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| ID | Type | Description | Link |
|---|---|---|---|
| I1K-MC-GLUG | Other Identifier | Eli Lilly and Company |
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The main purpose of this study was to evaluate the safety and tolerability of LY2405319. It was given as a daily injection under the skin to participants with type 2 diabetes mellitus (T2DM) for 28 days. This study determined how long the drug stays in the body and how it affects blood sugar levels. After screening, the study lasted about 2 months for each participant. Participants continued their prestudy regimen of diet and exercise alone or in combination with metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received placebo-matching LY2405319 injected subcutaneously (SC) once daily for 28 days. |
|
| 3 mg LY2405319 | Experimental | Participants received 3 milligrams (mg) LY2405319 injected SC once daily for 28 days. |
|
| 10 mg LY2405319 | Experimental | Participants received 10 mg LY2405319 injected SC once daily for 28 days. |
|
| 20 mg LY2405319 | Experimental | Participants received 20 mg LY2405319 injected SC once daily for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2405319 | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 11.0. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Baseline through Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Day 28 in Fasting Glucose | Change from baseline to Day 28 in fasting blood glucose is presented. The predose fasting blood glucose measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as a random effect. | Baseline, Day 28 |
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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. | Cypress | California | 90630 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3 mg LY2405319 | 3 milligrams (mg) LY2405319 injected SC once daily for 28 days. |
| FG001 | 10 mg LY2405319 | 10 mg LY2405319 injected SC once daily for 28 days. |
| FG002 | 20 mg LY2405319 | 20 mg LY2405319 injected SC once daily for 28 days. |
| FG003 | Placebo | Placebo-matching LY2405319 injected subcutaneously (SC) once daily for 28 days. |
| FG004 | All Randomized Participants | All participants randomized in the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization Period |
|
| ||||||||||||||||||
| Treatment Period |
|
All participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 3 mg LY2405319 | 3 mg LY2405319 injected SC once daily for 28 days. |
| BG001 | 10 mg LY2405319 | 10 mg LY2405319 injected SC once daily for 28 days. |
| 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 Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 11.0. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | All participants who received at least 1 dose of study drug. | Posted | Number | number of participants | Baseline through Day 56 |
|
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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 | 3 mg LY2405319 | Participants received 3 mg LY2405319 injected SC once daily for 28 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Optic ischaemic neuropathy | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 11.0 | 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 |
|---|---|
| C585266 | LY2405319 |
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| Placebo | Drug | Administered SC |
|
| 7 Point Self-monitored Blood Glucose (SMBG) | The daily mean of the 7-point SMBG values is presented. Seven-point glucose profiles were measured by participants at baseline and at Week 4. The 7-point SMBG mean on Days -5, -4, or -3 served as the baseline value; the 7-point SMBG mean on Days 24, 25, or 26 served as the Week 4 value. Blood glucose was measured before and 2 hours after each meal and at bedtime. | Baseline (Day -5, -4, or -3) and Week 4 (Days 24, 25, or 26) |
| Change From Baseline to Week 4 in Glucose Area Under the Curve (AUC) | Change from baseline to Week 4 in glucose AUC during an oral glucose tolerance test (OGTT) is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as fixed effect and baseline as covariate. | Predose and 2 hours postdose (Baseline, Week 4) |
| Change From Baseline to Week 4 in Insulin Area Under the Curve (AUC) | Change from baseline to Week 4 in insulin AUC during an OGTT is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as fixed effect and baseline as covariate. | Predose and 2 hours postdose (Baseline, Week 4) |
| Change From Baseline to Week 4 in C-peptide Area Under the Curve (AUC) | Change from baseline to Week 4 in C-peptide AUC during an OGTT is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as a fixed effect and baseline as covariate. | Predose and 2 hours postdose (Baseline, Week 4) |
| Change From Baseline to Day 28 in Fasting Lipid Profile | Change from baseline to Day 28 in fasting lipids, including cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), and triglycerides is presented. The predose measurement for each variable on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as a random effect. | Baseline, Day 28 |
| Change From Baseline to Day 28 in Body Weight | Change from baseline to Day 28 in body weight is presented. The predose body weight measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, time, and treatment times time, treatment times day, and treatment times day times time were fixed effects; baseline as covariate; and participant as a random effect. | Baseline, Day 28 |
| Change From Baseline to Day 28 in Adiponectin | Change from baseline to Day 28 in adiponectin is presented. The predose adiponectin measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, treatment times day as fixed effects, baseline as covariate, and participant as random effect. | Baseline, Day 28 |
| Change From Baseline to Day 28 in C-Reactive Protein | Change from baseline to Day 28 in C-reactive protein is presented. The predose C-reactive protein measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as random effect. | Baseline, Day 28 |
| Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2405319 | AUC for LY2405319 is presented. Data represent AUC for 1 dosing interval at steady state. Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 28. | Predose through Day 28 (48 hours postdose) |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2405319 | Cmax of LY2405319 is presented. Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 28. | Predose through Day 28 (48 hours postdose) |
| The Number of Participants With Anti-LY2405319 Antibodies | The number of participants that tested positive for anti-LY2405319 antibodies is presented. | Day 1 through Day 56 |
| Change From Baseline to Day 28 in Eating Inventory for Cognitive Restraint of Eating, Disinhibition, and Hunger | Change from baseline to Day 28 in Eating Inventory (EI) subscales are presented. The EI is a 51-item inventory that measures dietary restraint (the cognitive intention to restrict energy intake; scores range from 0 to 21), disinhibition (the tendency to episodically overeat, often in response to external cues; scores range from 0 to 16), and perceived hunger (scores range from 0 to 14). A low score indicates a low exhibition of behavior and a high score indicates a high exhibition of behavior. The measurement for each variable obtained on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate. | Baseline, Day 28 |
| Change From Baseline to Day 28 in the Food Preference Questionnaire (FPQ) Score | The table below represents the change from baseline in FPQ total score. The FPQ was administered to assess overall preference for foods of different macronutrient contents utilizing a macronutrient self-selection paradigm. Participants rated their preference on a range from 1 to 9 with 1 (dislike extremely) to 9 (like extremely) for a battery of 72 commonly consumed foods with fat content varying significantly in sugar, complex carbohydrates, and protein. The total score was calculated by averaging preference scores of 72 items. A low mean score of 1 to 9 scale indicate a low preference for the foods listed and a high mean score indicate a high preference for the foods listed. The FPQ measurement on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate. | Baseline, Day 28 |
| Change From Baseline to Day 28 in The Patient Health Questionnaire (PHQ-9) Score | Change from baseline to Day 28 in the PHQ-9 total score is presented. Participants were asked to score the severity of depressive symptoms over the last 2 weeks. Items were scored 0 (not at all), 1 (several days), 2 (half of the days), or 3 (nearly every day). The total PHQ-9 score is the sum of the score for each item and range from 0 to 27. A score of 0 means low depression severity and a score of 27 means high depression severity. Depression severity will be given a quality rating based on the total PHQ-9 score, as follows: None (0-4); Mild (5-9); Moderate (10-14); Moderately severe (15-19); and Severe (20-27). The PHQ-9 measurement obtained on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate. | Baseline, Day 28 |
| United States |
| 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. | Tustin | California | 92780 | United States |
| 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. | DeLand | Florida | 32720 | United States |
| 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. | Miramar | Florida | 33025 | United States |
| 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. | Cincinnati | Ohio | 45212 | United States |
| 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. | Portland | Oregon | 97239 | United States |
| 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. | San Antonio | Texas | 78229 | United States |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | 20 mg LY2405319 | 20 mg LY2405319 injected SC once daily for 28 days. |
| BG003 | Placebo | Placebo-matching LY2405319 injected subcutaneously (SC) once daily for 28 days. |
| BG004 | 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 |
|
| 10 mg LY2405319 |
Participants received 10 mg LY2405319 injected SC once daily for 28 days. |
| OG002 | 20 mg LY2405319 | Participants received 20 mg LY2405319 injected SC once daily for 28 days. |
| OG003 | Placebo | Participants received placebo-matching LY2405319 injected SC once daily for 28 days. |
|
|
| Secondary | Change From Baseline to Day 28 in Fasting Glucose | Change from baseline to Day 28 in fasting blood glucose is presented. The predose fasting blood glucose measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as a random effect. | Participants who received at least 1 dose of study drug with evaluable blood glucose data. | Posted | Least Squares Mean | 90% Confidence Interval | milligrams per deciliter (mg/dL) | Baseline, Day 28 |
|
|
|
| Secondary | 7 Point Self-monitored Blood Glucose (SMBG) | The daily mean of the 7-point SMBG values is presented. Seven-point glucose profiles were measured by participants at baseline and at Week 4. The 7-point SMBG mean on Days -5, -4, or -3 served as the baseline value; the 7-point SMBG mean on Days 24, 25, or 26 served as the Week 4 value. Blood glucose was measured before and 2 hours after each meal and at bedtime. | All participants who received at least 1 dose of study drug with evaluable 7-Point SMBG data. | Posted | Mean | Standard Error | mg/dL | Baseline (Day -5, -4, or -3) and Week 4 (Days 24, 25, or 26) |
|
|
|
| Secondary | Change From Baseline to Week 4 in Glucose Area Under the Curve (AUC) | Change from baseline to Week 4 in glucose AUC during an oral glucose tolerance test (OGTT) is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as fixed effect and baseline as covariate. | All participants who received at least 1 dose of study drug with evaluable glucose AUC data. | Posted | Least Squares Mean | 90% Confidence Interval | milligrams*hr per deciliter (mg*hr/dL) | Predose and 2 hours postdose (Baseline, Week 4) |
|
|
|
| Secondary | Change From Baseline to Week 4 in Insulin Area Under the Curve (AUC) | Change from baseline to Week 4 in insulin AUC during an OGTT is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as fixed effect and baseline as covariate. | All participants who received at least 1 dose of study drug with evaluable insulin (AUC) data. | Posted | Least Squares Mean | 90% Confidence Interval | micro International units*hour/mL | Predose and 2 hours postdose (Baseline, Week 4) |
|
|
|
| Secondary | Change From Baseline to Week 4 in C-peptide Area Under the Curve (AUC) | Change from baseline to Week 4 in C-peptide AUC during an OGTT is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as a fixed effect and baseline as covariate. | All participants who received at least 1 dose of study drug with evaluable C-peptide AUC data. | Posted | Least Squares Mean | 90% Confidence Interval | nanograms*hours/milliliter (ng*hr/mL) | Predose and 2 hours postdose (Baseline, Week 4) |
|
|
|
| Secondary | Change From Baseline to Day 28 in Fasting Lipid Profile | Change from baseline to Day 28 in fasting lipids, including cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), and triglycerides is presented. The predose measurement for each variable on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as a random effect. | All participants who received at least 1 dose of study drug with evaluable fasting lipid (ie, cholesterol, LDL-C, HDL-C, and triglyceride) data. | Posted | Least Squares Mean | 90% Confidence Interval | milligrams per deciliter (mg/dL) | Baseline, Day 28 |
|
|
|
| Secondary | Change From Baseline to Day 28 in Body Weight | Change from baseline to Day 28 in body weight is presented. The predose body weight measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, time, and treatment times time, treatment times day, and treatment times day times time were fixed effects; baseline as covariate; and participant as a random effect. | All participants who received at least 1 dose of study drug with evaluable body weight data. | Posted | Least Squares Mean | 90% Confidence Interval | kilograms (kg) | Baseline, Day 28 |
|
|
|
| Secondary | Change From Baseline to Day 28 in Adiponectin | Change from baseline to Day 28 in adiponectin is presented. The predose adiponectin measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, treatment times day as fixed effects, baseline as covariate, and participant as random effect. | All participants who received at least 1 dose of study drug with evaluable adiponectin data. | Posted | Least Squares Mean | 90% Confidence Interval | nanograms per milliliter (ng/mL) | Baseline, Day 28 |
|
|
|
| Secondary | Change From Baseline to Day 28 in C-Reactive Protein | Change from baseline to Day 28 in C-reactive protein is presented. The predose C-reactive protein measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as random effect. | All participants who received at least 1 dose of study drug with evaluable C-reactive protein data. | Posted | Least Squares Mean | 90% Confidence Interval | milligrams per liter (mg/L) | Baseline, Day 28 |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2405319 | AUC for LY2405319 is presented. Data represent AUC for 1 dosing interval at steady state. Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 28. | All participants who received at least 1 dose of study drug with evaluable AUC of LY2405319 data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours/milliliter (ng*hr/mL) | Predose through Day 28 (48 hours postdose) |
