A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 15
- 主要终点
- Relative Change From Baseline in Liver Fat Content Assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction
研究概览
简要总结
This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant (CORT118335) in patients with presumed Nonalcoholic Steatohepatitis (NASH).
详细描述
This is a randomized, double-blind, placebo-controlled study that assessed the safety efficacy and pharmacokinetics (PK) of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH). Patients who meet the criteria for Study CORT118335-860 were randomized on Day 1 to receive 900 mg miricorilant, 600 mg miricorilant, or placebo for 12 weeks.
Due to observations related to safety, the study was terminated prior to completion and study objectives, endpoints, and procedures were modified as specified in the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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/m^2
- •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
Miricorilant- 900 mg
Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
干预措施: Miricorilant (Drug)
Miricorilant- 600 mg
Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
干预措施: Miricorilant (Drug)
Miricorilant- 600 mg
Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
干预措施: Placebo (Drug)
Placebo
Participants received 6 placebo tablets orally once daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Relative Change From Baseline in Liver Fat Content Assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction
时间窗: Baseline and up to ~Day 95
The change from baseline in liver fat content (LFC) by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) for each miricorilant dose level (600 mg, 900 mg) versus placebo was assessed. MRI-PDFF was performed to determine the degree of LFC reduction. The relative change is defined for each participant as %: (\[Post-Baseline LFC-Baseline LFC\]/Baseline LFC) × 100. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
次要结局
- Number of Participants Achieving a Relative Reduction From Baseline in LFC of ≥30% by MRI-PDFF(Baseline and up to ~Day 95)
- Change From Baseline in Aspartate Aminotransferase(Baseline and Week 6)
- Change From Baseline in Alanine Aminotransferase(Baseline and Week 6)
- Change From Baseline in Gamma-glutamyl Transferase(Baseline and Week 6)
- Change From Baseline in Propeptide of Type III Collagen(Baseline and Week 6)
- Change From Baseline in Enhanced Liver Fibrosis Score(Baseline and Week 6)