A Study to Evaluate LY3202328 in Overweight Healthy Parti... | NCT02714569 | Trialant
NCT02714569
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
May 25, 2021Actual
Enrollment
60Actual
Phase
Phase 1
Conditions
Dyslipidemias
Interventions
LY3202328
Placebo
Atorvastatin
Simvastatin
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT02714569
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
16417
Secondary IDs
ID
Type
Description
Link
I8Q-MC-GSEA
Other Identifier
Eli Lilly and Company
Brief Title
A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Oral Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LY3202328
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
May 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 2016
Primary Completion Date
Feb 15, 2017Actual
Completion Date
Feb 15, 2017Actual
First Submitted Date
Mar 16, 2016
First Submission Date that Met QC Criteria
Mar 16, 2016
First Posted Date
Mar 21, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 22, 2021
Results First Submitted that Met QC Criteria
May 3, 2021
Results First Posted Date
May 25, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 3, 2021
Last Update Posted Date
May 25, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Dyslipidemias
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
60Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A: LY3202328 (LY)
Experimental
Single ascending doses of 1 milligram (mg), 3 mg, 10 mg, 30 mg, 100 mg, 300mg, 600 mg LY3202328 orally while fasting, or 30 mg LY3202328 orally while fed in 4 periods.
Drug: LY3202328
Part A: Placebo
Placebo Comparator
A single ascending dose of placebo orally, in 1 period while fasting, and up to one period while fed.
Drug: Placebo
Part B: LY3202328 (LY)
Experimental
A multiple ascending dose of 5 mg, 20 mg, 100 mg, and 300 mg LY3202328 at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (atorvastatin or simvastatin) one week prior to treatment and on Day 29.
Drug: LY3202328
Drug: Atorvastatin
Drug: Simvastatin
Part B: Placebo
Placebo Comparator
A multiple ascending dose of placebo at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (atorvastatin or simvastatin) one week prior to treatment and on Day 29.
Drug: Placebo
Drug: Atorvastatin
Drug: Simvastatin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY3202328
Drug
Administered orally
Part A: LY3202328 (LY)
Part B: LY3202328 (LY)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
Baseline, Up to 42 Days
Secondary Outcomes
Measure
Description
Time Frame
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.
PK: Steady State Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part B
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
70 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Clinical Pharmacology of Miami, Inc.
Miami
Florida
33014
United States
PRA Health Sciences
References Module
Citations
Not provided
See Also Links
Label
URL
A Study of LY3202328 in Overweight Healthy Participants and in Participants With Dyslipidemia
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.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: Cohort 1(C1), Sequence 1
1 milligram (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.
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.
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.
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.
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.
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.
Part B: C3 (Simvastatin [SS]/Atorvastatin[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.
FG007
Part B: C4 (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.
FG008
Part B: C5 (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.
FG009
Part B: C6 (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.
FG010
Part B: C3-C6 (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.
Periods
Title
Milestones
Reasons Not Completed
Part A First Intervention
Type
Comment
Milestone Data
STARTED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG004
Received at Least One Dose of Study Drug
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
COMPLETED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part A Second Intervention
Type
Comment
Milestone Data
STARTED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG003
Part A Third Intervention
Type
Comment
Milestone Data
STARTED
FG0003 subjects
FG0012 subjects
FG0023 subjects
FG003
Part A Fourth Intervention
Type
Comment
Milestone Data
STARTED
FG0004 subjectsAn additional participant replaced a discontinued participant.
FG0012 subjects
FG0023 subjectsAn additional participant replaced a discontinued participant.
FG003
Part B (Overall)
Type
Comment
Milestone Data
STARTED
FG0000 subjectsPart A participants completed period 4 and were not in part B.
FG0010 subjectsPart A participants completed period 4 and were not in part B.
FG0020 subjectsPart A participants completed period 4 and were not in part B.
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
All participants who received at least one dose of study drug in Part A and Part B.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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)
BG001
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
All participants who received at least one dose of study drug.
Posted
Number
participants
Baseline, Up to 42 Days
ID
Title
Description
OG000
Part A: Placebo
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
OG001
Part A: 1 mg LY3202328 (LY)
Adverse Events Module
Frequency Threshold
5
Time Frame
From Baseline to End of Study (Up to 10 Weeks)
Description
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Participants were randomly assigned to placebo instead of LY in one of the first three periods in Part A. 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 in Part B.
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.
Predose, 24, 48, 96 Hours Postdose
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.
