The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Intrahepatic Lipid Content (IHL, Percent Liver Fat)
研究概览
简要总结
Nonalcoholic fatty liver disease (NAFLD), fatty infiltration of the liver in the absence of alcohol use, is an increasingly recognized complication of obesity, with prevalence estimates of about 30% of individuals in the United States. A subset of these will develop progressive disease in the form of nonalcoholic steatohepatitis (NASH), which can progress to cirrhosis and liver failure. The investigators hypothesize that LUM-201 (Ibutamoren mesylate) will decrease intrahepatic lipid accumulation as quantified by proton magnetic resonance spectroscopy (1H-MRS).
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
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21-60yo and generally healthy
- •BMI ≥ 25 kg/m2
- •Radiographic or histologic diagnosis of NAFLD / NASH
- •Insulin-like growth factor-1 (IGF-1) level <3rd quartile of normal for age
排除标准
- •Contraindications to MRI imaging
- •Diabetes mellitus or use of diabetes medications
- •History of cancer, significant renal disease, decompensated or unstable cardiovascular disease
- •Cirrhosis or known liver disease other than NAFLD
- •Pregnancy or breastfeeding
- •Known pituitary or hypothalamic disease affecting the growth hormone axis
- •Chronic use of drugs causing hepatic steatosis in the past 12 months (chronic oral steroids, methotrexate, tamoxifen)
- •Treatment with medications that may interact with LUM-201 (ibutamoren mesylate)
研究组 & 干预措施
Open-label Treatment
Open-label study of oral LUM-201 (ibutamoren mesylate) 25mg daily in otherwise healthy adults with BMI ≥25 kg/m2 and histologic or radiologic diagnosis of NAFLD.
干预措施: LUM-201 (Drug)
结局指标
主要结局
Intrahepatic Lipid Content (IHL, Percent Liver Fat)
时间窗: 6 Months
Change in intrahepatic lipid content (6-month percent liver fat minus baseline percent liver fat) as measured by proton magnetic resonance spectroscopy (1H-MRS). Outcome is presented as change in percent liver fat.
次要结局
- Hepatic Inflammation and Fibrosis by LiverMultiScan Corrected T1 (cT1) Score(6 Months)
- Alanine Aminotransferase (ALT)(6 Months)
研究者
Laura Dichtel, MD
Principal Investigator
Massachusetts General Hospital