Healthy Volunteers
Conditions
Brief summary
The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3084077 in healthy participants. The study will also 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. The study is expected to last approximately 8 weeks for each participant.
Interventions
DRUGPlacebo
Given as a SC injection.
DRUGLY3084077
Given as a SC 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
* Have normal blood pressure * Must be a healthy male or female who cannot become pregnant * Have a body mass index (BMI) of 18.5 to 40.0 kg/m\^2, inclusive, at screening
Exclusion criteria
* Have known allergies to fibroblast growth factor-21 (FGF21) analogues, glucagon-like peptide-1 (GLP1), GLP1-analogues or other related compounds * Have previous exposure to FGF21 analogues or GLP1 analogues * Have received live vaccine(s) within 1 month of screening, or intend to during the study * Have previously completed or withdrawn from this study * Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that in the opinion of the doctor, could make it unsafe to participate, or interfere with understanding the results of the study * Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing * Have problems with the immune system, due to a disease or treatment * Have a personal or family history of medullary thyroid carcinoma (MTC) or have multiple endocrine neoplasia syndrome type 2 * Have a history of pancreatitis
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 | Pre-dose, Up to Day 190 | An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077 | Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose | — |
| Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides | Baseline, Up to Day 15 | Percent change=(measure at time t-measure at baseline)/measure at baseline\*100%). Least Square Means (LS means) were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction. |
| PD: Change From Baseline in Fasting Insulin | Baseline, Up to Day 15 | LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction. |
| PD: Change From Baseline in Weight | Baseline, Up to Day 15 | — |
| Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077 | Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose | — |
| PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal | Baseline, Day 2 | LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction. |
| PD: Change From Baseline to Day 2 in Fasting Glucagon | Baseline, Up to Day 2 | LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction. |
| Number of Participants Developing Anti-LY3084077 Antibodies | Pre-dose, Up to Day 190 | The number of participants with 1:4 baseline and postbaseline positive anti-LY3084077 antibody titers. |
| PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal | Baseline, Day 2 | LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction. |
Countries
Singapore
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Cohort 1 Single dose of placebo matching LY3084077 administered subcutaneously (SC). | 6 |
| LY3084077 Cohort 2 1 mg single dose of LY3084077 administered SC. | 6 |
| LY3084077 Cohort 3 3 mg single dose of LY3084077 administered SC. | 6 |
| LY3084077 Cohort 4 10 mg single dose of LY3074077 administered SC. | 6 |
| LY3084077 Cohort 5 30 mg single dose of LY3074077 administered SC. | 6 |
| LY3084077 Cohort 6 100 mg single dose of LY3074077 administered SC. | 6 |
| LY3084077 Cohort 7 150 mg single dose of LY3074077 administered SC. | 6 |
| Total | 42 |
Baseline characteristics
| Characteristic | Placebo Cohort 1 | Total | LY3084077 Cohort 7 | LY3084077 Cohort 6 | LY3084077 Cohort 5 | LY3084077 Cohort 4 | LY3084077 Cohort 3 | LY3084077 Cohort 2 |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 35.7 years STANDARD_DEVIATION 14 | 34.4 years STANDARD_DEVIATION 10.2 | 36.3 years STANDARD_DEVIATION 4.8 | 30.5 years STANDARD_DEVIATION 5 | 40.7 years STANDARD_DEVIATION 12.6 | 32.7 years STANDARD_DEVIATION 7.4 | 34.5 years STANDARD_DEVIATION 11.2 | 30.7 years STANDARD_DEVIATION 13.2 |
| 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 | 42 Participants | 6 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 | 0 Participants | 0 Participants |
| 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 | 40 Participants | 6 Participants | 6 Participants | 6 Participants | 4 Participants | 6 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 | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Singapore | 6 Participants | 42 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 6 Participants | 40 Participants | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 6 Participants | 5 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 | 6 / 6 | 6 / 6 | 3 / 6 | 3 / 6 | 5 / 6 | 6 / 6 | 6 / 6 |
| serious Total, serious adverse events | 1 / 6 | 0 / 6 | 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
An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Time frame: Pre-dose, Up to Day 190
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Cohort 1 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 1 participants |
| LY3084077 Cohort 2 | 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 |
| LY3084077 Cohort 3 | 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 |
| LY3084077 Cohort 4 | 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 |
| LY3084077 Cohort 5 | 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 |
| LY3084077 Cohort 6 | 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 |
| LY3084077 Cohort 7 | 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
Number of Participants Developing Anti-LY3084077 Antibodies
The number of participants with 1:4 baseline and postbaseline positive anti-LY3084077 antibody titers.
