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The Effects of LY2409021 on the Liver

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

Singapore

Study Type

Interventional

Intervention

Placebo

LY2409021

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

15 mg LY2409021

60 mg LY2409021

Arm Description

Part A and B - Up to 4 capsules of placebo administered orally once a day for 28 days.

Part B - 1 capsule of 15 mg LY2409021 orally once a day for 28 days. (Arm added in September, 2012, per protocol amendment.)

Part A - 4 capsules of 15 mg LY2409021 administered orally once a day for 28 days.

Outcomes

Primary Outcome Measures

Change From Baseline to Day 28 in Liver Fat Average Percent (%)

Measured by magnetic resonance (MR) scanning.

Change From Baseline to Day 28 in Hepatic Glycogen Content

Measured by MR scanning.

Secondary Outcome Measures

Change From Baseline to Day 28 in Transaminase Levels

Change From Baseline to Day 29 in Glucose Response to an Arginine Stimulation Test (AST) (Part A)

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)

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)

Acute insulin response to an AST at a blood glucose level of approximately 250 mg/dL.

Full Information

NCT ID

NCT01588366

First Posted

April 27, 2012

Last Updated

November 16, 2018

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01588366

Brief Title

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

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Part A and B - Up to 4 capsules of placebo administered orally once a day for 28 days.

Arm Title

15 mg LY2409021

Arm Type

Experimental

Arm Description

Part B - 1 capsule of 15 mg LY2409021 orally once a day for 28 days. (Arm added in September, 2012, per protocol amendment.)

Arm Title

60 mg LY2409021

Arm Type

Experimental

Arm Description

Part A - 4 capsules of 15 mg LY2409021 administered orally once a day for 28 days.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

LY2409021

Intervention Description

Administered orally

Primary Outcome Measure Information:

Title

Change From Baseline to Day 28 in Liver Fat Average Percent (%)

Description

Measured by magnetic resonance (MR) scanning.

Time Frame

Baseline, Day 28 (Pre-meal)

Title

Change From Baseline to Day 28 in Hepatic Glycogen Content

Description

Measured by MR scanning.

Time Frame

Baseline, Day 28 (Pre-meal)

Secondary Outcome Measure Information:

Title

Change From Baseline to Day 28 in Transaminase Levels

Time Frame

Baseline, Day 28

Title

Change From Baseline to Day 29 in Glucose Response to an Arginine Stimulation Test (AST) (Part A)

Description

Acute glucose response to an AST at a blood glucose level of approximately 250 milligrams per deciliter (mg/dL).

Time Frame

Baseline, Day 29

Title

Change From Baseline to Day 29 in Glucagon Response to an Arginine Stimulation Test (AST) (Part A)

Description

Acute glucagon response to an AST at a blood glucose level of approximately 250 mg/dL.

Time Frame

Baseline, Day 29

Title

Change From Baseline to Day 29 in Insulin Response to an Arginine Stimulation Test (AST) (Part A)

Description

Acute insulin response to an AST at a blood glucose level of approximately 250 mg/dL.

Time Frame

Baseline, Day 29

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Singapore

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Effects of LY2409021 on the Liver

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