Predose, Days 7, 14, 21, and 28 Postdose
PD: Change From Baseline in Fasting Total Triglycerides Part A
PD is the change from baseline in fasting total triglycerides in Part A.
Predose, 24, 48, 96 Hours Postdose
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.
Predose, Days 7, 14, 21, and 28 Postdose
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.
Predose, 24, 28, 96 Hours Postdose
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.
Predose, Days 7, 14, 21, and 28 Postdose
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.
Predose, 24, 48, 96 Hours Postdose
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.
Predose, Days 7, 14, 21, and 28 Postdose
PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B
PK: Cmax of Simvastatin with/without LY3202328 (LY) Co-administration 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) 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.
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) in Part B
PK: Cmax of Atorvastatin with/without LY3202328 (LY) Co-administration 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) 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.
Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
Lenexa
Kansas
06219
United States
PRA Health Sciences
Marlton
New Jersey
08053
United States
PRA Health Sciences
Salt Lake City
Utah
84106
United States
3 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG004
3 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
3 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
3 subjects
FG0043 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Received at Least One Dose of Study Drug
FG0003 subjects
FG0012 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG0003 subjects
FG0012 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
3 subjects
FG0043 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Received at Least One Dose of Study Drug
FG0003 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0043 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG0003 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0043 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Type
Comment
Reasons
Positive Urine Drug Screen (UDS)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
2 subjects
FG0043 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Received at Least One Dose of Study Drug
FG0003 subjects
FG0012 subjects
FG0023 subjects
FG0032 subjects
FG0043 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG0003 subjects
FG0012 subjects
FG0023 subjects
FG0032 subjects
FG0043 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Type
Comment
Reasons
Positive Urinary Drug Screen (UDS)
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
Part A participants completed period 4 and were not in part B.
FG0040 subjectsPart A participants completed period 4 and were not in part B.
FG0050 subjectsPart A participants completed period 4 and were not in part B.
FG0068 subjectsPart B participants randomized to receive 5 mg of LY3202328 + atorvastatin/simvastatin.
FG0078 subjectsPart B participants randomized to receive 20 mg of LY3202328 + atorvastatin/simvastatin.
FG0088 subjectsPart B participants randomized to receive 100 mg of LY3202328 + atorvastatin/simvastatin.
FG0098 subjectsPart B participants randomized to receive 300 mg of LY3202328 + atorvastatin/simvastatin.
FG0108 subjectsPart B participants randomized to receive placebo instead of LY3202328 + atorvastatin/simvastatin.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0067 subjects
FG0077 subjects
FG0088 subjects
FG0096 subjects
FG0108 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
FG0092 subjects
FG0100 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
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)
BG002
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.
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
BG004
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
BG005
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
BG006
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.
BG007
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.
BG008
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.
BG009
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.
BG010
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.
BG011
Total
Total of all reporting groups
4
BG0013
BG0024
BG0033
BG0043
BG0053
BG0068
BG0078
BG0088
BG0098
BG0108
BG01160
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00048.3± 8.02
BG00156.0± 12.12
BG00258.5± 4.04
BG00334.0± 13.53
BG00438.3± 22.50
BG00554.7± 17.21
BG00654.0± 9.12
BG00750.5± 12.76
BG00846.8± 13.13
BG00955.0± 10.18
BG01036.9± 10.80
BG01148.7± 13.22
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG0022
BG0030
BG0040
BG0051
BG0064
BG0074
BG0083
BG0094
BG0101
BG01121
Male
BG0003
BG0012
BG0022
BG0033
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0031
BG0040
BG0050
BG0065
BG0070
BG0080
BG0097
BG0102
BG01115
Not Hispanic or Latino
BG0004
BG0013
BG0024
BG0032
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0002
BG0011
BG0021
BG0033
BG004
White
BG0002
BG0012
BG0023
BG0030
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
United States
Title
Measurements
BG0004
BG0013
BG0024
BG0033
BG0043
BG0053
BG0068
BG0078
BG0088
BG0098
BG0108
BG01160
1 mg of LY was taken orally in one of four periods.
OG002
Part A: 3 mg LY
3 mg of LY was taken orally in one of four periods.
OG003
Part A: 10 mg LY
10 mg of LY was taken orally in one of four periods.
OG004
Part A: 30 mg LY
30 mg of LY was taken orally in one of four periods.
OG005
Part A: 100 mg LY
100 mg of LY was taken orally in one of four periods.
