The Effects of LY2409021 on the Liver

Eli Lilly and Company30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

PlaceboDRUG

Administered orally

LY2409021DRUG

Administered orally

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Outcomes

Primary Outcomes

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

Measured by magnetic resonance (MR) scanning.

Time frame: Baseline, Day 28 (Pre-meal)

Change From Baseline to Day 28 in Hepatic Glycogen Content

Measured by MR scanning.

Time frame: Baseline, Day 28 (Pre-meal)

Secondary Outcomes

Change From Baseline to Day 28 in Transaminase Levels

Time frame: Baseline, Day 28

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).

Time frame: Baseline, Day 29

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.

Time frame: Baseline, Day 29

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.

Time frame: Baseline, Day 29

Data from ClinicalTrials.gov

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