Dyslipidemias
Conditions
Brief summary
The purpose of this two-part study is to evaluate the safety and tolerability of the study drug known as LY3202328 in healthy overweight participants in Part A, and those with dyslipidemia (abnormal blood fats) in Part B.
Interventions
DRUGLY3202328
Administered orally
DRUGPlacebo
Administered orally
DRUGAtorvastatin
Administered orally
DRUGSimvastatin
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Part A is a crossover. Part B is a parallel assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Be healthy, as determined by medical history and physical examination * Male participants must be between 18 and 70 years of age and must agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product * Female participants must be between 40 and 70 years old, and either postmenopausal or with a hysterectomy, and not pregnant and not lactating * Be on a stable diet and exercise regimen for greater than (\>) 3 months prior * Have a body mass index (BMI) of 25.0 to 35.0 (Part A) or 27.0 to 40.0 (Part B) kilograms per meter squared * Have fasting triglycerides (TG) between 150 and 499 milligrams per deciliter (mg/dL) (Part B only) * Have a fasting low-density lipoprotein cholesterol (LDL-c) between 100 and 200 mg/dL (Part B only) * Have estimated glomerular filtration rate greater than or equal to (≥) 60 milliliters per minute/1.73 meter squared with no proteinuria * Be normotensive defined as supine systolic blood pressure (BP) less than or equal to (≤) 150 millimeters of mercury (mm Hg) and diastolic BP ≤ 100 mm Hg, without the use of any antihypertensive
Exclusion criteria
* Are taking a statin, any proprotein convertase subtilisin/kexin type 9 (PCSK9) medications, or have started taking other TG lowering agents (for example, niacin, fish oils) * Are currently enrolled in a clinical trial involving an investigational product or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research, or have participated in a clinical trial involving an investigational product or non-approved use of a drug within the last 30 days or within 5 half-lives * Have an abnormal electrocardiogram or corrected QT or are on antihypertensive treatment * Have any current or prior history of significant cardiovascular disease * Show evidence of hepatitis C virus (HCV), Hepatitis B or other chronic liver disease * Have an alcohol intake that exceeds 7 units per week with no more than 3 units per day, or are unwilling to stop alcohol consumption for the duration of the study (1 unit = 12 ounces or 360 mL of beer; 5 ounces or 150 mL of wine; 1.5 ounces or 45 mL of distilled spirits), or are a regular user of known drugs of abuse * Have a history of untreated endocrine illness such as diabetes mellitus * Have been on medications or supplements for weight loss within 3 months * Have a history of active neuropsychiatric disease or on pharmacological therapy for such conditions (Part B, only) * Show evidence of human immunodeficiency virus (HIV) infection * Have been on medications that are known to inhibit cytochrome P450, family 3, subfamily A (CYP3A) or P-glycoprotein (P-gp), or regularly consume grapefruit * Have donated blood of more than 500 mL within the last month * Smoke \>10 cigarettes per day or are unwilling to follow smoking rules
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 Part A and Part B | Baseline, Up to 42 Days | Number of participants with one or more SAEs in Part A and Part B. 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: Steady State Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part B | Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose | PK is the maximum plasma concentration of LY3202328 (Cmax) at steady state in Part B. |
| PK: Area Under the Serum Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY3202328 (LY) in Part A After a Single Dose | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose | PK is the area under the serum concentration time curve from zero to Infinity (AUC\[0-∞\]) of LY3202328 in Part A after a single dose. |
| PK: Steady State Area Under the Serum Concentration-Time Curve During the Dosing Interval (AUCτ) of LY3202328 (LY) in Part B | Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose | PK is the area under the serum concentration-time curve (AUCτ) of LY3202328 at steady state during the dosing interval in Part B. |
| PK: Time to Maximum Concentration (Tmax) of LY3202328 (LY) in Part A | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose | PK is the time to maximum concentration (Tmax) of LY3202328 in Part A |
| PK: Steady State Tmax of LY3202328 (LY) in Part B | Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose | PK is the Tmax of LY3202328 at steady state in Part B. |
| Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | Predose, 24, 48, 96 Hours Postdose | Pharmacodynamics (PD) is the change from Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A. |
| PD: Change From Baseline to Last Day of Dosing in Fasting HDL-c in Part B | Predose, Days 7, 14, 21, and 28 Postdose | PD is the change from baseline to last day of dosing in fasting HDL-c in Part B. |
| PD: Change From Baseline in Fasting Total Triglycerides Part A | Predose, 24, 48, 96 Hours Postdose | PD is the change from baseline in fasting total triglycerides in Part A. |
| Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part A After a Single Dose | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose | Pharmacokinetics (PK) is the maximum plasma concentration (Cmax) of LY3202328 Part A after a single dose. |
| PD: Change From Baseline to in Fasting Total Cholesterol in Part A | Predose, 24, 28, 96 Hours Postdose | PD is the change from baseline in fasting total cholesterol in Part A. |
| PD: Change From Baseline to Last Day of Dosing in Fasting Total Cholesterol in Part B | Predose, Days 7, 14, 21, and 28 Postdose | PD is the change from baseline to last day of dosing in fasting total cholesterol in Part B. |
| PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | Predose, 24, 48, 96 Hours Postdose | PD is the change from baseline in fasting low-density lipoprotein cholesterol (LDL-c) Part A. |
| PD: Change From Baseline to Last Day of Dosing in Fasting LDL-c in Part B | Predose, Days 7, 14, 21, and 28 Postdose | PD is the change from baseline to last day of dosing in fasting LDL-c in Part B. |
| PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B | Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose | PK: Cmax of Simvastatin with/without LY3202328 (LY) Co-administration in Part B. |
| PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B | Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose | PK: Area Under Concentration Curve From Zero to Time (AUC \[0-t\]) of Simvastatin with/without LY3202328 (LY) Co-administration in Part B. AUC from time 0 to time t, where t is the time of last quantifiable plasma concentration. |
| PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B | Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose | PK: Cmax of Atorvastatin with/without LY3202328 (LY) Co-administration in Part B. |
| PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B | Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose | PK: AUC (0-t) of Atorvastatin with/without LY3202328 (LY) Co-administration in Part B. AUC from time 0 to time t, where t is the time of last quantifiable plasma concentration. |
| PD: Change From Baseline to Last Day of Dosing in Fasting Total Triglycerides in Part B | Predose, Days 7, 14, 21, and 28 Postdose | PD is the change from baseline to last day of dosing in fasting total triglycerides in Part B. |
Countries
United States
Participant flow
Pre-assignment details
Part A participants were divided into 2 cohorts. Within each cohort, participants were randomized to a treatment sequence (4 periods; up to 3 LY dose levels and at least one placebo). A 2-week washout occurred between each period. Part B participants were divided into 4 cohorts. Within each cohort, participants were randomized to LY or placebo.
