The Effects of LY2409021 on the Liver

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Drug: Placebo; Drug: LY2409021	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	36 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Basic Science
Official Title:	Effects of LY2409021 on Hepatic Metabolism in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus
Study Start Date :	April 2012
Actual Primary Completion Date :	September 2013
Actual Study Completion Date :	September 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Placebo Comparator: Placebo; Part A and B - Up to 4 capsules of placebo administered orally once a day for 28 days.	Drug: Placebo; Administered orally
Experimental: 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.)	Drug: LY2409021; Administered orally
Experimental: 60 mg LY2409021; Part A - 4 capsules of 15 mg LY2409021 administered orally once a day for 28 days.	Drug: LY2409021; Administered orally

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Change from Baseline to Day 28 in hepatic lipid content [ Time Frame: Baseline, Day 28 ]
2. Change from Baseline to Day 28 in hepatic glycogen content [ Time Frame: Baseline, Day 28 ]

Secondary Outcome Measures :

1. Change from Baseline to Day 28 in transaminase levels [ Time Frame: Baseline, Day 28 ]
2. Glucose response to an Arginine Stimulation Test (Part A) [ Time Frame: Baseline and Day 29 ]
3. Glucagon response to an Arginine Stimulation Test (Part A) [ Time Frame: Baseline and Day 29 ]
4. Insulin response to an Arginine Stimulation Test (Part A) [ Time Frame: Baseline and Day 29 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	21 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Singapore
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

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:	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)	Eli Lilly and Company

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01588366 History of Changes
Other Study ID Numbers:	13107; I1R-FW-GLBK ( Other Identifier: Eli Lilly and Company )
First Posted:	May 1, 2012
Last Update Posted:	September 11, 2013
Last Verified:	September 2013

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases