Miricorilant 50 mg
Miricorilant 50 mg for oral dosing
Interventions
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Miricorilant 150 mg
Miricorilant 150 mg for oral dosing
Miricorilant 100 mg
Miricorilant 100 mg for oral dosing
Miricorilant 50 mg
Miricorilant 50 mg for oral dosing
Miricorilant 10 mg
Miricorilant 10 mg for oral dosing.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Have participated in another clinical trial for any other indication within the last 3 months
* Are pregnant or lactating women
* Have a BMI \<18 kg/m2
* Have had liver transplantation or plan to have liver transplantation during the study
* Have type 1 diabetes or poorly controlled type 2 diabetes.
18 Years
75 Years
ALL
No
Sponsors
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Corcept Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Kavita Juneja, MD
Role: STUDY_DIRECTOR
Corcept Therapeutics
Locations
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Site 207
Chandler, Arizona, United States
Site 209
Tucson, Arizona, United States
Site 214
Panorama City, California, United States
Site 233
Santa Ana, California, United States
Site 211
Austin, Texas, United States
Site 213
Edinburg, Texas, United States
Site 305
Houston, Texas, United States
Site 212
San Antonio, Texas, United States
226
Seattle, Washington, United States
Countries
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Other Identifiers
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CORT118335-861
Identifier Type: -
Identifier Source: org_study_id
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