The Effects of LY2409021 on the Liver

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: LY2409021; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01588366

13107

I1R-FW-GLBK (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

15 mg LY2409021

Experimental group

Description:

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

Treatment:

Drug: LY2409021

60 mg LY2409021

Experimental group

Description:

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

Treatment:

Drug: LY2409021