Participants by arm
| Arm | Count |
|---|---|
| Part A, C1, Sequence 1 1 mg of LY3202328 (LY) was taken orally first intervention, then 10 mg of LY was taken orally second intervention, then placebo was taken orally third intervention, then 600 mg of LY was taken orally fourth intervention.
C1, Sequence 1:
(1 mg LY, 10 mg LY, Placebo, 600 mg LY) | 4 |
| Part A, C1, Sequence 2 1 mg of LY was taken orally first intervention, then placebo was taken orally second intervention, then 100 mg of LY was taken orally third intervention, then 600 mg of LY was taken orally fourth intervention.
C1, Sequence 2:
(1 mg LY, Placebo, 100 mg LY, 600 mg LY) | 3 |
| Part A, C1, Sequence 3 Placebo was taken orally first intervention, then 10 mg LY was taken orally second intervention, then, 100 mg LY was taken orally third intervention, then placebo was taken orally fourth intervention.
C1, Sequence 3: (Placebo, 10 mg LY, 100 mg LY, Placebo) | 4 |
| Part A, C2, Sequence 1 3 mg of LY was taken orally first intervention, then 30 mg of LY was taken orally second intervention, then placebo was taken orally third intervention, then 30 mg of LY fed was taken orally fourth intervention
C2, Sequence 1:
3 mg LY, 30 mg LY, Placebo, 30 mg LY Fed | 3 |
| Part A, C2, Sequence 2 3 mg of LY was taken orally first intervention, then placebo was taken orally second intervention, then 300 mg of LY was taken orally third intervention, then placebo was taken orally fourth intervention.
C2, Sequence 2:
3 mg LY, Placebo, 300 mg LY, Placebo | 3 |
| Part A, C2, Sequence 3 Placebo was taken orally first intervention, then 30 mg of LY was taken orally second intervention, then 300 mg of LY was taken orally third intervention, then 30 mg of LY fed was taken orally fourth intervention.
C2, Sequence 3:
Placebo, 30 mg LY, 300 mg LY, 30 mg LY Fed | 3 |
| Part B: SS/AS/Placebo Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29. | 8 |
| Part B: SS/AS/5 mg LY 5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29. | 8 |
| Part B: SS/AS/20 mg LY 20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29. | 8 |
| Part B: SS/AS/100 mg LY 100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29. | 8 |
| Part B: SS/AS/300 mg LY 300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29. | 8 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A Fourth Intervention | Positive Urinary Drug Screen (UDS) | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Part A Second Intervention | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A Third Intervention | Adverse Event | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A Third Intervention | Positive Urine Drug Screen (UDS) | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part B (Overall) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Part B (Overall) | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Part B (Overall) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Part B: SS/AS/20 mg LY | Total | Part B: SS/AS/300 mg LY | Part A, C1, Sequence 1 | Part A, C1, Sequence 2 | Part B: SS/AS/100 mg LY | Part A, C1, Sequence 3 | Part A, C2, Sequence 1 | Part A, C2, Sequence 2 | Part A, C2, Sequence 3 | Part B: SS/AS/Placebo | Part B: SS/AS/5 mg LY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 46.8 years STANDARD_DEVIATION 13.13 | 48.7 years STANDARD_DEVIATION 13.22 | 36.9 years STANDARD_DEVIATION 10.8 | 48.3 years STANDARD_DEVIATION 8.02 | 56.0 years STANDARD_DEVIATION 12.12 | 55.0 years STANDARD_DEVIATION 10.18 | 58.5 years STANDARD_DEVIATION 4.04 | 34.0 years STANDARD_DEVIATION 13.53 | 38.3 years STANDARD_DEVIATION 22.5 | 54.7 years STANDARD_DEVIATION 17.21 | 54.0 years STANDARD_DEVIATION 9.12 | 50.5 years STANDARD_DEVIATION 12.76 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 15 Participants | 2 Participants | 0 Participants | 0 Participants | 7 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 45 Participants | 6 Participants | 4 Participants | 3 Participants | 1 Participants | 4 Participants | 2 Participants | 3 Participants | 3 Participants | 3 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 13 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 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 | 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 47 Participants | 8 Participants | 2 Participants | 2 Participants | 8 Participants | 3 Participants | 0 Participants | 1 Participants | 2 Participants | 7 Participants | 6 Participants |
| Region of Enrollment United States | 8 Participants | 60 Participants | 8 Participants | 4 Participants | 3 Participants | 8 Participants | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 8 Participants | 8 Participants |
| Sex: Female, Male Female | 3 Participants | 21 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 39 Participants | 7 Participants | 3 Participants | 2 Participants | 4 Participants | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 4 Participants | 4 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 | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 6 | 0 / 8 | 0 / 6 | 0 / 4 | 0 / 12 | 0 / 14 | 0 / 5 |
| other Total, other adverse events | 2 / 25 | 0 / 6 | 0 / 6 | 5 / 8 | 2 / 6 | 5 / 8 | 1 / 6 | 0 / 4 | 1 / 12 | 6 / 14 | 0 / 5 |
| serious Total, serious adverse events | 0 / 25 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 6 | 0 / 8 | 0 / 6 | 0 / 4 | 0 / 12 | 2 / 14 | 0 / 5 |
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 Part A and Part B
Number of participants with one or more SAEs in Part A and Part B. 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: Baseline, Up to 42 Days
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B | 0 participants |
| Part A: 1 mg LY3202328 (LY) | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B | 0 participants |
| Part A: 3 mg LY | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B | 0 participants |
| Part A: 10 mg LY | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B | 0 participants |
| Part A: 30 mg LY | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B | 0 participants |
| Part A: 100 mg LY | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B | 0 participants |
| Part A: 300 mg LY | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B | 0 participants |
| Part A: 30 mg LY Fed | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B | 0 participants |
| Part A: 600 mg LY | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B | 0 participants |
| Part B: SS/AS/Placebo | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B | 0 participants |
| Part B: SS/AS/5 mg of LY | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B | 0 participants |
| Part B: SS/AS/20 mg of LY | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B | 0 participants |
| Part B: SS/AS/100 mg of LY | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B | 0 participants |
| Part B: SS/AS/300 mg of LY | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B | 1 participants |
Secondary
PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A
PD is the change from baseline in fasting low-density lipoprotein cholesterol (LDL-c) Part A.
Time frame: Predose, 24, 48, 96 Hours Postdose
Population: All randomized participants who received at least one dose of study drug and had evaluable LDL-c data in Part A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 24 Hours | 0.231 mmol/L | Standard Deviation 0.2513 |
| Part A: Placebo | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 96 Hours | -0.109 mmol/L | Standard Deviation 0.4147 |
| Part A: Placebo | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 48 Hours | 0.111 mmol/L | Standard Deviation 0.4026 |
| Part A: 1 mg LY3202328 (LY) | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 96 Hours | -0.358 mmol/L | Standard Deviation 0.417 |
| Part A: 1 mg LY3202328 (LY) | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 48 Hours | -0.275 mmol/L | Standard Deviation 0.3004 |
| Part A: 1 mg LY3202328 (LY) | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 24 Hours | 0.025 mmol/L | Standard Deviation 0.2205 |
| Part A: 3 mg LY | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 96 Hours | -0.061 mmol/L | Standard Deviation 0.1747 |
| Part A: 3 mg LY | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 24 Hours | 0.117 mmol/L | Standard Deviation 0.24 |
| Part A: 3 mg LY | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 48 Hours | 0.013 mmol/L | Standard Deviation 0.2093 |
| Part A: 10 mg LY | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 24 Hours | 0.020 mmol/L | Standard Deviation 0.2328 |
| Part A: 10 mg LY | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 48 Hours | -0.214 mmol/L | Standard Deviation 0.2378 |
| Part A: 10 mg LY | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 96 Hours | -0.481 mmol/L | Standard Deviation 0.3681 |
| Part A: 30 mg LY | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 48 Hours | 0.203 mmol/L | Standard Deviation 0.34 |
| Part A: 30 mg LY | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 24 Hours | 0.241 mmol/L | Standard Deviation 0.1594 |
| Part A: 30 mg LY | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 96 Hours | -0.018 mmol/L | Standard Deviation 0.3048 |
| Part A: 100 mg LY | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 48 Hours | 0.419 mmol/L | Standard Deviation 0.3293 |
| Part A: 100 mg LY | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 24 Hours | 0.471 mmol/L | Standard Deviation 0.3418 |
| Part A: 100 mg LY | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 96 Hours | -0.020 mmol/L | Standard Deviation 0.6327 |
| Part A: 300 mg LY | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 48 Hours | 0.245 mmol/L | Standard Deviation 0.3457 |
| Part A: 300 mg LY | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 24 Hours | 0.236 mmol/L | Standard Deviation 0.2429 |
| Part A: 300 mg LY | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 96 Hours | 0.075 mmol/L | Standard Deviation 0.2565 |
| Part A: 30 mg LY Fed | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 24 Hours | 0.163 mmol/L | Standard Deviation 0.1608 |
| Part A: 30 mg LY Fed | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 48 Hours | -0.001 mmol/L | Standard Deviation 0.3891 |
| Part A: 30 mg LY Fed | PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A | 96 Hours | 0.038 mmol/L | Standard Deviation 0.6305 |
Secondary
PD: Change From Baseline in Fasting Total Triglycerides Part A
PD is the change from baseline in fasting total triglycerides in Part A.
Time frame: Predose, 24, 48, 96 Hours Postdose
Population: All randomized participants who received at least one dose of study drug and had evaluable fasting triglyceride data in Part A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | PD: Change From Baseline in Fasting Total Triglycerides Part A | 96 Hours | -0.239 mmol/L | Standard Deviation 0.3227 |
| Part A: Placebo | PD: Change From Baseline in Fasting Total Triglycerides Part A | 48 Hours | -0.320 mmol/L | Standard Deviation 0.3162 |
| Part A: Placebo | PD: Change From Baseline in Fasting Total Triglycerides Part A | 24 Hours | -0.276 mmol/L | Standard Deviation 0.2043 |
| Part A: 1 mg LY3202328 (LY) | PD: Change From Baseline in Fasting Total Triglycerides Part A | 48 Hours | -0.269 mmol/L | Standard Deviation 0.226 |
| Part A: 1 mg LY3202328 (LY) | PD: Change From Baseline in Fasting Total Triglycerides Part A | 24 Hours | -0.397 mmol/L | Standard Deviation 0.2877 |
| Part A: 1 mg LY3202328 (LY) | PD: Change From Baseline in Fasting Total Triglycerides Part A | 96 Hours | -0.209 mmol/L | Standard Deviation 0.6817 |
| Part A: 3 mg LY | PD: Change From Baseline in Fasting Total Triglycerides Part A | 48 Hours | -0.115 mmol/L | Standard Deviation 0.2643 |
| Part A: 3 mg LY | PD: Change From Baseline in Fasting Total Triglycerides Part A | 24 Hours | -0.190 mmol/L | Standard Deviation 0.1491 |
| Part A: 3 mg LY | PD: Change From Baseline in Fasting Total Triglycerides Part A | 96 Hours | -0.132 mmol/L | Standard Deviation 0.2349 |
| Part A: 10 mg LY | PD: Change From Baseline in Fasting Total Triglycerides Part A | 48 Hours | -0.260 mmol/L | Standard Deviation 0.3382 |
| Part A: 10 mg LY | PD: Change From Baseline in Fasting Total Triglycerides Part A | 24 Hours | -0.386 mmol/L | Standard Deviation 0.2766 |
| Part A: 10 mg LY | PD: Change From Baseline in Fasting Total Triglycerides Part A | 96 Hours | 0.013 mmol/L | Standard Deviation 0.7179 |
| Part A: 30 mg LY | PD: Change From Baseline in Fasting Total Triglycerides Part A | 48 Hours | -0.418 mmol/L | Standard Deviation 0.329 |
| Part A: 30 mg LY | PD: Change From Baseline in Fasting Total Triglycerides Part A | 24 Hours | -0.311 mmol/L | Standard Deviation 0.2831 |
| Part A: 30 mg LY | PD: Change From Baseline in Fasting Total Triglycerides Part A | 96 Hours | -0.331 mmol/L | Standard Deviation 0.4343 |
| Part A: 100 mg LY | PD: Change From Baseline in Fasting Total Triglycerides Part A | 48 Hours | -0.766 mmol/L | Standard Deviation 0.587 |
| Part A: 100 mg LY | PD: Change From Baseline in Fasting Total Triglycerides Part A | 24 Hours | -0.523 mmol/L | Standard Deviation 0.5801 |
| Part A: 100 mg LY | PD: Change From Baseline in Fasting Total Triglycerides Part A | 96 Hours | -0.455 mmol/L | Standard Deviation 0.5144 |
| Part A: 300 mg LY | PD: Change From Baseline in Fasting Total Triglycerides Part A | 48 Hours | -0.226 mmol/L | Standard Deviation 0.3646 |
| Part A: 300 mg LY | PD: Change From Baseline in Fasting Total Triglycerides Part A | 24 Hours | -0.064 mmol/L | Standard Deviation 0.1455 |
| Part A: 300 mg LY | PD: Change From Baseline in Fasting Total Triglycerides Part A | 96 Hours | -0.326 mmol/L | Standard Deviation 0.3549 |
| Part A: 30 mg LY Fed | PD: Change From Baseline in Fasting Total Triglycerides Part A | 24 Hours | -0.302 mmol/L | Standard Deviation 0.2318 |
| Part A: 30 mg LY Fed | PD: Change From Baseline in Fasting Total Triglycerides Part A | 48 Hours | -0.198 mmol/L | Standard Deviation 0.1345 |
| Part A: 30 mg LY Fed | PD: Change From Baseline in Fasting Total Triglycerides Part A | 96 Hours | 0.158 mmol/L | Standard Deviation 0.6773 |
Secondary
PD: Change From Baseline to in Fasting Total Cholesterol in Part A
PD is the change from baseline in fasting total cholesterol in Part A.
Time frame: Predose, 24, 28, 96 Hours Postdose
Population: All randomized participants who received at least one dose of study drug and had evaluable fasting total cholesterol data in Part A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 24 Hours | 0.085 mmol/L | Standard Deviation 0.3075 |
| Part A: Placebo | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 96 Hours | -0.318 mmol/L | Standard Deviation 0.4288 |
| Part A: Placebo | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 48 Hours | -0.085 mmol/L | Standard Deviation 0.4618 |
| Part A: 1 mg LY3202328 (LY) | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 96 Hours | -0.527 mmol/L | Standard Deviation 0.3262 |
| Part A: 1 mg LY3202328 (LY) | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 48 Hours | -0.436 mmol/L | Standard Deviation 0.2608 |
| Part A: 1 mg LY3202328 (LY) | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 24 Hours | -0.186 mmol/L | Standard Deviation 0.2699 |
| Part A: 3 mg LY | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 96 Hours | -0.207 mmol/L | Standard Deviation 0.2949 |
| Part A: 3 mg LY | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 24 Hours | -0.013 mmol/L | Standard Deviation 0.285 |
| Part A: 3 mg LY | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 48 Hours | -0.030 mmol/L | Standard Deviation 0.2218 |
| Part A: 10 mg LY | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 24 Hours | -0.203 mmol/L | Standard Deviation 0.2157 |
| Part A: 10 mg LY | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 48 Hours | -0.376 mmol/L | Standard Deviation 0.2321 |
| Part A: 10 mg LY | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 96 Hours | -0.609 mmol/L | Standard Deviation 0.2635 |
| Part A: 30 mg LY | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 48 Hours | -0.013 mmol/L | Standard Deviation 0.3981 |
| Part A: 30 mg LY | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 24 Hours | 0.073 mmol/L | Standard Deviation 0.1863 |
| Part A: 30 mg LY | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 96 Hours | -0.199 mmol/L | Standard Deviation 0.4732 |
| Part A: 100 mg LY | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 48 Hours | 0.091 mmol/L | Standard Deviation 0.3654 |
| Part A: 100 mg LY | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 24 Hours | 0.285 mmol/L | Standard Deviation 0.1903 |
| Part A: 100 mg LY | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 96 Hours | -0.317 mmol/L | Standard Deviation 0.6296 |
| Part A: 300 mg LY | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 48 Hours | 0.134 mmol/L | Standard Deviation 0.5446 |
| Part A: 300 mg LY | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 24 Hours | 0.203 mmol/L | Standard Deviation 0.2421 |
| Part A: 300 mg LY | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 96 Hours | -0.155 mmol/L | Standard Deviation 0.4826 |
| Part A: 30 mg LY Fed | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 24 Hours | 0.093 mmol/L | Standard Deviation 0.156 |
| Part A: 30 mg LY Fed | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 48 Hours | -0.026 mmol/L | Standard Deviation 0.4719 |
| Part A: 30 mg LY Fed | PD: Change From Baseline to in Fasting Total Cholesterol in Part A | 96 Hours | -0.041 mmol/L | Standard Deviation 0.602 |
Secondary
PD: Change From Baseline to Last Day of Dosing in Fasting HDL-c in Part B
PD is the change from baseline to last day of dosing in fasting HDL-c in Part B.
Time frame: Predose, Days 7, 14, 21, and 28 Postdose
Population: All randomized participants who received at least one dose of study drug in Part B.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | PD: Change From Baseline to Last Day of Dosing in Fasting HDL-c in Part B | 0.008 mmol/L | Standard Deviation 0.1169 |
| Part A: 1 mg LY3202328 (LY) | PD: Change From Baseline to Last Day of Dosing in Fasting HDL-c in Part B | -0.010 mmol/L | Standard Deviation 0.1165 |
| Part A: 3 mg LY | PD: Change From Baseline to Last Day of Dosing in Fasting HDL-c in Part B | -0.101 mmol/L | Standard Deviation 0.0812 |
| Part A: 10 mg LY | PD: Change From Baseline to Last Day of Dosing in Fasting HDL-c in Part B | -0.107 mmol/L | Standard Deviation 0.1894 |
| Part A: 30 mg LY | PD: Change From Baseline to Last Day of Dosing in Fasting HDL-c in Part B | -0.101 mmol/L | Standard Deviation 0.0621 |
Secondary
PD: Change From Baseline to Last Day of Dosing in Fasting LDL-c in Part B
PD is the change from baseline to last day of dosing in fasting LDL-c in Part B.
Time frame: Predose, Days 7, 14, 21, and 28 Postdose
Population: All randomized participants who received at least one dose of study in Part B.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | PD: Change From Baseline to Last Day of Dosing in Fasting LDL-c in Part B | 0.103 mmol/L | Standard Deviation 0.4114 |
| Part A: 1 mg LY3202328 (LY) | PD: Change From Baseline to Last Day of Dosing in Fasting LDL-c in Part B | 0.184 mmol/L | Standard Deviation 0.3419 |
| Part A: 3 mg LY | PD: Change From Baseline to Last Day of Dosing in Fasting LDL-c in Part B | 0.388 mmol/L | Standard Deviation 0.4876 |
| Part A: 10 mg LY | PD: Change From Baseline to Last Day of Dosing in Fasting LDL-c in Part B | 0.227 mmol/L | Standard Deviation 0.4494 |
| Part A: 30 mg LY | PD: Change From Baseline to Last Day of Dosing in Fasting LDL-c in Part B | 0.131 mmol/L | Standard Deviation 0.4225 |
Secondary
PD: Change From Baseline to Last Day of Dosing in Fasting Total Cholesterol in Part B
PD is the change from baseline to last day of dosing in fasting total cholesterol in Part B.
Time frame: Predose, Days 7, 14, 21, and 28 Postdose
Population: All randomized participants who received at least one dose of study drug in Part B.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | PD: Change From Baseline to Last Day of Dosing in Fasting Total Cholesterol in Part B | 0.206 mmol/L | Standard Deviation 0.3615 |
| Part A: 1 mg LY3202328 (LY) | PD: Change From Baseline to Last Day of Dosing in Fasting Total Cholesterol in Part B | 0.118 mmol/L | Standard Deviation 0.384 |
| Part A: 3 mg LY | PD: Change From Baseline to Last Day of Dosing in Fasting Total Cholesterol in Part B | 0.183 mmol/L | Standard Deviation 0.4681 |
| Part A: 10 mg LY | PD: Change From Baseline to Last Day of Dosing in Fasting Total Cholesterol in Part B | 0.174 mmol/L | Standard Deviation 0.4963 |
| Part A: 30 mg LY | PD: Change From Baseline to Last Day of Dosing in Fasting Total Cholesterol in Part B | -0.190 mmol/L | Standard Deviation 0.4425 |
Secondary
PD: Change From Baseline to Last Day of Dosing in Fasting Total Triglycerides in Part B
PD is the change from baseline to last day of dosing in fasting total triglycerides in Part B.
Time frame: Predose, Days 7, 14, 21, and 28 Postdose
Population: All randomized participants who received at least one dose of study drug in Part B.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | PD: Change From Baseline to Last Day of Dosing in Fasting Total Triglycerides in Part B | 0.205 mmol/L | Standard Deviation 0.6757 |
| Part A: 1 mg LY3202328 (LY) | PD: Change From Baseline to Last Day of Dosing in Fasting Total Triglycerides in Part B | -0.131 mmol/L | Standard Deviation 0.272 |
| Part A: 3 mg LY | PD: Change From Baseline to Last Day of Dosing in Fasting Total Triglycerides in Part B | -0.231 mmol/L | Standard Deviation 0.5383 |
| Part A: 10 mg LY | PD: Change From Baseline to Last Day of Dosing in Fasting Total Triglycerides in Part B | 0.020 mmol/L | Standard Deviation 0.6281 |
| Part A: 30 mg LY | PD: Change From Baseline to Last Day of Dosing in Fasting Total Triglycerides in Part B | -0.480 mmol/L | Standard Deviation 0.5235 |
Secondary
Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A
Pharmacodynamics (PD) is the change from Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A.
Time frame: Predose, 24, 48, 96 Hours Postdose
Population: All randomized participants who received at least one dose of study drug and had evaluable fasting HDL-c data in Part A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 24 Hours | -0.003 millimole/Liter (mmol/L) | Standard Deviation 0.1155 |
| Part A: Placebo | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 96 Hours | -0.074 millimole/Liter (mmol/L) | Standard Deviation 0.1258 |
| Part A: Placebo | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 48 Hours | -0.037 millimole/Liter (mmol/L) | Standard Deviation 0.156 |
| Part A: 1 mg LY3202328 (LY) | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 96 Hours | -0.073 millimole/Liter (mmol/L) | Standard Deviation 0.1241 |
| Part A: 1 mg LY3202328 (LY) | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 48 Hours | -0.039 millimole/Liter (mmol/L) | Standard Deviation 0.0217 |
| Part A: 1 mg LY3202328 (LY) | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 24 Hours | -0.030 millimole/Liter (mmol/L) | Standard Deviation 0.0842 |
| Part A: 3 mg LY | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 96 Hours | -0.086 millimole/Liter (mmol/L) | Standard Deviation 0.0892 |
| Part A: 3 mg LY | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 24 Hours | -0.043 millimole/Liter (mmol/L) | Standard Deviation 0.0454 |
| Part A: 3 mg LY | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 48 Hours | 0.009 millimole/Liter (mmol/L) | Standard Deviation 0.1387 |
| Part A: 10 mg LY | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 24 Hours | -0.047 millimole/Liter (mmol/L) | Standard Deviation 0.074 |
| Part A: 10 mg LY | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 48 Hours | -0.043 millimole/Liter (mmol/L) | Standard Deviation 0.095 |
| Part A: 10 mg LY | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 96 Hours | -0.134 millimole/Liter (mmol/L) | Standard Deviation 0.0553 |
| Part A: 30 mg LY | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 48 Hours | -0.026 millimole/Liter (mmol/L) | Standard Deviation 0.101 |
| Part A: 30 mg LY | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 24 Hours | -0.026 millimole/Liter (mmol/L) | Standard Deviation 0.0433 |
| Part A: 30 mg LY | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 96 Hours | -0.030 millimole/Liter (mmol/L) | Standard Deviation 0.1304 |
| Part A: 100 mg LY | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 48 Hours | 0.019 millimole/Liter (mmol/L) | Standard Deviation 0.0978 |
| Part A: 100 mg LY | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 24 Hours | 0.052 millimole/Liter (mmol/L) | Standard Deviation 0.1099 |
| Part A: 100 mg LY | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 96 Hours | -0.091 millimole/Liter (mmol/L) | Standard Deviation 0.1206 |
| Part A: 300 mg LY | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 48 Hours | -0.009 millimole/Liter (mmol/L) | Standard Deviation 0.1551 |
| Part A: 300 mg LY | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 24 Hours | -0.004 millimole/Liter (mmol/L) | Standard Deviation 0.0684 |
| Part A: 300 mg LY | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 96 Hours | -0.082 millimole/Liter (mmol/L) | Standard Deviation 0.1487 |
| Part A: 30 mg LY Fed | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 24 Hours | 0.010 millimole/Liter (mmol/L) | Standard Deviation 0.0232 |
| Part A: 30 mg LY Fed | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 48 Hours | -0.052 millimole/Liter (mmol/L) | Standard Deviation 0.0755 |
| Part A: 30 mg LY Fed | Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A | 96 Hours | -0.005 millimole/Liter (mmol/L) | Standard Deviation 0.1411 |
Secondary
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part A After a Single Dose
Pharmacokinetics (PK) is the maximum plasma concentration (Cmax) of LY3202328 Part A after a single dose.
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data in Part A after a single dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part A After a Single Dose | 48.258 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 21.11 |
| Part A: 1 mg LY3202328 (LY) | Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part A After a Single Dose | 105.023 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 26.66 |
| Part A: 3 mg LY | Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part A After a Single Dose | 340.829 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 28.99 |
| Part A: 10 mg LY | Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part A After a Single Dose | 581.782 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 32.29 |
| Part A: 30 mg LY | Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part A After a Single Dose | 1600.953 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 40.01 |
| Part A: 100 mg LY | Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part A After a Single Dose | 1632.595 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 42.84 |
| Part A: 300 mg LY | Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part A After a Single Dose | 2866.855 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 51.29 |
| Part A: 30 mg LY Fed | Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part A After a Single Dose | 1105.999 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 18.47 |
Comparison: Geometric Mean Fed/Fasted Ratio of LY3202328 Cmax at 30 mg90% CI: [161.9, 259]
Secondary
PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B
PK: Area Under Concentration Curve From Zero to Time (AUC \[0-t\]) of Simvastatin with/without LY3202328 (LY) Co-administration in Part B. AUC from time 0 to time t, where t is the time of last quantifiable plasma concentration.
Time frame: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data in Part B.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B | 5 mg LY | 6.668 hr*ng/ml | Geometric Coefficient of Variation 42.96 |
| Part A: Placebo | PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B | 100 mg LY | 14.269 hr*ng/ml | Geometric Coefficient of Variation 53.78 |
| Part A: Placebo | PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B | 20 mg LY | 9.697 hr*ng/ml | Geometric Coefficient of Variation 26.81 |
| Part A: Placebo | PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B | 300 mg LY | 11.908 hr*ng/ml | Geometric Coefficient of Variation 60.19 |
| Part A: Placebo | PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B | Placebo | 9.648 hr*ng/ml | Geometric Coefficient of Variation 38.82 |
| Part A: 1 mg LY3202328 (LY) | PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B | 300 mg LY | 8.951 hr*ng/ml | Geometric Coefficient of Variation 61.65 |
| Part A: 1 mg LY3202328 (LY) | PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B | Placebo | 6.250 hr*ng/ml | Geometric Coefficient of Variation 61.54 |
| Part A: 1 mg LY3202328 (LY) | PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B | 5 mg LY | 9.287 hr*ng/ml | Geometric Coefficient of Variation 57.54 |
| Part A: 1 mg LY3202328 (LY) | PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B | 20 mg LY | 7.960 hr*ng/ml | Geometric Coefficient of Variation 32.21 |
| Part A: 1 mg LY3202328 (LY) | PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B | 100 mg LY | 10.434 hr*ng/ml | Geometric Coefficient of Variation 26.2 |
Comparison: Part B Placebo90% CI: [87.6, 274.2]
Comparison: Part B 5 mg LY90% CI: [40.7, 125.3]
Comparison: Part B 20 mg LY90% CI: [90.7, 165.1]
Comparison: Part B 100 mg LY90% CI: [89.8, 207.7]
Comparison: Part B 300 mg LY90% CI: [90.5, 194.4]
Comparison: Part B Overall90% CI: [93.2, 135.1]
Secondary
PK: Area Under the Serum Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY3202328 (LY) in Part A After a Single Dose
PK is the area under the serum concentration time curve from zero to Infinity (AUC\[0-∞\]) of LY3202328 in Part A after a single dose.
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data in Part A after a single dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | PK: Area Under the Serum Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY3202328 (LY) in Part A After a Single Dose | NA ng/mL | — |
| Part A: 1 mg LY3202328 (LY) | PK: Area Under the Serum Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY3202328 (LY) in Part A After a Single Dose | NA ng/mL | — |
| Part A: 3 mg LY | PK: Area Under the Serum Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY3202328 (LY) in Part A After a Single Dose | 7726.17 ng/mL | Geometric Coefficient of Variation 45.23 |
| Part A: 10 mg LY | PK: Area Under the Serum Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY3202328 (LY) in Part A After a Single Dose | 17018.43 ng/mL | Geometric Coefficient of Variation 62.6 |
| Part A: 30 mg LY | PK: Area Under the Serum Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY3202328 (LY) in Part A After a Single Dose | 55406.24 ng/mL | Geometric Coefficient of Variation 41.35 |
| Part A: 100 mg LY | PK: Area Under the Serum Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY3202328 (LY) in Part A After a Single Dose | 66185.70 ng/mL | Geometric Coefficient of Variation 71.44 |
| Part A: 300 mg LY | PK: Area Under the Serum Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY3202328 (LY) in Part A After a Single Dose | NA ng/mL | — |
| Part A: 30 mg LY Fed | PK: Area Under the Serum Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY3202328 (LY) in Part A After a Single Dose | 28415.22 ng/mL | Geometric Coefficient of Variation 56.67 |
Comparison: Geometric Mean Fed/Fasted Ratio of LY3202328 AUC(0-inf) at 30 mg90% CI: [144.7, 258.2]
Secondary
PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B
PK: AUC (0-t) of Atorvastatin with/without LY3202328 (LY) Co-administration in Part B. AUC from time 0 to time t, where t is the time of last quantifiable plasma concentration.
Time frame: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data in Part B.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B | 5 mg LY | 17.311 hr*ng/ml | Geometric Coefficient of Variation 6.35 |
| Part A: Placebo | PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B | 100 mg LY | 11.983 hr*ng/ml | Geometric Coefficient of Variation 38.63 |
| Part A: Placebo | PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B | 20 mg LY | 7.921 hr*ng/ml | Geometric Coefficient of Variation 57.94 |
| Part A: Placebo | PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B | 300 mg LY | 7.748 hr*ng/ml | Geometric Coefficient of Variation 50.04 |
| Part A: Placebo | PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B | Placebo | 15.874 hr*ng/ml | Geometric Coefficient of Variation 32.81 |
| Part A: 1 mg LY3202328 (LY) | PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B | 300 mg LY | 9.111 hr*ng/ml | Geometric Coefficient of Variation 36.39 |
| Part A: 1 mg LY3202328 (LY) | PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B | Placebo | 16.518 hr*ng/ml | Geometric Coefficient of Variation 33.88 |
| Part A: 1 mg LY3202328 (LY) | PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B | 5 mg LY | 14.913 hr*ng/ml | Geometric Coefficient of Variation 48.97 |
| Part A: 1 mg LY3202328 (LY) | PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B | 20 mg LY | 7.952 hr*ng/ml | Geometric Coefficient of Variation 63.04 |
| Part A: 1 mg LY3202328 (LY) | PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B | 100 mg LY | 13.207 hr*ng/ml | Geometric Coefficient of Variation 61.25 |
Comparison: Part B Placebo90% CI: [90.2, 102.1]
Comparison: Part B 5 mg LY90% CI: [59.8, 137.6]
Comparison: Part B 20 mg LY90% CI: [75.9, 131.5]
Comparison: Part B 100 mg LY90% CI: [67.5, 122.7]
Comparison: Part B 300 mg LY90% CI: [42, 180.5]
Comparison: Part B Overall90% CI: [81.8, 106.9]
Secondary
PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B
PK: Cmax of Atorvastatin with/without LY3202328 (LY) Co-administration in Part B.
Time frame: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data in Part B.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B | 5 mg LY | 2.840 ng/mL | Geometric Coefficient of Variation 27.96 |
| Part A: Placebo | PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B | 100 mg LY | 2.511 ng/mL | Geometric Coefficient of Variation 32.17 |
| Part A: Placebo | PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B | 20 mg LY | 1.238 ng/mL | Geometric Coefficient of Variation 38.05 |
| Part A: Placebo | PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B | 300 mg LY | 1.489 ng/mL | Geometric Coefficient of Variation 42.11 |
| Part A: Placebo | PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B | Placebo | 3.479 ng/mL | Geometric Coefficient of Variation 20.58 |
| Part A: 1 mg LY3202328 (LY) | PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B | 300 mg LY | 1.376 ng/mL | Geometric Coefficient of Variation 59.68 |
| Part A: 1 mg LY3202328 (LY) | PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B | Placebo | 3.575 ng/mL | Geometric Coefficient of Variation 30.44 |
| Part A: 1 mg LY3202328 (LY) | PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B | 5 mg LY | 3.621 ng/mL | Geometric Coefficient of Variation 82.05 |
| Part A: 1 mg LY3202328 (LY) | PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B | 20 mg LY | 1.286 ng/mL | Geometric Coefficient of Variation 45.27 |
| Part A: 1 mg LY3202328 (LY) | PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B | 100 mg LY | 3.105 ng/mL | Geometric Coefficient of Variation 51.95 |
Comparison: Part B Placebo90% CI: [80.4, 117.8]
90% CI: [31.3, 106]
Comparison: Part B 20 mg LY90% CI: [66.8, 138.7]
Comparison: Part B 100 mg LY90% CI: [45.8, 142.7]
Comparison: Part B 300 mg LY90% CI: [40.2, 291.2]
Comparison: Part B Overall90% CI: [67.4, 114.7]
Secondary
PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B
PK: Cmax of Simvastatin with/without LY3202328 (LY) Co-administration in Part B.