OG006
Part A: 300 mg LY
300 mg of LY was taken orally in one of four periods.
OG007
Part A: 30 mg LY Fed
30 mg (fed) of LY was taken orally in one of four periods.
OG008
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
OG009
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.
OG010
Part B: SS/AS/5 mg of 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.
OG011
Part B: SS/AS/20 mg of 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.
OG012
Part B: SS/AS/100 mg of 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.
OG013
Part B: SS/AS/300 mg of 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.
Units
Counts
Participants
OG00020
OG0017
OG0026
OG0038
OG0046
OG0057
OG0066
OG0077
OG0087
OG0098
OG0108
OG0118
OG0128
OG0138
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0131
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.
All randomized participants who received at least one dose of study drug and had evaluable PK data in Part A after a single dose.
5 mg of LY 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.
OG001
Part B: 20 mg LY
20 mg of LY 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.
OG002
Part B: 100 mg LY
100 mg of LY 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.
OG003
Part B: 300 mg LY
300 mg of LY 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.
Units
Counts
Participants
OG0007
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG000445.858± 32.78
OG001882.125± 32.81
OG0023687.167± 34.83
OG003
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.
All randomized participants who received at least one dose of study drug and had evaluable PK data in Part A after a single dose.
5 mg of LY 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.
OG001
Part B: 20 mg LY
20 mg of LY 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.
OG002
Part B: 100 mg LY
100 mg of LY 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.
OG003
Part B: 300 mg LY
300 mg of LY 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.
Units
Counts
Participants
OG0007
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0007587.24± 38.612
OG00113362.44± 44.984
OG00267499.80± 37.465
OG003
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
All randomized participants who received at least one dose of study drug and had evaluable PK data in Part A.
5 mg of LY 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.
OG001
Part B: 20 mg LY
20 mg of LY 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.
OG002
Part B: 100 mg LY
100 mg of LY 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.
OG003
Part B: 300 mg LY
300 mg of LY 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.
Units
Counts
Participants
OG0007
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.00(2.0 to 6.0)
OG0014.20(4.0 to 6.0)
OG0023.00(2.0 to 4.0)
OG003
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.
All randomized participants who received at least one dose of study drug and had evaluable fasting HDL-c data in Part A.
Posted
Mean
Standard Deviation
millimole/Liter (mmol/L)
Predose, 24, 48, 96 Hours Postdose
ID
Title
Description
OG000
Part A: Placebo
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
OG001
Part A: 1 mg LY
1 mg of LY was taken orally in one of four periods.
OG002
Part A: 3 mg LY
3 mg of LY was taken orally in one of four periods.
OG003
Part A: 10 mg LY
10 mg of LY was taken orally in one of four periods.
OG004
Part A: 30 mg LY
30 mg of LY was taken orally in one of four periods.
OG005
Part A: 100 mg LY
100 mg of LY was taken orally in one of four periods.
OG006
Part A: 300 mg LY
300 mg of LY was taken orally in one of four periods.
OG007
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods..
Units
Counts
Participants
OG00019
OG0016
OG0026
OG003
Title
Denominators
Categories
24 Hours
Title
Measurements
OG000-0.003± 0.1155
OG001-0.030± 0.0842
OG002-0.043± 0.0454
OG003
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.
All randomized participants who received at least one dose of study drug in Part B.
Posted
Mean
Standard Deviation
mmol/L
Predose, Days 7, 14, 21, and 28 Postdose
ID
Title
Description
OG000
Part B: Placebo
A multiple ascending dose 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.
OG001
Part B: 5 mg LY
5 mg of LY 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.
OG002
Part B: 20 mg LY
20 mg of LY 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.
OG003
Part B: 100 mg LY
100 mg of LY 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.
OG004
Part B: 300 mg LY
300 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) week prior to treatment and on Day 29.
Units
Counts
Participants
OG0008
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.008± 0.1169
OG001-0.010± 0.1165
OG002-0.101± 0.0812
OG003
Secondary
PD: Change From Baseline in Fasting Total Triglycerides Part A
PD is the change from baseline in fasting total triglycerides in Part A.
All randomized participants who received at least one dose of study drug and had evaluable fasting triglyceride data in Part A.
Posted
Mean
Standard Deviation
mmol/L
Predose, 24, 48, 96 Hours Postdose
ID
Title
Description
OG000
Part A: Placebo
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
OG001
Part A: 1 mg LY
1 mg of LY was taken orally in one of four periods.
OG002
Part A: 3 mg LY
3 mg of LY was taken orally in one of four periods.
OG003
Part A: 10 mg LY
10 mg of LY was taken orally in one of four periods.
OG004
Part A: 30 mg LY
30 mg of LY was taken orally in one of four periods.
OG005
Part A: 100 mg LY
100 mg of LY was taken orally in one of four periods.
OG006
Part A: 300 mg LY
300 mg of LY was taken orally in one of four periods.
OG007
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Units
Counts
Participants
OG00019
OG0016
OG0026
OG003
Title
Denominators
Categories
24 Hours
Title
Measurements
OG000-0.276± 0.2043
OG001-0.397± 0.2877
OG002-0.190± 0.1491
OG003
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.
All randomized participants who received at least one dose of study drug in Part B.
Posted
Mean
Standard Deviation
mmol/L
Predose, Days 7, 14, 21, and 28 Postdose
ID
Title
Description
OG000
Part B: Placebo
A multiple ascending dose 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.
OG001
Part B: 5 mg LY
5 mg of LY 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.
OG002
Part B: 20 mg LY
20 mg of LY 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.
OG003
Part B: 100 mg LY
100 mg of LY 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.
OG004
Part B: 300 mg LY
300 mg of LY 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.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.205± 0.6757
OG001-0.131± 0.2720
OG002-0.231± 0.5383
OG003
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.
All randomized participants who received at least one dose of study drug and had evaluable fasting total cholesterol data in Part A.
Posted
Mean
Standard Deviation
mmol/L
Predose, 24, 28, 96 Hours Postdose
ID
Title
Description
OG000
Part A: Placebo
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
OG001
Part A: 1 mg LY
1 mg of LY was taken orally in one of four periods.
OG002
Part A: 3 mg LY
3 mg of LY was taken orally in one of four periods.
OG003
Part A: 10 mg LY
10 mg of LY was taken orally in one of four periods.
OG004
Part A: 30 mg LY
30 mg of LY was taken orally in one of four periods.
OG005
Part A: 100 mg LY
100 mg of LY was taken orally in one of four periods.
OG006
Part A: 300 mg LY
300 mg of LY was taken orally in one of four periods.
OG007
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Units
Counts
Participants
OG00019
OG0016
OG0026
OG003
Title
Denominators
Categories
24 Hours
Title
Measurements
OG0000.085± 0.3075
OG001-0.186± 0.2699
OG002-0.013± 0.2850
OG003
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.
All randomized participants who received at least one dose of study drug in Part B.
Posted
Mean
Standard Deviation
mmol/L
Predose, Days 7, 14, 21, and 28 Postdose
ID
Title
Description
OG000
Part B: Placebo
A multiple ascending dose of placebo 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.
OG001
Part B: 5 mg LY
5 mg of LY 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.
OG002
Part B: 20 mg LY
20 mg of LY 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.
OG003
Part B: 100 mg LY
100 mg of LY 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.
OG004
Part B: 300 mg LY
300 mg of LY 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.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.206± 0.3615
OG0010.118± 0.3840
OG0020.183± 0.4681
OG003
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.
All randomized participants who received at least one dose of study drug and had evaluable LDL-c data in Part A.
Posted
Mean
Standard Deviation
mmol/L
Predose, 24, 48, 96 Hours Postdose
ID
Title
Description
OG000
Part A: Placebo
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
OG001
Part A: 1 mg LY
1 mg of LY was taken orally in one of four periods.
OG002
Part A: 3 mg LY
3 mg of LY was taken orally in one of four periods.
OG003
Part A: 10 mg LY
10 mg of LY was taken orally in one of four periods..
OG004
Part A: 30 mg LY
30 mg of LY was taken orally in one of four periods.
OG005
Part A: 100 mg LY
100 mg of LY was taken orally in one of four periods.
OG006
Part A: 300 mg LY
300 mg of LY was taken orally in one of four periods.
OG007
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Units
Counts
Participants
OG00019
OG0016
OG0026
OG003
Title
Denominators
Categories
24 Hours
Title
Measurements
OG0000.231± 0.2513
OG0010.025± 0.2205
OG0020.117± 0.2400
OG003
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.
All randomized participants who received at least one dose of study in Part B.
Posted
Mean
Standard Deviation
mmol/L
Predose, Days 7, 14, 21, and 28 Postdose
ID
Title
Description
OG000
Part B: 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.
OG001
Part B: 5 mg LY
5 mg of LY 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.
