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| ID | Type | Description | Link |
|---|---|---|---|
| I2R-MC-BIDF | Other Identifier | Eli Lilly and Company |
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This study will include 2 groups (cohorts) of participants:
In Cohort A, this study will look at the amount of LY2605541 that is present in the body after it is injected in 3 different locations in the body of the same participant. At least 16 days will pass between each injection.
In Cohort B, the study will look at how the body absorbs, distributes, and disposes of LY2605541 in participants aged 65 and over.
Participants may enroll in only one cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2605541: Cohort A (Injection site: Abdomen) | Experimental | Participants ≤55 years of age will receive 1 subcutaneous (SC) injection of 0.5 Units per kilogram (U/kg) of LY2605541 in the abdominal wall on Day 1 in 1 of 3 treatment periods. There was a washout period of 16-28 days between each treatment period. |
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| LY2605541: Cohort A (Injection site: Upper Arm) | Experimental | Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 in 1 of 3 treatment periods. There was a washout period of 16-28 days between each treatment period. |
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| LY2605541: Cohort A (Injection site: Thigh) | Experimental | Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 in 1 of 3 treatment periods. There was a washout period of 16-28 days between each treatment period. |
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| LY2605541: Cohort B (Injection site: Abdomen) | Experimental | Participants ≥65 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2605541 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration-Time Curve (AUC): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A) | AUC from time zero to infinity (AUC(0-∞)) of LY2605541 was evaluated across injection sites (abdominal wall, arm, and thigh). | Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose |
| Pharmacokinetics: Observed Maximum Plasma Concentration (Cmax): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A) | Cmax of LY2605541 was evaluated across injection sites (abdominal wall, arm, and thigh). | Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose |
| Pharmacokinetics: Area Under the Concentration-Time Curve (AUC): Elderly Participants (≥65 Years of Age) Versus Participants ≤55 Years of Age (Abdominal Injection) | AUC(0-∞) for LY2605541 was evaluated. | Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose |
| Pharmacokinetics: Maximum Plasma Concentration (Cmax): Elderly Participants (≥65 Years of Age) Versus Participants ≤55 Years of Age (Abdominal Injection) | Cmax of LY2605541 was evaluated. | Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics: Total Amount of Glucose Infused (Gtot): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A) | Gtot was evaluated across injection sites (abdominal wall, arm, and thigh). | Predose up to 24 hours post clamp procedure in all treatment periods |
| Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A) |
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Inclusion Criteria:
Exclusion Criteria:
Healthy Participants - Cohort A
Elderly Participants - Cohort B
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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. | Dallas | Texas |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2605541: Cohort A (Participants ≤55 Years of Age) | Participants ≤55 years of age were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C). Each intervention was separated by a 16-28 day washout. Intervention A: participants ≤55 years of age received 1 subcutaneous (SC) injection of 0.5 Units per kilogram (U/kg) of LY2605541 in the abdominal wall on Day 1 of the treatment period. Intervention B: participants ≤55 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 of the treatment period. Intervention C: participants ≤55 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 of the treatment period. |
| FG001 | LY2605541: Cohort B (Participants ≥65 Years of Age) | Participants ≥65 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention A |
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| Washout (16-28 Days) |
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| Intervention B |
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| Washout (16-28 Days) |
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| Intervention C |
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All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | LY2605541: Cohort A (Participants ≤55 Years of Age) | Participants ≤55 years of age were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C). Each intervention was separated by a 16-28 day washout. Intervention A: participants ≤55 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1 of the treatment period. Intervention B: participants ≤55 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 of the treatment period. Intervention C: participants ≤55 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 of the treatment period. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Pharmacokinetics: Area Under the Concentration-Time Curve (AUC): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A) | AUC from time zero to infinity (AUC(0-∞)) of LY2605541 was evaluated across injection sites (abdominal wall, arm, and thigh). | Participants in Cohort A who received LY2605541 and had evaluable AUC(0-∞) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomoles*hours/liter (pmol*h/L) | Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose |
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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 | LY2605541: Cohort A (Injection Site: Abdomen) | Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1 in 1 of 3 treatment periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | 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 |
|---|---|
| C587357 | LY2605541 |
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Rmax was evaluated across injection sites (abdominal wall, arm, and thigh). |
| Predose up to 24 hours post clamp procedure in all treatment periods |
| United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | LY2605541: Cohort B (Participants ≥65 Years of Age) | Participants ≥65 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 in 1 of 3 treatment periods. |
| OG002 | LY2605541: Cohort A (Injection Site: Thigh) | Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 in 1 of 3 treatment periods. |
|
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| Primary | Pharmacokinetics: Observed Maximum Plasma Concentration (Cmax): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A) | Cmax of LY2605541 was evaluated across injection sites (abdominal wall, arm, and thigh). | Participants in Cohort A who received LY2605541 and had evaluable Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomoles/liter (pmol/L) | Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose |
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| Primary | Pharmacokinetics: Area Under the Concentration-Time Curve (AUC): Elderly Participants (≥65 Years of Age) Versus Participants ≤55 Years of Age (Abdominal Injection) | AUC(0-∞) for LY2605541 was evaluated. | Participants in Cohort A and B who received LY2605541 in the abdomen and had evaluable AUC(0-∞) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol*h/L | Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose |
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| Primary | Pharmacokinetics: Maximum Plasma Concentration (Cmax): Elderly Participants (≥65 Years of Age) Versus Participants ≤55 Years of Age (Abdominal Injection) | Cmax of LY2605541 was evaluated. | Participants in Cohort A and B who received LY2605541 in the abdomen and had evaluable Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol/L | Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose |
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| Secondary | Pharmacodynamics: Total Amount of Glucose Infused (Gtot): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A) | Gtot was evaluated across injection sites (abdominal wall, arm, and thigh). | Participants in Cohort A who received LY2605541 and had evaluable Gtot data. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams/kilograms (mg/kg) | Predose up to 24 hours post clamp procedure in all treatment periods |
|
|
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| Secondary | Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A) | Rmax was evaluated across injection sites (abdominal wall, arm, and thigh). | Participants in Cohort A who received LY2605541 and had evaluable Rmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams/minute/kilogram (mg/min/kg) | Predose up to 24 hours post clamp procedure in all treatment periods |
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|
| 0 |
| 30 |
| 3 |
| 30 |
| EG001 | LY2605541: Cohort A (Injection Site: Upper Arm) | Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 in 1 of 3 treatment periods. | 0 | 30 | 5 | 30 |
| EG002 | LY2605541: Cohort A (Injection Site: Thigh) | Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 in 1 of 3 treatment periods. | 0 | 30 | 13 | 30 |
| EG003 | LY2605541: Cohort B (Injection Site: Abdomen) | Participants ≥65 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1. | 0 | 22 | 7 | 22 |
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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