Clinical trial NCT01588366: The Effects of LY2409021 on the Liver
Official title: Effects of LY2409021 on Hepatic Metabolism in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-05-01
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change From Baseline to Day 28 in Liver Fat Average Percent (%)
timeFrame: Baseline, Day 28 (Pre-meal)
measure: Change From Baseline to Day 28 in Hepatic Glycogen Content
timeFrame: Baseline, Day 28 (Pre-meal)
Secondary outcomes:
measure: Change From Baseline to Day 28 in Transaminase Levels
timeFrame: Baseline, Day 28
measure: Change From Baseline to Day 29 in Glucose Response to an Arginine Stimulation Test (AST) (Part A)
timeFrame: Baseline, Day 29
measure: Change From Baseline to Day 29 in Glucagon Response to an Arginine Stimulation Test (AST) (Part A)
timeFrame: Baseline, Day 29
measure: Change From Baseline to Day 29 in Insulin Response to an Arginine Stimulation Test (AST) (Part A)
timeFrame: Baseline, Day 29
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: