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| ID | Type | Description | Link |
|---|---|---|---|
| I6J-FW-PRBA | Other Identifier | Eli Lilly and Company |
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The aim of this trial is to evaluate the safety of the study drug in healthy participants and participants with diabetes. It will investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.
The study consists of two parts. Part A will study healthy participants in up to 3 dosing periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3 dosing periods over approximately 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (Part A) | Placebo Comparator | Single oral dose of placebo administered to healthy participants in up to 1 of 3 study periods in Part A |
|
| LY2922083 (Part A) | Experimental | Single ascending dose of LY2922083 (starting at 0.5 milligrams [mg]) administered orally to healthy participants in up to 2 of 3 study periods in Part A |
|
| Placebo (Part B) | Placebo Comparator | Single oral dose of placebo administered to participants with type 2 diabetes mellitus (T2DM) in up to 1 of 3 study periods in Part B |
|
| LY2922083 (Part B) | Experimental | Single ascending dose of LY2922083 administered orally to participants with T2DM in up to 2 of 3 study periods in Part B. Dose determined by Part A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Administered orally as capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 1 or More Serious Adverse Event(s) (SAEs) | Events deemed by the Investigator to be SAEs related to study drug administration are reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Baseline through study completion (up to 70 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Curve From Time 0 to Infinite Time [AUC(0-∞)] of LY2922083 | Predose up to 72 hours (h) after each dose of study drug (Part A: predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose. Part B: predose, 0.5, 1.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose.) | |
| PK: Maximum Concentration (Cmax) of LY2922083 |
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Inclusion Criteria:
For all participants :
For participants with T2DM:
Exclusion Criteria:
For all participants :
For participants with T2DM :
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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 | 117597 |
Single ascending dose crossover study with 2 parts and 3 periods per part. Part A had 3 cohorts (healthy participants). Part B had 1 cohort [with type 2 diabetes mellitus (T2DM)]. Participants in Part A, Cohort 3 completed 2 periods, as ninth (contingency) dose not tested based on interim data. There was ≥10 days between dosing for any participant.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A, Cohort 1, Sequence 1 | Healthy participants received a single oral dose of the following: Period 1: Placebo Period 2: 1.5 milligrams (mg) LY2922083 Period 3: 5 mg LY2922083 |
| FG001 | Part A, Cohort 1, Sequence 2 | Healthy participants received a single oral dose of the following: Period 1: 0.5 mg LY2922083 Period 2: Placebo Period 3: 5 mg LY2922083 |
| FG002 | Part A, Cohort 1, Sequence 3 | Healthy participants received a single oral dose of the following: Period 1: 0.5 mg LY2922083 Period 2: 1.5 mg LY2922083 Period 3: Placebo |
| FG003 | Part A, Cohort 2, Sequence 1 | Healthy participants received a single oral dose of the following: Period 1: Placebo Period 2: 50 mg LY2922083 Period 3: 150 mg LY2922083 |
| FG004 | Part A, Cohort 2, Sequence 2 | Healthy participants received a single oral dose of the following: Period 1: 15 mg LY2922083 Period 2: Placebo Period 3: 150 mg LY2922083 |
| FG005 | Part A, Cohort 2, Sequence 3 | Healthy participants received a single oral dose of the following: Period 1: 15 mg LY2922083 Period 2: 50 mg LY2922083 Period 3: Placebo |
| FG006 | Part A, Cohort 3, Sequence 1 | Healthy participants received a single oral dose of the following: Period 1: Placebo Period 2: 845 mg LY2922083 |
| FG007 | Part A, Cohort 3, Sequence 2 | Healthy participants received a single oral dose of the following: Period 1: 450 mg LY2922083 Period 2: Placebo |
| FG008 | Part A, Cohort 3, Sequence 3 | Healthy participants received a single oral dose of the following: Period 1: 450 mg LY2922083 Period 2: 845 mg LY2922083 |
| FG009 | Part B, Cohort 1, Sequence 1 | Participants with T2DM received a single oral dose of the following: Period 1: Placebo Period 2: 450 mg LY2922083 Period 3: 845 mg LY2922083 |
| FG010 | Part B, Cohort 1, Sequence 2 | Participants with T2DM received a single oral dose of the following: Period 1: 150 mg LY2922083 Period 2: Placebo Period 3: 845 mg LY2922083 |
| FG011 | Part B, Cohort 1, Sequence 3 | Participants with T2DM received a single oral dose of the following: Period 1: 150 mg LY2922083 Period 2: 450 mg LY2922083 Period 3: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Period 1 and Washout |
| |||||||||||||
| Intervention Period 2 and Washout |
