Phase 1
Completed N=30
The Effects of LY2409021 on the Liver
Source: ClinicalTrials.gov NCT01588366 ↗Enrolled (actual)
30
Serious AEs
6.7%
Results posted
Mar 2019
Primary outcomePrimary: Change From Baseline to Day 28 in Liver Fat Average Percent (%) — -0.47; 5.55; -1.49; 4.45 percentage of liver fat average
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Day 28 in Liver Fat Average Percent (%) |
-0.47; 5.55; -1.49; 4.45; 5.84 | — |
| PRIMARY Change From Baseline to Day 28 in Hepatic Glycogen Content |
12.8; 42.1 | — |
| SECONDARY Change From Baseline to Day 28 in Transaminase Levels |
-0.5; 47.7; -3.5; 15.7; 13.3; 0.3 | — |
| SECONDARY Change From Baseline to Day 29 in Glucose Response to an Arginine Stimulation Test (AST) (Part A) |
— | — |
| SECONDARY Change From Baseline to Day 29 in Glucagon Response to an Arginine Stimulation Test (AST) (Part A) |
80.0; 103 | — |
| SECONDARY Change From Baseline to Day 29 in Insulin Response to an Arginine Stimulation Test (AST) (Part A) |
-34.7; 139 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01588366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.