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The Effects of LY2409021 on the Liver

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ClinicalTrials.gov Identifier: NCT01588366
Recruitment Status : Completed
First Posted : May 1, 2012
Last Update Posted : September 11, 2013
Sponsor:
Information provided by (Responsible Party):
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.

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

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

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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    Key Record Dates
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