| |||||||||||||
| Intervention Period 3 and Washout |
|
Safety population: all participants who received at least 1 dose of study drug or placebo, and had at least 1 postdose safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A, Cohort 1, Sequence 1 | Healthy participants received a single oral dose of the following: Period 1: Placebo Period 2: 1.5 milligrams (mg) LY2922083 Period 3: 5 mg LY2922083 |
| BG001 | Part A, Cohort 1, Sequence 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With 1 or More Serious Adverse Event(s) (SAEs) | Events deemed by the Investigator to be SAEs related to study drug administration are reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Safety population: all participants who received at least 1 dose of study drug or placebo, and had at least 1 postdose safety assessment. | Posted | Count of Participants | Participants | No | Baseline through study completion (up to 70 days) |
|
Baseline through study completion (up to 70 days)
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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 (Parts A and B) | Healthy participants or participants with T2DM, in Part A or B, Cohorts 1, 2, or 3, who received a single oral dose of placebo in 1 of 3 study periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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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 |
|---|---|
| C000620332 | LY2922083 |
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| LY2922083 |
| Drug |
Administered orally as capsules |
|
| Predose up to 72 h after each dose of study drug (Part A: predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose. Part B: predose, 0.5, 1.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose.) |
| Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time 0 to 24 h Postdose [AUEC(0-24)] | Least Squares (LS) mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error. | Baseline (predose for Part A and Day -1 time-matched for Part B), up to 24 h postdose (1.5, 2.5, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18, and 24 h postdose) |
| Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time 0 to 6 h Postdose [AUEC(0-6)] | LS mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error. | Baseline (predose for Part A and Day -1 time-matched for Part B), up to 6 h postdose (1.5, 2.5, 4, 4.5, 5, and 6 h postdose) |
| Singapore |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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Healthy participants received a single oral dose of the following:
Period 1: 0.5 mg LY2922083 Period 2: Placebo Period 3: 5 mg LY2922083
| BG002 | Part A, Cohort 1, Sequence 3 | Healthy participants received a single oral dose of the following: Period 1: 0.5 mg LY2922083 Period 2: 1.5 mg LY2922083 Period 3: Placebo |
| BG003 | Part A, Cohort 2, Sequence 1 | Healthy participants received a single oral dose of the following: Period 1: Placebo Period 2: 50 mg LY2922083 Period 3: 150 mg LY2922083 |
| BG004 | Part A, Cohort 2, Sequence 2 | Healthy participants received a single oral dose of the following: Period 1: 15 mg LY2922083 Period 2: Placebo Period 3: 150 mg LY2922083 |
| BG005 | Part A, Cohort 2, Sequence 3 | Healthy participants received a single oral dose of the following: Period 1: 15 mg LY2922083 Period 2: 50 mg LY2922083 Period 3: Placebo |
| BG006 | Part A, Cohort 3, Sequence 1 | Healthy participants received a single oral dose of the following: Period 1: Placebo Period 2: 845 mg LY2922083 |
| BG007 | Part A, Cohort 3, Sequence 2 | Healthy participants received a single oral dose of the following: Period 1: 450 mg LY2922083 Period 2: Placebo |
| BG008 | Part A, Cohort 3, Sequence 3 | Healthy participants received a single oral dose of the following: Period 1: 450 mg LY2922083 Period 2: 845 mg LY2922083 |
| BG009 | Part B, Cohort 1, Sequence 1 | Participants with T2DM received a single oral dose of the following: Period 1: Placebo Period 2: 450 mg LY2922083 Period 3: 845 mg LY2922083 |
| BG010 | Part B, Cohort 1, Sequence 2 | Participants with T2DM received a single oral dose of the following: Period 1: 150 mg LY2922083 Period 2: Placebo Period 3: 845 mg LY2922083 |
| BG011 | Part B, Cohort 1, Sequence 3 | Participants with T2DM received a single oral dose of the following: Period 1: 150 mg LY2922083 Period 2: 450 mg LY2922083 Period 3: Placebo |
| BG012 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
Healthy participants in Part A, Cohort 1 who received a single oral dose of 0.5 mg LY2922083 in study period 1. |
| OG002 | 1.5 mg LY2922083 (Part A) | Healthy participants in Part A, Cohort 1 who received a single oral dose of 1.5 mg LY2922083 in study period 2. |
| OG003 | 5 mg LY2922083 (Part A) | Healthy participants in Part A, Cohort 1 who received a single oral dose of 5 mg LY2922083 in study period 3. |
| OG004 | 15 mg LY2922083 (Part A) | Healthy participants in Part A, Cohort 2 who received a single oral dose of 15 mg LY2922083 in study period 1. |
