A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Interventions
- Registration Number
- NCT05117489
- Lead Sponsor
- Corcept Therapeutics
- Brief Summary
This phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)
- Detailed Description
This phase 1b, Open-Label Study will assess the safety, efficacy and pharmacokinetics (PK) of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH).
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Have a diagnosis of NASH based on a biopsy obtained within the last year OR Have a diagnosis of presumed NASH based on blood tests and scans
- Have participated in another clinical trial within the last year and received active treatment for NASH
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 3 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MWF for 10 weeks Miricorilant 100 mg 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 1 - 150 mg of miricorilant for 24 weeks Miricorilant 150 mg 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 Miricorilant 150 mg 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 4 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MF for 10 weeks Miricorilant 100 mg 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 Miricorilant 100 mg 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 Miricorilant 100 mg 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 10 - 200 mg of miricorilant once a week for 12 weeks Miricorilant 50 mg 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 Miricorilant 50 mg 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 7 - 50 mg of miricorilant daily for 12 weeks Miricorilant 50 mg 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 Miricorilant 50 mg 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 Miricorilant 10 mg 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.
- Primary Outcome Measures
Name Time Method Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline. Baseline Day 1 up to Week 24
- Secondary Outcome Measures
Name Time Method Change from Baseline in aspartate aminotransferase (AST). Baseline Day 1 up to Week 24 Change from Baseline in alanine aminotransferase (ALT). Baseline Day 1 up to Week 24 Change from Baseline in gamma-glutamyl transferase (GGT). Baseline Day 1 up to Week 24 Change from baseline in enhanced liver fibrosis score (ELF). Baseline Day 1 up to Week 24 ELF numerical values are calculated from serum measurements of hyaluronic acid (HA), tissue inhibitor of metalloproteinases-1 (TIMP-1), and type III procollagen (PIIINP) using the formula: ELF score = 2.494 + 0.846 In \[HA\] + 0.735 In \[PIIINP\] + 0.391 In \[TIMP-1\], and range on a continuous scale. Liver fibrosis is unlikely with scores \<6.7 and increasingly likely with higher scores.
Trial Locations
- Locations (9)
Site 207
🇺🇸Chandler, Arizona, United States
Site 214
🇺🇸Panorama City, California, United States
Site 211
🇺🇸Austin, Texas, United States
Site 233
🇺🇸Santa Ana, California, United States
Site 213
🇺🇸Edinburg, Texas, United States
Site 209
🇺🇸Tucson, Arizona, United States
Site 305
🇺🇸Houston, Texas, United States
Site 212
🇺🇸San Antonio, Texas, United States
226
🇺🇸Seattle, Washington, United States