A Phase 1b, Open-Label Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Adult Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 9
- 主要终点
- Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline.
研究概览
简要总结
This phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Miricorilant 150 mg (Drug)
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.
干预措施: Miricorilant 150 mg (Drug)
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.
干预措施: Miricorilant 100 mg (Drug)
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.
干预措施: Miricorilant 100 mg (Drug)
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.
干预措施: Miricorilant 100 mg (Drug)
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.
干预措施: Miricorilant 100 mg (Drug)
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.
干预措施: Miricorilant 50 mg (Drug)
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.
干预措施: Miricorilant 50 mg (Drug)
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.
干预措施: Miricorilant 10 mg (Drug)
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.
干预措施: Miricorilant 50 mg (Drug)
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.
干预措施: Miricorilant 50 mg (Drug)
结局指标
主要结局
Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline.
时间窗: Baseline Day 1 up to Week 24
次要结局
- 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)