The Effects of LY2409021 on the Liver
- Registration Number
- NCT01588366
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 60 mg LY2409021 LY2409021 Part A - 4 capsules of 15 mg LY2409021 administered orally once a day for 28 days. Placebo Placebo Part A and B - Up to 4 capsules of placebo administered orally once a day for 28 days. 15 mg LY2409021 LY2409021 Part B - 1 capsule of 15 mg LY2409021 orally once a day for 28 days. (Arm added in September, 2012, per protocol amendment.)
- Primary Outcome Measures
Name Time Method Change From Baseline to Day 28 in Liver Fat Average Percent (%) Baseline, Day 28 (Pre-meal) Measured by magnetic resonance (MR) scanning.
Change From Baseline to Day 28 in Hepatic Glycogen Content Baseline, Day 28 (Pre-meal) Measured by MR scanning.
- Secondary Outcome Measures
Name Time Method 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 Acute glucose response to an AST at a blood glucose level of approximately 250 milligrams per deciliter (mg/dL).
Change From Baseline to Day 29 in Glucagon Response to an Arginine Stimulation Test (AST) (Part A) Baseline, Day 29 Acute glucagon response to an AST at a blood glucose level of approximately 250 mg/dL.
Change From Baseline to Day 29 in Insulin Response to an Arginine Stimulation Test (AST) (Part A) Baseline, Day 29 Acute insulin response to an AST at a blood glucose level of approximately 250 mg/dL.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
🇸🇬Singapore, Singapore