The Effects of LY2409021 on the Liver

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588366
• Other study ID #: 13107
• Secondary ID: I1R-FW-GLBK
• Status: Completed
• Phase: Phase 1
• Start date: April 2012
• Est. completion date: September 2013

Study information

• Verified date: November 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo
Administered orally
• LY2409021
Administered orally

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Day 28 in Liver Fat Average Percent (%)	Measured by magnetic resonance (MR) scanning.	Baseline, Day 28 (Pre-meal)
Primary	Change From Baseline to Day 28 in Hepatic Glycogen Content	Measured by MR scanning.	Baseline, Day 28 (Pre-meal)
Secondary	Change From Baseline to Day 28 in Transaminase Levels		Baseline, Day 28
Secondary	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).	Baseline, Day 29
Secondary	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.	Baseline, Day 29
Secondary	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.	Baseline, Day 29