Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGLY3025876
Given as a subcutaneous injection
DRUGPlacebo
Given as a subcutaneous injection
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
* Must be either a healthy male or a healthy female who cannot become pregnant * Have a body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m\^2), inclusive, at screening
Exclusion criteria
* Are allergic to LY3025876 or related compounds * Have a history of significant disease that may affect the actions of drugs or may pose a risk when taking the study medication * Have a history of developing allergies, asthma, severe drug allergies (symptoms including, but not limited to, itching, red rashes, sores on the skin, scaling and shedding of skin), allergies or reactions to more than one drug, or have had bad reactions to skin creams containing corticosteroids. Corticosteroids are mainly used to control inflammation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events | Baseline up to 28 days post-dose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3025876 | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose | Area under the concentration-versus-time curve from time zero to infinity \[AUC(0-∞)\] of LY3025876. |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876 | 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 | Day 28 post-dose | Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY3025876. |
Countries
Singapore
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Normal sterile saline solution (0.9% sodium chloride) administered as subcutaneous injection | 6 |
| 0.15 mg LY3025876 0.15 milligrams (mg) LY3025876 administered as subcutaneous injection | 6 |
| 0.5 mg LY3025876 0.5 mg LY3025876 administered as subcutaneous injection | 6 |
| 1.5 mg LY3025876 1.5 mg LY3025876 administered as subcutaneous injection | 6 |
| 5 mg LY3025876 5 mg LY3025876 administered as subcutaneous injection | 5 |
| 15 mg LY3025876 15 mg LY3025876 administered as subcutaneous injection | 6 |
| 30 mg LY3025876 30 mg LY3025876 administered as subcutaneous injection | 6 |
| Total | 41 |
Baseline characteristics
| Characteristic | 30 mg LY3025876 | Placebo | 0.15 mg LY3025876 | 0.5 mg LY3025876 | 1.5 mg LY3025876 | Total | 5 mg LY3025876 | 15 mg LY3025876 |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 31.3 years STANDARD_DEVIATION 7.2 | 32.3 years STANDARD_DEVIATION 7.9 | 36.8 years STANDARD_DEVIATION 8.8 | 33.7 years STANDARD_DEVIATION 9.3 | 32.7 years STANDARD_DEVIATION 3.8 | 32.1 years STANDARD_DEVIATION 7.2 | 29.4 years STANDARD_DEVIATION 7.4 | 27.8 years STANDARD_DEVIATION 4.5 |
| Body Mass Index (BMI) | 25.53 kilogram per meter squared (kg/m^2) STANDARD_DEVIATION 2.91 | 28.35 kilogram per meter squared (kg/m^2) STANDARD_DEVIATION 2.31 | 23.88 kilogram per meter squared (kg/m^2) STANDARD_DEVIATION 4.91 | 26.22 kilogram per meter squared (kg/m^2) STANDARD_DEVIATION 5.65 | 25.12 kilogram per meter squared (kg/m^2) STANDARD_DEVIATION 1.99 | 25.54 kilogram per meter squared (kg/m^2) STANDARD_DEVIATION 4.23 | 26.78 kilogram per meter squared (kg/m^2) STANDARD_DEVIATION 6.62 | 23.10 kilogram per meter squared (kg/m^2) STANDARD_DEVIATION 3.48 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 41 Participants | 5 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fasting Blood Glucose | 4.57 millimole per liter (mmol/L) STANDARD_DEVIATION 0.36 | 4.68 millimole per liter (mmol/L) STANDARD_DEVIATION 0.17 | 4.45 millimole per liter (mmol/L) STANDARD_DEVIATION 0.4 | 4.43 millimole per liter (mmol/L) STANDARD_DEVIATION 0.4 | 4.97 millimole per liter (mmol/L) STANDARD_DEVIATION 0.27 | 4.57 millimole per liter (mmol/L) STANDARD_DEVIATION 0.38 | 4.68 millimole per liter (mmol/L) STANDARD_DEVIATION 0.33 | 4.20 millimole per liter (mmol/L) STANDARD_DEVIATION 0.35 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 41 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 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 | 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 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 | 0 Participants | 0 Participants |
| Region of Enrollment Singapore | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 41 participants | 5 participants | 6 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 6 Participants | 40 Participants | 5 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 | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 6 | 2 / 6 | 3 / 6 | 1 / 6 | 2 / 5 | 3 / 6 | 5 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 6 | 0 / 6 |
Outcome results
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.
Time frame: Baseline up to 28 days post-dose
Population: All enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events | Serious AEs | 0 participants |
| Placebo | Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events | Other nonserious AEs | 0 participants |
| 0.15 mg LY3025876 | Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events | Serious AEs | 0 participants |
| 0.15 mg LY3025876 | Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events | Other nonserious AEs | 0 participants |
| 0.5 mg LY3025876 | Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events | Serious AEs | 0 participants |
| 0.5 mg LY3025876 | Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events | Other nonserious AEs | 1 participants |
| 1.5 mg LY3025876 | Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events | Serious AEs | 0 participants |
| 1.5 mg LY3025876 | Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events | Other nonserious AEs | 1 participants |
| 5 mg LY3025876 | Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events | Serious AEs | 0 participants |
| 5 mg LY3025876 | Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events | Other nonserious AEs | 1 participants |
| 15 mg LY3025876 | Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events | Serious AEs | 0 participants |
| 15 mg LY3025876 | Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events | Other nonserious AEs | 0 participants |
| 30 mg LY3025876 | Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events | Serious AEs | 0 participants |
| 30 mg LY3025876 | Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events | Other nonserious AEs | 1 participants |
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.
Time frame: Day 28 post-dose
Population: All randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Developing Anti-LY3025876 Antibodies | 0 participants |
| 0.15 mg LY3025876 | Number of Participants Developing Anti-LY3025876 Antibodies | 0 participants |
| 0.5 mg LY3025876 | Number of Participants Developing Anti-LY3025876 Antibodies | 0 participants |
| 1.5 mg LY3025876 | Number of Participants Developing Anti-LY3025876 Antibodies | 0 participants |
| 5 mg LY3025876 | Number of Participants Developing Anti-LY3025876 Antibodies | 0 participants |
| 15 mg LY3025876 | Number of Participants Developing Anti-LY3025876 Antibodies | 0 participants |
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.
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose
Population: Pharmacokinetic (PK) Population: all participants who received at least 1 dose of study drug and had evaluable AUC(0-∞) PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3025876 | NA nanograms*hour per milliliter (ng*h/mL) | — |
| 0.15 mg LY3025876 | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3025876 | 62.5 nanograms*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 11.9 |
| 0.5 mg LY3025876 | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3025876 | 180 nanograms*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 17 |
| 1.5 mg LY3025876 | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3025876 | 595 nanograms*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 8.74 |
| 5 mg LY3025876 | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3025876 | 1920 nanograms*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 9.99 |
| 15 mg LY3025876 | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3025876 | 3780 nanograms*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 25.1 |
Secondary
Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose
Population: PK Population: all participants who received at least 1 dose of study drug and had evaluable Cmax PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876 | 1.88 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 35.2 |
| 0.15 mg LY3025876 | Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876 | 7.25 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 53.1 |
| 0.5 mg LY3025876 | Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876 | 16.0 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 18.2 |
| 1.5 mg LY3025876 | Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876 | 55.0 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 26.5 |
| 5 mg LY3025876 | Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876 | 187 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 22.9 |
| 15 mg LY3025876 | Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876 | 347 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 19.6 |