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| ID | Type | Description | Link |
|---|---|---|---|
| I5O-FW-GTCA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to determine the safety of LY3009385 in healthy participants. The study drug is given as a single dose, by injections under the skin. Side effects will be documented. This study is approximately 28 days not including screening. Screening is required within 28 days prior to the start of the study.
This is a single ascending dose study that examines the safety and tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single doses of LY3009385 administered subcutaneously to healthy participants. The planned dose levels are 0.3, 1, 3, 9, 27, and 54 milligrams (mg). Within each dose level, participants are randomized to receive either LY3009385 or Placebo.
Adjustments to the dose levels were permitted after review of emerging safety, PK, and glycemic data.
The actual LY3009385 dose levels tested during this study were 0.3, 1, 3, 9, 22, and 54 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.3 mg LY3009385 | Experimental | LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
|
| 1 mg LY3009385 | Experimental | LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
|
| 3 mg LY3009385 | Experimental | LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
|
| 9 mg LY3009385 | Experimental | LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
|
| 22 mg LY3009385 | Experimental | LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
|
| 54 mg LY3009385 | Experimental | LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3009385 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs | The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Baseline through Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385 | LY3009385 exposure in terms of AUC from time 0 extrapolated to infinity (AUC[0-inf]) is summarized. | Predose through Day 28 |
| Pharmacokinetics: Maximum Concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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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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| ID | Title | Description |
|---|---|---|
| FG000 | 0.3 mg LY3009385 | LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| FG001 | 1 mg LY3009385 | LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| FG002 | 3 mg LY3009385 | LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| FG003 | 9 mg LY3009385 | LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| FG004 | 22 mg LY3009385 | LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| FG005 | 54 mg LY3009385 | LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| FG006 | Placebo | Placebo: saline, subcutaneous (SC) injection, single dose on Day 1 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.3 mg LY3009385 | LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| BG001 | 1 mg LY3009385 | LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| 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 | Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs | The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | All enrolled participants. | Number | participants | Baseline through Day 28 |
|
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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 | 0.3 mg LY3009385 | LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
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| 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 |
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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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|
| Placebo | Placebo Comparator | Placebo: saline, subcutaneous (SC) injection, single dose on Day 1 |
|
| Placebo | Drug |
|
The maximum observed plasma concentration (Cmax) of LY3009385 is summarized.
| Predose through Day 28 |
| Change in Level of Blood Glucose Before and After a Standard Meal | The effect of LY3009385 on postprandial blood glucose was evaluated. Change from baseline area under the glucose concentration-time curve from time 0 to 6 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm. | Baseline, Day 5, and Day 14 |
| Change in Level of C-peptide Before and After a Standard Meal | The effect of LY3009385 on postprandial c-peptide was assessed. Change from baseline area under the c-peptide concentration-time curve from time 0 to 4 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm. | Baseline, Day 5, and Day 14 |
| Change in Level of Glucagon Before and After a Standard Meal | The effect of LY3009385 on postprandial glucagon levels was assessed. Change from baseline glucagon concentrations 2 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) were calculated and summarized by treatment arm. | Baseline, Day 14 |
| Number of Participants Forming Antibody to LY3009385 | The number of participants with postbaseline detection of LY3009385treatment-emergent (TE) antidrug antibodies (ADA), defined as a 4-fold increase in the ADA titer from baseline. | Baseline through Day 28 |
| Singapore |
| BG002 | 3 mg LY3009385 | LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| BG003 | 9 mg LY3009385 | LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| BG004 | 22 mg LY3009385 | LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| BG005 | 54 mg LY3009385 | LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| BG006 | Placebo | Placebo: saline, subcutaneous (SC) injection, single dose on Day 1 |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fasting Blood Glucose | Mean | Standard Deviation | milligrams per deciliter (mg/dL) |
|
| OG001 | 1 mg LY3009385 | LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| OG002 | 3 mg LY3009385 | LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| OG003 | 9 mg LY3009385 | LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| OG004 | 22 mg LY3009385 | LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| OG005 | 54 mg LY3009385 | LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 |
| OG006 | Placebo | Placebo: saline, subcutaneous (SC) injection, single dose on Day 1 |
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385 | LY3009385 exposure in terms of AUC from time 0 extrapolated to infinity (AUC[0-inf]) is summarized. | Participants who received a dose of LY3009385 and had sufficient quantifiable plasma LY3009385 concentrations in the terminal phase. | Geometric Mean | Geometric Coefficient of Variation | micrograms times hours per milliliter | Predose through Day 28 |
|
|
|
| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) | The maximum observed plasma concentration (Cmax) of LY3009385 is summarized. | Participants who received a dose of LY3009385 and had evaluable LY3009385 concentration data. | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter | Predose through Day 28 |
|
|
|
| Secondary | Change in Level of Blood Glucose Before and After a Standard Meal | The effect of LY3009385 on postprandial blood glucose was evaluated. Change from baseline area under the glucose concentration-time curve from time 0 to 6 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm. | Participants who received a dose of LY3009385 or Placebo and had evaluable blood glucose concentration data. | Mean | Standard Deviation | milligrams times hours per deciliter | Baseline, Day 5, and Day 14 |
|
|
|
| Secondary | Change in Level of C-peptide Before and After a Standard Meal | The effect of LY3009385 on postprandial c-peptide was assessed. Change from baseline area under the c-peptide concentration-time curve from time 0 to 4 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm. | Participants who received a dose of LY3009385 or Placebo and had evaluable c-peptide concentration data. | Mean | Standard Deviation | picomoles times hours per liter | Baseline, Day 5, and Day 14 |
|
|
|
| Secondary | Change in Level of Glucagon Before and After a Standard Meal | The effect of LY3009385 on postprandial glucagon levels was assessed. Change from baseline glucagon concentrations 2 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) were calculated and summarized by treatment arm. | Participants who received a dose of LY3009385 or Placebo and have evaluable glucagon concentration data. The effect of LY3009385 on postprandial glucagon concentrations was not evaluated on Day 14 for the 0.3 and 1 mg treatment arms. | Mean | Standard Deviation | picomoles per liter | Baseline, Day 14 |
|
|
|
| Secondary | Number of Participants Forming Antibody to LY3009385 | The number of participants with postbaseline detection of LY3009385treatment-emergent (TE) antidrug antibodies (ADA), defined as a 4-fold increase in the ADA titer from baseline. | Participants who received a dose of LY3009385 or Placebo. | Number | participants | Baseline through Day 28 |
|
|
|
| 0 |
| 5 |
| 5 |
| 5 |
| EG001 | 1 mg LY3009385 | LY3009385: 1 milligram (mg), subcutaneous (SC) injection, single dose on Day 1 | 0 | 6 | 6 | 6 |
| EG002 | 3 mg LY3009385 | LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 | 0 | 6 | 6 | 6 |
| EG003 | 9 mg LY3009385 | LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 | 0 | 6 | 5 | 6 |
| EG004 | 22 mg LY3009385 | LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 | 0 | 6 | 6 | 6 |
| EG005 | 54 mg LY3009385 | LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 | 0 | 5 | 5 | 5 |
| EG006 | Placebo | Placebo: saline, subcutaneous (SC) injection, single dose on Day 1 | 0 | 6 | 5 | 6 |
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Application site erythema | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Application site rash | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Catheter site erythema | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Catheter site haematoma | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hunger | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Vessel puncture site thrombosis | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| 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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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| 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 |
| Day 14 (n= 0, 0, 6, 6, 6, 5, 4) |
|
| Day 14 (n= 0, 0, 6, 6, 6, 5, 4) |
|