NCT06947304进行中（未招募）1 期
A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in fasting hepatic lipogenesis after 6 weeks of treatment
研究概览
简要总结
A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
详细描述
Approximately 8 patients who are eligible for participation in the study will be assigned to a single dose cohort receiving 100 mg of miricorilant daily. The total duration of participation for each patient is expected to be up to 16 weeks, comprising a 6-week screening period, a 6-week treatment phase, and a 4-week follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •AST > 17 U/L for women and AST > 20 U/L for men. The AST inclusion criterion does not apply to participants with an eligible historical liver biopsy performed within 12 months of screening showing one of the following:
- •NAFLD Activity Score (NAS) ≥ 4 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH Clinical Research Network (CRN) fibrosis score of F0 OR
- •NAS ≥ 3 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH CRN fibrosis score of F1 OR
- •NAS ≥ 2 (with at least 1 point in subcomponent of ballooning or inflammation) and a NASH CRN fibrosis score of F2-3
- •MRI-PDFF with ≥ 8% steatosis; this assessment must be performed within 4 weeks of the Baseline Visit.
- •Presence of at least 1 of the following metabolic syndrome characteristics that increase the risk of MASH:
- •a. Diagnosis of type 2 diabetes managed with diet alone or diet and metformin (metformin dose must be stable for at least 1 month prior to screening) OR b. Presence of 3 or more components of metabolic syndrome: i. Fasting blood glucose ≥ 100 mg/dL (5.6 mmol/L) or treatment for elevated blood glucose with metformin ii. Systolic blood pressure ≥ 130 mm Hg, diastolic blood pressure ≥ 85 mm Hg, or treatment for hypertension iii. Serum TG ≥ 150 mg/dL (1.7 mmol/L) iv. Serum high-density lipoprotein cholesterol (HDL) < 40 mg/dL (1 mmol/L) in men and < 50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL v. Having overweight or obesity (body mass index [BMI] ≥ 25 kg/m2 [BMI
- •23 kg/m2 in Asians]), or increased waist circumference ≥ 102 cm (40 in) in men and ≥ 88 cm (35 in) in women (men ≥ 90 cm [35.4 in]; women ≥ 80 cm [31.5 in] in Asians).
- •Other inclusion criteria may apply
排除标准
- •Participation in another clinical trial for MASH or weight loss (e.g., GLP-1 receptor agonists) within the last 3 months.
- •Participation in any other clinical trial within the last 3 months or 5 half-lives of the treatment, whichever is longer.
- •Women who are pregnant, planning to become pregnant, or lactating.
- •BMI < 18 kg/m² or > 45 kg/m².
- •Significant alcohol consumption exceeding 20 g/day for women or 30 g/day for men within 1 year prior to screening.
- •Positive urine drug screen for amphetamines, cocaine, opiates, or cannabinoids.
- •Known or suspected cirrhosis or signs of hepatic decompensation.
- •Other chronic liver diseases such as hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, or Wilson's disease.
- •History of myocardial infarction, unstable angina, or stroke within 3 months prior to screening.
- •Uncontrolled hypertension (systolic > 160 mm Hg or diastolic > 100 mm Hg).
- •Current use of medications prohibited due to potential drug-drug interactions with study treatment.
- •Contraindications to magnetic resonance imaging (MRI).
- •Other exclusion criteria may apply
研究组 & 干预措施
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.
干预措施: Miricorilant (Drug)
结局指标
主要结局
Change in fasting hepatic lipogenesis after 6 weeks of treatment
时间窗: Baseline to Week 6
Change in peak lipogenesis after 6 weeks of treatment.
时间窗: Baseline to Week 6
次要结局
- Change in liver fat content by MRI-PDFF after 6 weeks of treatment(Baseline to week 6)
研究者
研究点 (1)
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