|
|
|
| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) of LY2405319 | Cmax of LY2405319 is presented. Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 28. | All participants who received at least 1 dose of study drug with evaluable Cmax of LY2405319 data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Predose through Day 28 (48 hours postdose) |
|
|
|
| Secondary | The Number of Participants With Anti-LY2405319 Antibodies | The number of participants that tested positive for anti-LY2405319 antibodies is presented. | All participants who received at least 1 dose of study drug with evaluable anti-LY2405319 antibody data. | Posted | Number | number of participants | Day 1 through Day 56 |
|
|
|
| Secondary | Change From Baseline to Day 28 in Eating Inventory for Cognitive Restraint of Eating, Disinhibition, and Hunger | Change from baseline to Day 28 in Eating Inventory (EI) subscales are presented. The EI is a 51-item inventory that measures dietary restraint (the cognitive intention to restrict energy intake; scores range from 0 to 21), disinhibition (the tendency to episodically overeat, often in response to external cues; scores range from 0 to 16), and perceived hunger (scores range from 0 to 14). A low score indicates a low exhibition of behavior and a high score indicates a high exhibition of behavior. The measurement for each variable obtained on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate. | All participants who received at least 1 dose of study drug with evaluable EI data. | Posted | Least Squares Mean | 90% Confidence Interval | units on a scale | Baseline, Day 28 |
|
|
|
| Secondary | Change From Baseline to Day 28 in the Food Preference Questionnaire (FPQ) Score | The table below represents the change from baseline in FPQ total score. The FPQ was administered to assess overall preference for foods of different macronutrient contents utilizing a macronutrient self-selection paradigm. Participants rated their preference on a range from 1 to 9 with 1 (dislike extremely) to 9 (like extremely) for a battery of 72 commonly consumed foods with fat content varying significantly in sugar, complex carbohydrates, and protein. The total score was calculated by averaging preference scores of 72 items. A low mean score of 1 to 9 scale indicate a low preference for the foods listed and a high mean score indicate a high preference for the foods listed. The FPQ measurement on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate. | All participants who received at least 1 dose of study drug with evaluable FPQ data. | Posted | Least Squares Mean | 90% Confidence Interval | units on a scale | Baseline, Day 28 |
|
|
|
| Secondary | Change From Baseline to Day 28 in The Patient Health Questionnaire (PHQ-9) Score | Change from baseline to Day 28 in the PHQ-9 total score is presented. Participants were asked to score the severity of depressive symptoms over the last 2 weeks. Items were scored 0 (not at all), 1 (several days), 2 (half of the days), or 3 (nearly every day). The total PHQ-9 score is the sum of the score for each item and range from 0 to 27. A score of 0 means low depression severity and a score of 27 means high depression severity. Depression severity will be given a quality rating based on the total PHQ-9 score, as follows: None (0-4); Mild (5-9); Moderate (10-14); Moderately severe (15-19); and Severe (20-27). The PHQ-9 measurement obtained on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate. | All participants who received at least 1 dose of study drug with evaluable PHQ-9 data. | Posted | Least Squares Mean | 90% Confidence Interval | units on a scale | Baseline, Day 28 |
|
|
|
| 0 |
| 11 |
| 7 |
| 11 |
| EG001 | 10 mg LY2405319 | Participants received 10 mg LY2405319 injected SC once daily for 28 days. | 0 | 10 | 8 | 10 |
| EG002 | 20 mg LY2405319 | Participants received 20 mg LY2405319 injected SC once daily for 28 days. | 2 | 15 | 11 | 15 |
| EG003 | Placebo | Participants received placebo-matching LY2405319 injected SC once daily for 28 days. | 1 | 10 | 9 | 10 |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Application site rash | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site inflammation | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site irritation | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site urticaria | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Blood calcium increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
| D004700 | Endocrine System Diseases |
| Week 4 (Days 24, 25, or 26) |
|
| LDL-C (n=10, n=8, n=13, n=7) |
|
| HDL-C (n=10, n=8, n=13, n=8) |
|
| Triglycerides (n=10, n=8, n=13, n=8) |
|
| Disinhibition |
|
| Hunger |
|