Time frame: Pre-dose, Up to Day 190
Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and postbaseline antibody titers.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Cohort 1 | Number of Participants Developing Anti-LY3084077 Antibodies | 0 participants |
| LY3084077 Cohort 2 | Number of Participants Developing Anti-LY3084077 Antibodies | 1 participants |
| LY3084077 Cohort 3 | Number of Participants Developing Anti-LY3084077 Antibodies | 0 participants |
| LY3084077 Cohort 4 | Number of Participants Developing Anti-LY3084077 Antibodies | 0 participants |
| LY3084077 Cohort 5 | Number of Participants Developing Anti-LY3084077 Antibodies | 0 participants |
| LY3084077 Cohort 6 | Number of Participants Developing Anti-LY3084077 Antibodies | 0 participants |
| LY3084077 Cohort 7 | Number of Participants Developing Anti-LY3084077 Antibodies | 0 participants |
Secondary
PD: Change From Baseline in Fasting Insulin
LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.
Time frame: Baseline, Up to Day 15
Population: All randomized participants who received at least one dose of study drug and had evaluable fasting insulin data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Cohort 1 | PD: Change From Baseline in Fasting Insulin | -24.0 picomole/Liter (pmol/L) | Standard Error 8.23 |
| LY3084077 Cohort 2 | PD: Change From Baseline in Fasting Insulin | -24.6 picomole/Liter (pmol/L) | Standard Error 8.55 |
| LY3084077 Cohort 3 | PD: Change From Baseline in Fasting Insulin | -21.4 picomole/Liter (pmol/L) | Standard Error 8.41 |
| LY3084077 Cohort 4 | PD: Change From Baseline in Fasting Insulin | 4.90 picomole/Liter (pmol/L) | Standard Error 8.26 |
| LY3084077 Cohort 5 | PD: Change From Baseline in Fasting Insulin | -28.4 picomole/Liter (pmol/L) | Standard Error 9.19 |
| LY3084077 Cohort 6 | PD: Change From Baseline in Fasting Insulin | -11.9 picomole/Liter (pmol/L) | Standard Error 8.29 |
| LY3084077 Cohort 7 | PD: Change From Baseline in Fasting Insulin | -26.6 picomole/Liter (pmol/L) | Standard Error 8.44 |
Secondary
PD: Change From Baseline in Weight
Time frame: Baseline, Up to Day 15
Population: Zero participants had weight measured and therefore change from baseline in weight was not calculable across all arms.
Secondary
PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal
LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.
Time frame: Baseline, Day 2
Population: All randomized participants who received at least one dose of study drug and had evaluable incremental glucose AUC before and after a standard meal data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Cohort 1 | PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal | -1.76 millomole*hour/Liter (mmol*h/L) | Standard Error 1.16 |
| LY3084077 Cohort 2 | PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal | 0.758 millomole*hour/Liter (mmol*h/L) | Standard Error 1.18 |
| LY3084077 Cohort 3 | PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal | -0.202 millomole*hour/Liter (mmol*h/L) | Standard Error 1.14 |
| LY3084077 Cohort 4 | PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal | -0.350 millomole*hour/Liter (mmol*h/L) | Standard Error 1.15 |
| LY3084077 Cohort 5 | PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal | -2.14 millomole*hour/Liter (mmol*h/L) | Standard Error 1.13 |
| LY3084077 Cohort 6 | PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal | -1.79 millomole*hour/Liter (mmol*h/L) | Standard Error 1.13 |
| LY3084077 Cohort 7 | PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal | -1.82 millomole*hour/Liter (mmol*h/L) | Standard Error 1.15 |
Secondary
PD: Change From Baseline to Day 2 in Fasting Glucagon
LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.
Time frame: Baseline, Up to Day 2
Population: All randomized participants who received at least one dose of study drug and have evaluable fasting glucagon data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Cohort 1 | PD: Change From Baseline to Day 2 in Fasting Glucagon | 3.17 pmol/L | Standard Error 1.98 |
| LY3084077 Cohort 2 | PD: Change From Baseline to Day 2 in Fasting Glucagon | 0.940 pmol/L | Standard Error 1.96 |
| LY3084077 Cohort 3 | PD: Change From Baseline to Day 2 in Fasting Glucagon | 2.38 pmol/L | Standard Error 1.98 |
| LY3084077 Cohort 4 | PD: Change From Baseline to Day 2 in Fasting Glucagon | -0.514 pmol/L | Standard Error 1.95 |
| LY3084077 Cohort 5 | PD: Change From Baseline to Day 2 in Fasting Glucagon | 4.15 pmol/L | Standard Error 1.96 |
| LY3084077 Cohort 6 | PD: Change From Baseline to Day 2 in Fasting Glucagon | 1.01 pmol/L | Standard Error 1.99 |
| LY3084077 Cohort 7 | PD: Change From Baseline to Day 2 in Fasting Glucagon | 1.52 pmol/L | Standard Error 1.96 |
Secondary
PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal
LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.
Time frame: Baseline, Day 2
Population: All randomized participants who received at least one dose of study drug and had evaluable C-peptide AUC before and after a standard meal data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Cohort 1 | PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal | -292 picomole*hour/Liter (pmol*h/L) | Standard Error 579 |
| LY3084077 Cohort 2 | PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal | 310 picomole*hour/Liter (pmol*h/L) | Standard Error 559 |
| LY3084077 Cohort 3 | PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal | -157 picomole*hour/Liter (pmol*h/L) | Standard Error 579 |
| LY3084077 Cohort 4 | PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal | 1313 picomole*hour/Liter (pmol*h/L) | Standard Error 564 |
| LY3084077 Cohort 5 | PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal | 372 picomole*hour/Liter (pmol*h/L) | Standard Error 592 |
| LY3084077 Cohort 6 | PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal | -192 picomole*hour/Liter (pmol*h/L) | Standard Error 564 |
| LY3084077 Cohort 7 | PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal | 973 picomole*hour/Liter (pmol*h/L) | Standard Error 568 |
Secondary
Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides
Percent change=(measure at time t-measure at baseline)/measure at baseline\*100%). Least Square Means (LS means) were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.
Time frame: Baseline, Up to Day 15
Population: All randomized participants who received at least one dose of study drug and had evaluable fasting triglycerides data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Cohort 1 | Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides | -23.7 percent | Standard Deviation 12.8 |
| LY3084077 Cohort 2 | Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides | -13.7 percent | Standard Deviation 12.8 |
| LY3084077 Cohort 3 | Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides | -35.3 percent | Standard Deviation 12.6 |
| LY3084077 Cohort 4 | Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides | -30.4 percent | Standard Deviation 12.6 |
| LY3084077 Cohort 5 | Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides | -23.8 percent | Standard Deviation 13.6 |
| LY3084077 Cohort 6 | Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides | -2.50 percent | Standard Deviation 14.2 |
| LY3084077 Cohort 7 | Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides | -43.7 percent | Standard Deviation 13 |
Secondary
Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077
Time frame: Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Cohort 1 | Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077 | NA microgram*hour/milliliter (μg•hr/mL) | — |
| LY3084077 Cohort 2 | Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077 | NA microgram*hour/milliliter (μg•hr/mL) | — |
| LY3084077 Cohort 3 | Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077 | 8.74 microgram*hour/milliliter (μg•hr/mL) | Geometric Coefficient of Variation 13 |
| LY3084077 Cohort 4 | Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077 | 17.9 microgram*hour/milliliter (μg•hr/mL) | Geometric Coefficient of Variation 42 |
| LY3084077 Cohort 5 | Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077 | 61.8 microgram*hour/milliliter (μg•hr/mL) | Geometric Coefficient of Variation 34 |
| LY3084077 Cohort 6 | Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077 | 248 microgram*hour/milliliter (μg•hr/mL) | Geometric Coefficient of Variation 221 |
| LY3084077 Cohort 7 | Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077 | 249 microgram*hour/milliliter (μg•hr/mL) | Geometric Coefficient of Variation 20 |
Secondary
PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077
Time frame: Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Cohort 1 | PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077 | NA microgram/milliliter (μg/mL) | — |
| LY3084077 Cohort 2 | PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077 | NA microgram/milliliter (μg/mL) | — |
| LY3084077 Cohort 3 | PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077 | 0.0428 microgram/milliliter (μg/mL) | Geometric Coefficient of Variation 53 |
| LY3084077 Cohort 4 | PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077 | 0.0745 microgram/milliliter (μg/mL) | Geometric Coefficient of Variation 24 |
| LY3084077 Cohort 5 | PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077 | 0.188 microgram/milliliter (μg/mL) | Geometric Coefficient of Variation 78 |
| LY3084077 Cohort 6 | PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077 | 1.14 microgram/milliliter (μg/mL) | Geometric Coefficient of Variation 79 |
| LY3084077 Cohort 7 | PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077 | 1.23 microgram/milliliter (μg/mL) | Geometric Coefficient of Variation 48 |