Time frame: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data in Part B.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B | 5 mg LY | 2.388 ng/ml | Geometric Coefficient of Variation 58.17 |
| Part A: Placebo | PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B | 100 mg LY | 4.634 ng/ml | Geometric Coefficient of Variation 55.59 |
| Part A: Placebo | PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B | 20 mg LY | 3.576 ng/ml | Geometric Coefficient of Variation 19.35 |
| Part A: Placebo | PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B | 300 mg LY | 4.221 ng/ml | Geometric Coefficient of Variation 58.78 |
| Part A: Placebo | PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B | Placebo | 2.906 ng/ml | Geometric Coefficient of Variation 18.72 |
| Part A: 1 mg LY3202328 (LY) | PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B | 300 mg LY | 1.979 ng/ml | Geometric Coefficient of Variation 55.84 |
| Part A: 1 mg LY3202328 (LY) | PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B | Placebo | 2.061 ng/ml | Geometric Coefficient of Variation 71.24 |
| Part A: 1 mg LY3202328 (LY) | PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B | 5 mg LY | 3.374 ng/ml | Geometric Coefficient of Variation 52.99 |
| Part A: 1 mg LY3202328 (LY) | PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B | 20 mg LY | 3.274 ng/ml | Geometric Coefficient of Variation 26.87 |
| Part A: 1 mg LY3202328 (LY) | PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B | 100 mg LY | 4.303 ng/ml | Geometric Coefficient of Variation 25.45 |
Comparison: Part B Placebo90% CI: [67.9, 293]
Comparison: Part B 5 mg LY90% CI: [31.9, 157.1]
Comparison: Part B 20 mg LY90% CI: [99.8, 119.5]
Comparison: Part B 100 mg LY90% CI: [68.1, 170.4]
Comparison: Part B 300 mg LY90% CI: [200.3, 227.1]
Comparison: Part B Overall90% CI: [91.2, 146.2]
Secondary
PK: Steady State Area Under the Serum Concentration-Time Curve During the Dosing Interval (AUCτ) of LY3202328 (LY) in Part B
PK is the area under the serum concentration-time curve (AUCτ) of LY3202328 at steady state during the dosing interval in Part B.
Time frame: Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
Population: All randomized participants who received at least one dose of study drug in Part B.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | PK: Steady State Area Under the Serum Concentration-Time Curve During the Dosing Interval (AUCτ) of LY3202328 (LY) in Part B | 7587.24 hour*nanogram/milliliter(hr*ng/ml) | Geometric Coefficient of Variation 38.612 |
| Part A: 1 mg LY3202328 (LY) | PK: Steady State Area Under the Serum Concentration-Time Curve During the Dosing Interval (AUCτ) of LY3202328 (LY) in Part B | 13362.44 hour*nanogram/milliliter(hr*ng/ml) | Geometric Coefficient of Variation 44.984 |
| Part A: 3 mg LY | PK: Steady State Area Under the Serum Concentration-Time Curve During the Dosing Interval (AUCτ) of LY3202328 (LY) in Part B | 67499.80 hour*nanogram/milliliter(hr*ng/ml) | Geometric Coefficient of Variation 37.465 |
| Part A: 10 mg LY | PK: Steady State Area Under the Serum Concentration-Time Curve During the Dosing Interval (AUCτ) of LY3202328 (LY) in Part B | 50774.85 hour*nanogram/milliliter(hr*ng/ml) | Geometric Coefficient of Variation 43.861 |
Secondary
PK: Steady State Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part B
PK is the maximum plasma concentration of LY3202328 (Cmax) at steady state in Part B.
Time frame: Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
Population: All randomized participants who received at least one dose of study drug in Part B.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | PK: Steady State Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part B | 445.858 ng/ml | Geometric Coefficient of Variation 32.78 |
| Part A: 1 mg LY3202328 (LY) | PK: Steady State Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part B | 882.125 ng/ml | Geometric Coefficient of Variation 32.81 |
| Part A: 3 mg LY | PK: Steady State Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part B | 3687.167 ng/ml | Geometric Coefficient of Variation 34.83 |
| Part A: 10 mg LY | PK: Steady State Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part B | 3209.396 ng/ml | Geometric Coefficient of Variation 37.31 |
Secondary
PK: Steady State Tmax of LY3202328 (LY) in Part B
PK is the Tmax of LY3202328 at steady state in Part B.
Time frame: Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
Population: All randomized participants who received at least one dose of study drug in Part B.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | PK: Steady State Tmax of LY3202328 (LY) in Part B | 2.00 hr |
| Part A: 1 mg LY3202328 (LY) | PK: Steady State Tmax of LY3202328 (LY) in Part B | 4.20 hr |
| Part A: 3 mg LY | PK: Steady State Tmax of LY3202328 (LY) in Part B | 3.00 hr |
| Part A: 10 mg LY | PK: Steady State Tmax of LY3202328 (LY) in Part B | 3.04 hr |
Secondary
PK: Time to Maximum Concentration (Tmax) of LY3202328 (LY) in Part A
PK is the time to maximum concentration (Tmax) of LY3202328 in Part A
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data in Part A.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | PK: Time to Maximum Concentration (Tmax) of LY3202328 (LY) in Part A | 2.02 hour (hr) |
| Part A: 1 mg LY3202328 (LY) | PK: Time to Maximum Concentration (Tmax) of LY3202328 (LY) in Part A | 3.52 hour (hr) |
| Part A: 3 mg LY | PK: Time to Maximum Concentration (Tmax) of LY3202328 (LY) in Part A | 4.0 hour (hr) |
| Part A: 10 mg LY | PK: Time to Maximum Concentration (Tmax) of LY3202328 (LY) in Part A | 4.00 hour (hr) |
| Part A: 30 mg LY | PK: Time to Maximum Concentration (Tmax) of LY3202328 (LY) in Part A | 6.00 hour (hr) |
| Part A: 100 mg LY | PK: Time to Maximum Concentration (Tmax) of LY3202328 (LY) in Part A | 4.02 hour (hr) |
| Part A: 300 mg LY | PK: Time to Maximum Concentration (Tmax) of LY3202328 (LY) in Part A | 4.00 hour (hr) |
| Part A: 30 mg LY Fed | PK: Time to Maximum Concentration (Tmax) of LY3202328 (LY) in Part A | 5.00 hour (hr) |