NCT04073407终止不适用
A Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Physiological Effects on Liver Structure and Function of an Amino Acid Food Product, AXA1957, in Adolescent Subjects With Fatty Liver
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 6
- 主要终点
- Number of Subjects With Adverse Events (AEs).
研究概览
简要总结
This is a randomized, single blind study to determine whether AXA1957, a novel composition of amino acids, is safe and well tolerated. Subjects will be adolescents with non-alcoholic fatty liver disease (NAFLD), and it will also examine liver biology using blood tests and magnetic resonance imaging (MRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to participate in the study and provide written informed consent.
- •Male and female adolescent subjects aged 12 to 17 years
- •Subjects must not have participated in any diet/lifestyle intervention or observational studies, or engaged in any body weight altering regimens that resulted in body weight fluctuations (i.e. body weight loss or gain by 5%) in the preceding 30 days prior to Screening.
- •Non alcoholic fatty liver disease
- •Diabetes or prediabetes
- •A screening MRI consistent with liver inflammation and fibrosis
排除标准
- •Current or history of significant alcohol consumption
- •History or presence of liver disease (other than NAFLD/NASH)
- •History or presence of cirrhosis and/or history or presence of hepatic decompensation
- •Any diabetes other than Type 2
- •Other poorly controlled medical condition (for example, uncontrolled hypertension with a systolic blood pressure > 100 mmHg)
- •Known sensitivity and/or history of clinically significant food intolerance/allergies to proteins (including whey, soy, casein, amino acids, etc.),
- •Unable or unwilling to adhere to contraception requirements
- •Any contraindications to a MRI scan
- •Any other condition that, in the opinion of the Investigator, renders the subject at risk for compliance, compromises the well-being of the subject, or hinders study completion
结局指标
主要结局
Number of Subjects With Adverse Events (AEs).
时间窗: AEs Baseline to week 13 - Part 1
Study food product emergent adverse events (AEs). Subjects reporting \>or equal to 1 study food product-emergent AE.
次要结局
未报告次要终点
研究者
研究点 (6)
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