Healthy
Conditions
Brief summary
This study is being conducted to determine the side effects related to LY3493269 given as a single injection to healthy participants. Blood tests will be performed to check how much LY3493269 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of LY3493269 or placebo. The study will last up to approximately 71 days for each participant, including screening.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Overtly healthy male or a female who cannot get pregnant * Have a body mass index (BMI) between 19 and 40 kilograms per square meter (kg/m²), inclusive, at screening * Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study * Have veins suitable for ease of blood sampling
Exclusion criteria
* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study * Have previously completed or withdrawn from this study * Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking during the inpatient stay in the study * Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study * Have been treated with weight loss medications within 3 months of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline through final follow-up (Up To Day 43) | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0-∞) of LY3493269 | Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 and early termination | Pharmacokinetics (PK): Area Under the Concentration time curve from time zero to infinity (AUC 0-∞) of LY3493269 |
| PK: Maximum Concentration (Cmax) of LY3493269 | Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early termination | PK: Maximum Concentration (Cmax) of LY3493269 |
| PK: Time to Maximum Concentration (Tmax) of LY3493269 | Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early termination | PK: Time to Maximum Concentration (Tmax) of LY3493269 |
Countries
Singapore
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo SC Participants received Placebo subcutaneously(SC). | 6 |
| 0.15 mg LY3493269 SC Participants received 0.15 mg LY3493269 SC. | 6 |
| 0.5 mg LY3493269 SC Participants received 0.5 mg LY3493269 SC. | 6 |
| 0.5 mg LY3493269 IV Participants received 0.5 mg LY3493269 intravenously (IV). | 6 |
| 1.5 mg LY3493269 SC Participants received 1.5 mg LY3493269 SC. | 6 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Investigator Decision | 0 | 0 | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | Total | 0.15 mg LY3493269 SC | 0.5 mg LY3493269 SC | Placebo SC | 0.5 mg LY3493269 IV | 1.5 mg LY3493269 SC |
|---|---|---|---|---|---|---|
| Age, Continuous | 40.5 years STANDARD_DEVIATION 11.2 | 40.8 years STANDARD_DEVIATION 8.6 | 43.5 years STANDARD_DEVIATION 8.5 | 47.0 years STANDARD_DEVIATION 13.9 | 36.5 years STANDARD_DEVIATION 12.7 | 34.7 years STANDARD_DEVIATION 9.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 30 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Singapore | 30 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 30 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 3 / 6 | 5 / 6 | 6 / 6 | 6 / 6 | 6 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Baseline through final follow-up (Up To Day 43)
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo SC | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 0.15 mg LY3493269 SC | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 0.5 mg LY3493269 SC | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 0.5 mg LY3493269 IV | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 1.5 mg LY3493269 SC | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
Secondary
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0-∞) of LY3493269
Pharmacokinetics (PK): Area Under the Concentration time curve from time zero to infinity (AUC 0-∞) of LY3493269
Time frame: Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 and early termination
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo SC | Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0-∞) of LY3493269 | 4990 nanograms*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 26 |
| 0.15 mg LY3493269 SC | Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0-∞) of LY3493269 | 21800 nanograms*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 24 |
| 0.5 mg LY3493269 SC | Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0-∞) of LY3493269 | 24600 nanograms*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 23 |
| 0.5 mg LY3493269 IV | Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0-∞) of LY3493269 | 7300 nanograms*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 21 |
Secondary
PK: Maximum Concentration (Cmax) of LY3493269
PK: Maximum Concentration (Cmax) of LY3493269
Time frame: Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early termination
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo SC | PK: Maximum Concentration (Cmax) of LY3493269 | 16.4 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 19 |
| 0.15 mg LY3493269 SC | PK: Maximum Concentration (Cmax) of LY3493269 | 68.8 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 40 |
| 0.5 mg LY3493269 SC | PK: Maximum Concentration (Cmax) of LY3493269 | 181 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 15 |
| 0.5 mg LY3493269 IV | PK: Maximum Concentration (Cmax) of LY3493269 | 247 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 27 |
Secondary
PK: Time to Maximum Concentration (Tmax) of LY3493269
PK: Time to Maximum Concentration (Tmax) of LY3493269
Time frame: Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early termination
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo SC | PK: Time to Maximum Concentration (Tmax) of LY3493269 | 12.01 hours (hr) |
| 0.15 mg LY3493269 SC | PK: Time to Maximum Concentration (Tmax) of LY3493269 | 12.06 hours (hr) |
| 0.5 mg LY3493269 SC | PK: Time to Maximum Concentration (Tmax) of LY3493269 | 0.39 hours (hr) |
| 0.5 mg LY3493269 IV | PK: Time to Maximum Concentration (Tmax) of LY3493269 | 12.00 hours (hr) |