Effects of LY2409021 on Hepatic Metabolism in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change From Baseline to Day 28 in Liver Fat Average Percent (%)
研究概览
简要总结
This is a study that involves multiple doses of study drug (60 mg of LY2409021, 15 mg of LY2409021 or placebo) taken as capsules by mouth on a daily basis for 28 days. This study will image the liver using magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) in healthy participants and in participants with type 2 diabetes mellitus, when they take LY2409021 to see if liver changes happen at the same time as changes in blood tests. This study is approximately 11 weeks long, not including screening. A screening appointment is required within 28 days prior to the start of the study.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For all participants:
- •Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes
- •Must have a body mass index (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m^2) if a healthy participant, or a BMI of 18.5 to 35.0 kg/m^2 if diabetic
- •For participants with type 2 diabetes mellitus (T2DM):
- •On diet and exercise treatment, or taking metformin
排除标准
- •For all participants:
- •Have signs or symptoms of liver disease
- •Are infected with hepatitis B or hepatitis C
- •Have donated more than 450 mL of blood in the last 3 months or if have donated any blood in the last month
- •Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
- •Have had surgery with metallic clips, staples or stents, or have had a cardiac pacemaker (or other surgical implants) inserted in any part of the body, or have fear of enclosed spaces or have symptoms that prevent them from being sent for an magnetic resonance imaging (MRI) scan
- •For participants with T2DM:
- •Are using insulin
研究组 & 干预措施
Placebo
Part A and B - Up to 4 capsules of placebo administered orally once a day for 28 days.
干预措施: Placebo (Drug)
15 mg LY2409021
Part B - 1 capsule of 15 mg LY2409021 orally once a day for 28 days. (Arm added in September, 2012, per protocol amendment.)
干预措施: LY2409021 (Drug)
60 mg LY2409021
Part A - 4 capsules of 15 mg LY2409021 administered orally once a day for 28 days.
干预措施: LY2409021 (Drug)
结局指标
主要结局
Change From Baseline to Day 28 in Liver Fat Average Percent (%)
时间窗: Baseline, Day 28 (Pre-meal)
Measured by magnetic resonance (MR) scanning.
Change From Baseline to Day 28 in Hepatic Glycogen Content
时间窗: Baseline, Day 28 (Pre-meal)
Measured by MR scanning.
次要结局
- Change From Baseline to Day 28 in Transaminase Levels(Baseline, Day 28)
- Change From Baseline to Day 29 in Glucose Response to an Arginine Stimulation Test (AST) (Part A)(Baseline, Day 29)
- Change From Baseline to Day 29 in Glucagon Response to an Arginine Stimulation Test (AST) (Part A)(Baseline, Day 29)
- Change From Baseline to Day 29 in Insulin Response to an Arginine Stimulation Test (AST) (Part A)(Baseline, Day 29)