| OG005 | 50 mg LY2922083 (Part A) | Healthy participants in Part A, Cohort 2 who received a single oral dose of 50 mg LY2922083 in study period 2. |
| OG006 | 150 mg LY2922083 (Parts A and B) | Healthy participants in Part A, Cohort 2 who received a single oral dose of 150 mg LY2922083 in study period 3 and participants with T2DM in Part B, Cohort 1 who received a single oral dose of 150 mg LY2922083 in study period 1. |
| OG007 | 450 mg LY2922083 (Parts A and B) | Healthy participants in Part A, Cohort 3 who received a single oral dose of 450 mg LY2922083 in study period 1 and participants with T2DM in Part B, Cohort 1 who received a single oral dose of 450 mg LY2922083 in study period 2. |
| OG008 | 845 mg LY2922083 (Parts A and B) | Healthy participants in Part A, Cohort 3 who received a single oral dose of 845 mg LY2922083 in study period 2 and participants with T2DM in Part B, Cohort 1 who received a single oral dose of 845 mg LY2922083 in study period 3. |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Curve From Time 0 to Infinite Time [AUC(0-∞)] of LY2922083 | All participants who received at least 1 dose of the study drug and had sufficient PK data to calculate AUC(0-∞). | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter (ng*hr/mL) | Predose up to 72 hours (h) after each dose of study drug (Part A: predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose. Part B: predose, 0.5, 1.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose.) |
|
|
|
| Secondary | PK: Maximum Concentration (Cmax) of LY2922083 | All participants who received at least 1 dose of the study drug and had sufficient PK data to calculate Cmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Predose up to 72 h after each dose of study drug (Part A: predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose. Part B: predose, 0.5, 1.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose.) |
|
|
|
| Secondary | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time 0 to 24 h Postdose [AUEC(0-24)] | Least Squares (LS) mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error. | All participants who received at least 1 dose of the study drug or placebo and had sufficient pharmacodynamic data to calculate glucose AUEC(0-24). | Posted | Least Squares Mean | Standard Error | millimoles*hour per liter (mmol*h/L) | Baseline (predose for Part A and Day -1 time-matched for Part B), up to 24 h postdose (1.5, 2.5, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18, and 24 h postdose) |
|
|
|
| Secondary | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time 0 to 6 h Postdose [AUEC(0-6)] | LS mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error. | All participants who received at least 1 dose of the study drug or placebo and had sufficient pharmacodynamic data to calculate C-peptide AUEC(0-6). | Posted | Least Squares Mean | Standard Error | picomoles*hour per liter (pmol*h/L) | Baseline (predose for Part A and Day -1 time-matched for Part B), up to 6 h postdose (1.5, 2.5, 4, 4.5, 5, and 6 h postdose) |
|
|
|
| 0 |
| 32 |
| 12 |
| 32 |
| EG001 | 0.5 mg LY2922083 (Part A) | Healthy participants in Part A, Cohort 1 who received a single oral dose of 0.5 mg LY2922083 in study period 1. | 0 | 6 | 1 | 6 |
| EG002 | 1.5 mg LY2922083 (Part A) | Healthy participants in Part A, Cohort 1 who received a single oral dose of 1.5 mg LY2922083 in study period 2. | 0 | 6 | 2 | 6 |
| EG003 | 5 mg LY2922083 (Part A) | Healthy participants in Part A, Cohort 1 who received a single oral dose of 5 mg LY2922083 in study period 3. | 0 | 6 | 0 | 6 |
| EG004 | 15 mg LY2922083 (Part A) | Healthy participants in Part A, Cohort 2 who received a single oral dose of 15 mg LY2922083 in study period 1. | 0 | 6 | 2 | 6 |
| EG005 | 50 mg LY2922083 (Part A) | Healthy participants in Part A, Cohort 2 who received a single oral dose of 50 mg LY2922083 in study period 2. | 0 | 6 | 5 | 6 |
| EG006 | 150 mg LY2922083 (Parts A and B) | Healthy participants in Part A, Cohort 2 who received a single oral dose of 150 mg LY2922083 in study period 3 and participants with T2DM in Part B, Cohort 1 who received a single oral dose of 150 mg LY2922083 in study period 1. | 0 | 12 | 9 | 12 |
| EG007 | 450 mg LY2922083 (Parts A and B) | Healthy participants in Part A, Cohort 3 who received a single oral dose of 450 mg LY2922083 in study period 1 and participants with T2DM in Part B, Cohort 1 who received a single oral dose of 450 mg LY2922083 in study period 2. | 0 | 12 | 8 | 12 |
| EG008 | 845 mg LY2922083 (Parts A and B) | Healthy participants in Part A, Cohort 3 who received a single oral dose of 845 mg LY2922083 in study period 2 and participants with T2DM in Part B, Cohort 1 who received a single oral dose of 845 mg LY2922083 in study period 3. | 0 | 12 | 6 | 12 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Catheter site erythema | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Catheter site haematoma | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |