The Effects of LY2409021 on the Liver

NCT01588366 | Completed Phase 1 Results

• 2 other identifiers: 13107I1R-FW-GLBK
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

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

  Measured by magnetic resonance (MR) scanning.

  Baseline, Day 28 (Pre-meal)

• Change From Baseline to Day 28 in Hepatic Glycogen Content

  Measured by MR scanning.

  Baseline, Day 28 (Pre-meal)

Secondary Outcomes (4)

• Change From Baseline to Day 28 in Transaminase Levels

  Baseline, Day 28

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

  Baseline, Day 29

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

  Baseline, Day 29

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

  Baseline, Day 29

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

15 mg LY2409021

EXPERIMENTAL

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

Drug: LY2409021

60 mg LY2409021

EXPERIMENTAL

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

Drug: LY2409021

Interventions

Placebo DRUG

Administered orally

Placebo

LY2409021 DRUG

Administered orally

15 mg LY2409021; 60 mg LY2409021

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

adomeglivant

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 1, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 7, 2019
• Results First Posted: March 7, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)