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| ID | Type | Description | Link |
|---|---|---|---|
| I1R-FW-GLBK | Other Identifier | Eli Lilly and Company |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Part A and B - Up to 4 capsules of placebo administered orally once a day for 28 days. |
|
| 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.) |
|
| 60 mg LY2409021 | Experimental | Part A - 4 capsules of 15 mg LY2409021 administered orally once a day for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Administered orally |
| |
| LY2409021 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Acute glucose response to an AST at a blood glucose level of approximately 250 milligrams per deciliter (mg/dL). |
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Inclusion Criteria:
For all participants:
For participants with type 2 diabetes mellitus (T2DM):
- On diet and exercise treatment, or taking metformin
Exclusion Criteria:
For all participants:
For participants with T2DM:
- Are using insulin
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
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Study started in April, 2012 with Part A. Part B was added per protocol amendment in September, 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo - Healthy (Part A) | Placebo administered orally, once daily (QD) for 28 days to healthy participants. |
| FG001 | 60 mg LY2409021 - Healthy (Part A) | 60 milligrams (mg) LY2409021 administered orally, QD for 28 days to healthy participants. |
| FG002 | Placebo - T2DM (Part A) | Placebo administered orally, QD for 28 days to participants with type 2 diabetes mellitus (T2DM). |
| FG003 | 60 mg LY2409021 - T2DM (Part A) | 60 mg LY2409021 administered orally, QD for 28 days to participants with T2DM. |
| FG004 | Placebo - T2DM (Part B) | Placebo administered orally, QD for 28 days to participants with T2DM. |
| FG005 | 15 mg LY2409021 - T2DM (Part B) | 15 mg LY2409021 administered orally, QD for 28 days to participants with T2DM. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo - Healthy (Part A) | Placebo administered orally, QD for 28 days to healthy participants. |
| BG001 | 60 mg LY2409021 - Healthy (Part A) | 60 mg LY2409021 administered orally, QD for 28 days to healthy participants. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Day 28 in Liver Fat Average Percent (%) | Measured by magnetic resonance (MR) scanning. | All participants who had evaluable MR scans at Baseline and on Day 28. | Posted | Mean | 95% Confidence Interval | percentage of liver fat average | Baseline, Day 28 (Pre-meal) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo - Healthy (Part A) | Placebo administered orally, QD for 28 days to healthy participants. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000601762 | adomeglivant |
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| Drug |
Administered orally |
|
| Baseline, Day 29 |
| 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 |
| 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 |
| Singapore |
| BG002 | Placebo - T2DM (Parts A and B) | Placebo administered orally, QD for 28 days to participants with T2DM. |
| BG003 | 15 mg LY2409021 - T2DM (Part B) | 15 mg LY2409021 administered orally, QD for 28 days to participants with T2DM. |
| BG004 | 60 mg LY2409021 - T2DM (Part A) | 60 mg LY2409021 administered orally, QD for 28 days to participants with T2DM. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Placebo - T2DM (Parts A and B) |
Placebo administered orally, QD for 28 days to participants with T2DM. |
| OG003 | 15 mg LY2409021 - T2DM (Part B) | 15 mg LY2409021 administered orally, QD for 28 days to participants with T2DM. |
| OG004 | 60 mg LY2409021 - T2DM (Part A) | 60 mg LY2409021 administered orally, QD for 28 days to participants with T2DM. |
|
|
| Primary | Change From Baseline to Day 28 in Hepatic Glycogen Content | Measured by MR scanning. | All participants in Part A who received 60 mg LY2409021 and had evaluable MR scans at Baseline and on Day 28. | Posted | Mean | 95% Confidence Interval | millimoles per liter (mmol/L) | Baseline, Day 28 (Pre-meal) |
|
|
|
| Secondary | Change From Baseline to Day 28 in Transaminase Levels | All participants who had evaluable transaminase levels at Baseline and on Day 28. | Posted | Mean | Standard Deviation | units per liter (U/L) | 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). | Zero participants were analyzed for this outcome measure because glucose response data was not collected or included in the data analysis plan. | Posted | 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. | All participants in Part A who received 60 mg LY2409021 and had an evaluable glucagon response at Baseline and on Day 29. | Posted | Mean | 95% Confidence Interval | pmol/L | 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. | All participants in Part A who received 60 mg LY2409021 and had an evaluable insulin response at Baseline and on Day 29. | Posted | Mean | 95% Confidence Interval | pmol/L | Baseline, Day 29 |
|
|
|
| 0 |
| 2 |
| 1 |
| 2 |
| EG001 | 60 mg LY2409021 - Healthy (Part A) | 60 mg LY2409021 administered orally, QD for 28 days to healthy participants. | 0 | 7 | 7 | 7 |
| EG002 | Placebo - T2DM (Parts A and B) | Placebo administered orally, QD for 28 days to participants with T2DM. | 0 | 5 | 4 | 5 |
| EG003 | 15 mg LY2409021 - T2DM (Part B) | 15 mg LY2409021 administered orally, QD for 28 days to participants with T2DM. | 2 | 9 | 7 | 9 |
| EG004 | 60 mg LY2409021 - T2DM (Part A) | 60 mg LY2409021 administered orally, QD for 28 days to participants with T2DM. | 0 | 7 | 4 | 7 |
| Presyncope | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Catheter site erythema | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Catheter site haematoma | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Scratch | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| Aspartate aminotransferase (AST) |
|