The Effects of LY2409021 on the Liver - Full Text View

Purpose

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	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Placebo Drug: LY2409021	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science
Official Title:	Effects of LY2409021 on Hepatic Metabolism in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Type 2

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Change from Baseline to Day 28 in hepatic lipid content [ Time Frame: Baseline, Day 28 ] [ Designated as safety issue: No ]
Change from Baseline to Day 28 in hepatic glycogen content [ Time Frame: Baseline, Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from Baseline to Day 28 in transaminase levels [ Time Frame: Baseline, Day 28 ] [ Designated as safety issue: Yes ]
Glucose response to an Arginine Stimulation Test (Part A) [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: No ]
Glucagon response to an Arginine Stimulation Test (Part A) [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: No ]
Insulin response to an Arginine Stimulation Test (Part A) [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: No ]


Estimated Enrollment:	36
Study Start Date:	April 2012
Study Completion Date:	September 2013
Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	21 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588366

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


Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01588366 History of Changes
Other Study ID Numbers:	13107 I1R-FW-GLBK
Study First Received:	April 27, 2012
Last Updated:	September 10, 2013
Health Authority:	Singapore: Health Sciences Authority

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 30, 2016