OG002
Part B: 20 mg LY
20 mg of LY 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.
OG003
Part B: 100 mg LY
100 mg of LY 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.
OG004
Part B: 300 mg LY
5 mg of LY 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.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.103± 0.4114
OG0010.184± 0.3419
OG0020.388± 0.4876
OG003
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.
All randomized participants who received at least one dose of study drug and had evaluable PK data in Part B.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/ml
Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
ID
Title
Description
OG000
Simvastatin With LY (Test)
A single simvastatin test dose was taken fasted a week prior to LY treatment initiation, and on Day 29 after initiation of LY daily dosing (coadministered with LY).
OG001
Simvastatin Alone (Reference)
A single simvastatin reference dose was taken fasted a week prior to LY treatment initiation, and on Day 29 after initiation of LY daily dosing without LY.
Units
Counts
Participants
OG0008
OG0018
Title
Denominators
Categories
Placebo
Title
Measurements
OG0002.906± 18.72
OG0012.061± 71.24
5 mg LY
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Part B Placebo
Geometric Least Square Means Ratio (%)
141.0
2-Sided
90
67.9
293.0
Other
Ratio estimate without hypothesis testing
OG000
OG001
Part B 5 mg LY
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.
All randomized participants who received at least one dose of study drug and had evaluable PK data in Part B.
Posted
Geometric Mean
Geometric Coefficient of Variation
hr*ng/ml
Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
ID
Title
Description
OG000
Simvastatin With LY (Test)
A single simvastatin test dose was taken fasted a week prior to LY treatment initiation, and on Day 29 after initiation of LY daily dosing (coadministered with LY).
OG001
Simvastatin Alone (Reference)
A single simvastatin reference dose was taken fasted a week prior to LY treatment initiation, and on Day 29 after initiation of LY daily dosing without LY.
Units
Counts
Participants
OG0008
OG0018
Title
Denominators
Categories
Placebo
Title
Measurements
OG0009.648± 38.82
OG0016.250± 61.54
5 mg LY
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Part B Placebo
Geometric Least Squares Mean Ratio (%)
155
2-Sided
90
87.6
274.2
Other
Ratio estimate without hypothesis testing
OG000
OG001
Part B 5 mg LY
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.
All randomized participants who received at least one dose of study drug and had evaluable PK data in Part B.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
ID
Title
Description
OG000
Atorvastatin With LY (Test)
A single atorvastatin test dose was taken fasted a week prior to LY treatment initiation, and on Day 29 after initiation of LY daily dosing (coadministered with LY).
OG001
Atorvastatin Alone (Reference)
A single atorvastatin reference dose was taken fasted a week prior to LY treatment initiation, and on Day 29 after initiation of LY daily dosing without LY.
Units
Counts
Participants
OG0008
OG0018
Title
Denominators
Categories
Placebo
Title
Measurements
OG0003.479± 20.58
OG0013.575± 30.44
5 mg LY
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Part B Placebo
Geometric Least Squares Mean Ratio (%)
97.3
2-Sided
90
80.4
117.8
Other
Ratio estimate without hypothesis testing
OG000
OG001
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.
All randomized participants who received at least one dose of study drug and had evaluable PK data in Part B.
Posted
Geometric Mean
Geometric Coefficient of Variation
hr*ng/ml
Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
ID
Title
Description
OG000
Atorvastatin With LY (Test)
A single atorvastatin test dose was taken fasted a week prior to LY treatment initiation, and on Day 29 after initiation of LY daily dosing (coadministered with LY).
OG001
Atorvastatin Alone (Reference)
A single atorvastatin reference dose was taken fasted a week prior to LY treatment initiation, and on Day 29 after initiation of LY daily dosing without LY.
Units
Counts
Participants
OG0008
OG0018
Title
Denominators
Categories
Placebo
Title
Measurements
OG00015.874± 32.81
OG00116.518± 33.88
5 mg LY
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Part B Placebo
Geometric Least Square Means Ratio (%)
96.0
2-Sided
90
90.2
102.1
Other
Ratio estimate without hypothesis testing
OG000
OG001
Part B 5 mg LY
0
25
0
25
2
25
EG001
1 mg LY3202328 (LY)
1 mg of LY was taken orally in one of four periods in Part A.
0
6
0
6
0
6
EG002
3 mg LY
3 mg of LY was taken orally in one of four periods in Part A.
0
6
0
6
0
6
EG003
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 in Part B.
