NCT07553663招募中1 期
A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Assessment of miricorilant PK parameters
研究概览
简要总结
A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
详细描述
Approximately 15 patients who are eligible for participation in the study will be administered a single dose of 60 mg of miricorilant. The maximum expected duration of a patient's participation is 56 days (up to 28 days of screening, followed by single-dose administration and 4 days of observation, and then 24 days of follow-up).
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
- •Evidence of presumed MASH with either FibroScan liver stiffness measurement ≥ 8 kPa and controlled attenuation parameter (CAP) ≥ 280 dB/m OR historical biopsy within 12 months of screening that meets the following criteria:
- •Nonalcoholic fatty liver disease (NAFLD) activity score (NAS) ≥ 3 with at least ≥ 1 point in any two subcomponents of steatosis, inflammation, and ballooning, and a Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) fibrosis score of F1 OR
- •NAS ≥ 2 with at least ≥ 1 point in any two subcomponents of steatosis, inflammation, and ballooning, and a NASH CRN fibrosis score of F2 or
- •Aspartate aminotransferase (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.
- •Presence of at least 1 of the following metabolic conditions that increase the risk of MASH:
- •Diagnosis of type 2 diabetes OR
- •Presence of 2 or more components of metabolic syndrome:
- •Fasting blood glucose ≥ 100 mg/dL (5.6 mmol/L) or treatment for elevated blood glucose
- •Systolic blood pressure ≥ 130 mm Hg, diastolic blood pressure ≥ 85 mm Hg, or treatment for hypertension
- •Serum triglycerides ≥ 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides
- •Serum high-density lipoprotein (HDL) cholesterol < 40 mg/dL (1 mmol/L) in men and < 50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL
- •Overweight or obese (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).
排除标准
- •Women who are pregnant, planning to become pregnant, or are lactating.
- •Have a BMI < 18 kg/m2 or > 45 kg/m
- •Have significant alcohol consumption of more than 20 g per day for women and 30 g per day for men within 1 year prior to screening or score of ≥8 on AUDIT questionnaire
- •Have had liver transplantation or plan to have liver transplantation during the study.
- •Have type 1 diabetes.
- •Have poorly controlled type 2 diabetes with a glycated hemoglobin (HbA1c)
- •Have any other chronic liver disease
- •History of cirrhosis or evidence of cirrhosis by clinical, imaging, or liver biopsy evaluation
- •Have hepatic decompensation
- •Other exclusion criteria may apply
研究组 & 干预措施
Miricorilant 60mg
Experimental
Patients who meet the entry criteria for study CORT118335-863 will be administered a single dose of 60 mg miricorilant.
干预措施: Miricorilant (Drug)
结局指标
主要结局
Assessment of miricorilant PK parameters
时间窗: Day 1- Day 4
Time to maximum concentration (Tmax)
Assessment of miricorilant PK parameters
时间窗: Day 1 - Day 4
Maximum concentration over the dosing interval (Cmax)
次要结局
- Incidence of adverse events (AEs), serious adverse events (SAEs), clinical laboratory evaluations, (hematology, clinical chemistry, urinalysis), 12-lead electrocardiograms (ECGs), vital sign measurements and physical examinations.(Day 1- Day 28)
研究者
研究点 (1)
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