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| ID | Type | Description | Link |
|---|---|---|---|
| I6D-FW-SMRA | Other Identifier | Eli Lilly and Company |
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This trial is conducted in Singapore. The aim of this trial is to evaluate the safety and tolerability of the study drug in healthy people and 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 0.9% sodium chloride given as a single subcutaneous injection |
|
| LY3025876 | Experimental | Single escalating doses of LY3025876 given as subcutaneous injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3025876 | Drug | Given as a subcutaneous injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events | Possible drug-relatedness of an adverse event (AE) was in the opinion of the investigator. A summary of all serious and all other non-serious AEs, regardless of any possible causality, is located in the Reported Adverse Event Module. | Baseline up to 28 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3025876 | Area under the concentration-versus-time curve from time zero to infinity [AUC(0-∞)] of LY3025876. | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876 |
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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 | 117597 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Normal sterile saline solution (0.9% sodium chloride) administered as subcutaneous injection |
| FG001 | 0.15 mg LY3025876 | 0.15 milligrams (mg) LY3025876 administered as subcutaneous injection |
| FG002 | 0.5 mg LY3025876 | 0.5 mg LY3025876 administered as subcutaneous injection |
| FG003 | 1.5 mg LY3025876 | 1.5 mg LY3025876 administered as subcutaneous injection |
| FG004 | 5 mg LY3025876 | 5 mg LY3025876 administered as subcutaneous injection |
| FG005 | 15 mg LY3025876 | 15 mg LY3025876 administered as subcutaneous injection |
| FG006 | 30 mg LY3025876 | 30 mg LY3025876 administered as subcutaneous injection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Normal sterile saline solution (0.9% sodium chloride) administered as subcutaneous injection |
| BG001 | 0.15 mg LY3025876 | 0.15 milligrams (mg) LY3025876 administered as subcutaneous injection |
| 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 1 or More Drug-related Adverse Events or Any Serious Adverse Events | Possible drug-relatedness of an adverse event (AE) was in the opinion of the investigator. A summary of all serious and all other non-serious AEs, regardless of any possible causality, is located in the Reported Adverse Event Module. | All enrolled participants who received at least 1 dose of study drug. | Posted | Number | participants | Baseline up to 28 days post-dose |
|
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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 | Normal sterile saline solution (0.9% sodium chloride) administered as subcutaneous injection |
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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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| Drug |
Given as a subcutaneous injection |
|
| Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose |
| Number of Participants Developing Anti-LY3025876 Antibodies | Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY3025876. | Day 28 post-dose |
| Singapore |
| BG002 | 0.5 mg LY3025876 | 0.5 mg LY3025876 administered as subcutaneous injection |
| BG003 | 1.5 mg LY3025876 | 1.5 mg LY3025876 administered as subcutaneous injection |
| BG004 | 5 mg LY3025876 | 5 mg LY3025876 administered as subcutaneous injection |
| BG005 | 15 mg LY3025876 | 15 mg LY3025876 administered as subcutaneous injection |
| BG006 | 30 mg LY3025876 | 30 mg LY3025876 administered as subcutaneous injection |
| 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 | millimole per liter (mmol/L) |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per meter squared (kg/m^2) |
|
| OG002 | 0.5 mg LY3025876 | 0.5 mg LY3025876 administered as subcutaneous injection |
| OG003 | 1.5 mg LY3025876 | 1.5 mg LY3025876 administered as subcutaneous injection |
| OG004 | 5 mg LY3025876 | 5 mg LY3025876 administered as subcutaneous injection |
| OG005 | 15 mg LY3025876 | 15 mg LY3025876 administered as subcutaneous injection |
| OG006 | 30 mg LY3025876 | 30 mg LY3025876 administered as subcutaneous injection |
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3025876 | Area under the concentration-versus-time curve from time zero to infinity [AUC(0-∞)] of LY3025876. | Pharmacokinetic (PK) Population: all participants who received at least 1 dose of study drug and had evaluable AUC(0-∞) PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter (ng*h/mL) | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose |
|
|
|
| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876 | PK Population: all participants who received at least 1 dose of study drug and had evaluable Cmax PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose |
|
|
|
| Secondary | Number of Participants Developing Anti-LY3025876 Antibodies | Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY3025876. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | Day 28 post-dose |
|
|
|
| 0 |
| 6 |
| 4 |
| 6 |
| EG001 | 0.15 mg LY3025876 | 0.15 milligrams (mg) LY3025876 administered as subcutaneous injection | 0 | 6 | 2 | 6 |
| EG002 | 0.5 mg LY3025876 | 0.5 mg LY3025876 administered as subcutaneous injection | 0 | 6 | 3 | 6 |
| EG003 | 1.5 mg LY3025876 | 1.5 mg LY3025876 administered as subcutaneous injection | 0 | 6 | 1 | 6 |
| EG004 | 5 mg LY3025876 | 5 mg LY3025876 administered as subcutaneous injection | 0 | 5 | 2 | 5 |
| EG005 | 15 mg LY3025876 | 15 mg LY3025876 administered as subcutaneous injection | 0 | 6 | 3 | 6 |
| EG006 | 30 mg LY3025876 | 30 mg LY3025876 administered as subcutaneous injection | 0 | 6 | 5 | 6 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Application site erythema | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hunger | 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 |
|
| Thirst | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
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