0
8
0
8
5
8
EG004
10 mg LY
10 mg of LY was taken orally in one of four periods in Part A.
0
6
0
6
2
6
EG005
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 in Part B.
0
8
0
8
5
8
EG006
30 mg LY
30 mg of LY was taken orally in one of four periods in Part A.
0
6
0
6
1
6
EG007
30 mg LY Fed
30 mg of LY (fed) was taken orally in one of four periods in Part A.
0
4
0
4
0
4
EG008
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 in Part B.
0
12
0
12
1
12
EG009
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 in Part B.
0
14
2
14
6
14
EG010
600 mg of LY
600 mg of LY was taken orally in one of four periods in Part A.
0
5
0
5
0
5
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0092 events1 affected14 at risk
EG0100 events0 affected5 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0091 events1 affected14 at risk
EG0100 events0 affected5 at risk
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0091 events1 affected14 at risk
EG0100 events0 affected5 at risk
Diarrhea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected14 at risk
EG0100 events0 affected5 at risk
Dysphagia
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0091 events1 affected14 at risk
EG0100 events0 affected5 at risk
Epigastric discomfort
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0091 events1 affected14 at risk
EG0100 events0 affected5 at risk
Flatulence
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected14 at risk
EG0100 events0 affected5 at risk
Nausea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0091 events1 affected14 at risk
EG0100 events0 affected5 at risk
Stomach pain
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0091 events1 affected14 at risk
EG0100 events0 affected5 at risk
Fatigue
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected14 at risk
EG0100 events0 affected5 at risk
Kidney infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected14 at risk
EG0100 events0 affected5 at risk
Alanine aminotransferase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0093 events1 affected14 at risk
EG0100 events0 affected5 at risk
Alt increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0091 events1 affected14 at risk
EG0100 events0 affected5 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0092 events1 affected14 at risk
EG0100 events0 affected5 at risk
Pr interval prolonged
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected14 at risk
EG0100 events0 affected5 at risk
Hypertriglyceridemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0091 events1 affected14 at risk
EG0100 events0 affected5 at risk
Pain in hip
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected14 at risk
EG0100 events0 affected5 at risk
Stiff neck
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected14 at risk
EG0100 events0 affected5 at risk
Dizziness
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected12 at risk
EG0091 events1 affected14 at risk
EG0100 events0 affected5 at risk
Headache
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0032 events2 affected8 at risk
EG0041 events1 affected6 at risk
EG0052 events2 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected12 at risk
EG0092 events2 affected14 at risk
EG0100 events0 affected5 at risk
Tension headache
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected14 at risk
EG0100 events0 affected5 at risk
Anxiety
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0091 events1 affected14 at risk
EG0100 events0 affected5 at risk
Dysuria
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected14 at risk
EG0100 events0 affected5 at risk
Dry cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0091 events1 affected14 at risk
EG0100 events0 affected5 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0091 events1 affected14 at risk
EG0100 events0 affected5 at risk
Dermatographic urticaria
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0091 events1 affected14 at risk
EG0100 events0 affected5 at risk
Papule
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected14 at risk
EG0100 events0 affected5 at risk
Flushed
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected14 at risk
EG0100 events0 affected5 at risk
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
D006538
Heptanoic Acids
D005227
Fatty Acids
D008055
Lipids
D008148
Lovastatin
D009281
Naphthalenes
D011084
Polycyclic Aromatic Hydrocarbons
D006841
Hydrocarbons, Aromatic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
D011083
Polycyclic Compounds
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
3
BG0052
BG0064
BG0074
BG0085
BG0094
BG0107
BG01139
3
BG0053
BG0063
BG0078
BG0088
BG0091
BG0106
BG01145
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
2
BG0051
BG0061
BG0072
BG0080
BG0090
BG0100
BG01113
1
BG0052
BG0067
BG0076
BG0088
BG0098
BG0108
BG01147
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
6
OG0044
OG0056
OG0065
OG0074
581.782
± 32.29
OG0041600.953± 40.01
OG0051632.595± 42.84
OG0062866.855± 51.29
OG0071105.999± 18.47
8
3209.396
± 37.31
6
OG0044
OG0056
OG0062
OG0074
7726.17
± 45.23
OG00317018.43± 62.60
OG00455406.24± 41.35
OG00566185.70± 71.44
OG006NA± NAGeometric mean/CV was not calculated due to n=2. Minimum and maximum values = 63062.0, 83978.0.