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Completed

NCT Number: NCT01588366

The Effects of LY2409021 on the Liver

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.

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Key information

Conditions

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

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Administered orally

LY2409021

Drug

Administered orally

Primary outcomes

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

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

    Measured by magnetic resonance (MR) scanning.

  2. Change From Baseline to Day 28 in Hepatic Glycogen Content

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

    Measured by MR scanning.

Secondary outcomes

  1. Change From Baseline to Day 28 in Transaminase Levels

    Time frame: Baseline, Day 28

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

    Time frame: Baseline, Day 29

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

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

    Time frame: Baseline, Day 29

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

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

    Time frame: Baseline, Day 29

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Effects of LY2409021 on Hepatic Metabolism in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 1, 2012
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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