A Study of LY3502970 in Healthy Participants | NCT03929744 | Trialant
NCT03929744
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jul 10, 2026Actual
Enrollment
133Actual
Phase
Phase 1
Conditions
Healthy
Interventions
LY3502970
Placebo
Atorvastatin
Simvastatin
Midazolam
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
NCT03929744
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
17416
Secondary IDs
ID
Type
Description
Link
J2A-MC-GZGA
Other Identifier
Eli Lilly and Company
Brief Title
A Study of LY3502970 in Healthy Participants
Official Title
A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3502970 in Healthy Subjects
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jun 2026
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
Jun 12, 2019Actual
Primary Completion Date
Nov 2, 2020Actual
Completion Date
Nov 2, 2020Actual
First Submitted Date
Apr 25, 2019
First Submission Date that Met QC Criteria
Apr 25, 2019
First Posted Date
Apr 29, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Apr 30, 2026
Results First Submitted that Met QC Criteria
Jun 15, 2026
Results First Posted Date
Jul 10, 2026Actual
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
Jun 15, 2026
Last Update Posted Date
Jul 10, 2026Actual
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
Yes
Is FDA Regulated Device
No
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 main purposes of this study are to determine:
The safety of LY3502970 and any side effects that might be associated with it.
How much LY3502970 gets into the bloodstream and how long it takes the body to get rid of it.
This study has 5 parts (A, B, C, D, and E). Parts A and D involve a single dose of LY3502970 and will last about 15 days. Part B and E involve multiple doses of LY3502970 and will last about 4 weeks. Part C involves two single doses of LY3502970 and will last about 29 days. Each participant will enroll in only one part. Screening must be completed within 28 days before study start. This study is for research purposes only, and is not intended to treat any medical condition.
Detailed Description
Not provided
Conditions Module
Conditions
Healthy
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
133Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A 0.3 mg LY3502970
Experimental
Participants received a single oral dose of 0.3 milligram (mg) LY3502970.
Drug: LY3502970
Part A 1 mg LY3502970
Experimental
Participants received a single oral dose of 1 mg LY3502970.
Drug: LY3502970
Part A 3 mg LY3502970
Experimental
Participants received a single oral dose of 3 mg LY3502970.
Drug: LY3502970
Part A 6 mg LY3502970
Experimental
Participants received a single oral dose of 6 mg LY3502970.
Drug: LY3502970
Part A Placebo
Placebo Comparator
Participants received a single oral dose of Placebo.
Drug: Placebo
Part B Placebo
Placebo Comparator
Participants received oral doses of placebo once daily for 4 weeks.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY3502970
Drug
Administered orally.
Part A 0.3 mg LY3502970
Part A 1 mg LY3502970
Part A 3 mg LY3502970
Part A 6 mg LY3502970
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Parts A and B: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. An overall summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Baseline through Follow-up (up to Day 42)
Secondary Outcomes
Measure
Description
Time Frame
Part A: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. doi: 10.1007/s13300-024-01554-1. Epub 2024 Feb 24.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A Placebo
Participants received a single oral dose of Placebo.
FG001
Part A 0.3 mg LY3502970
Participants received a single oral dose of 0.3 milligram (mg) LY3502970.
FG002
Part A 1 mg LY3502970
Participants received a single oral dose of 1 mg LY3502970.
FG003
Part A 3 mg LY3502970
Participants received a single oral dose of 3 mg LY3502970.
FG004
Part A 6 mg LY3502970
Participants received a single oral dose of 6 mg LY3502970.
FG005
Part B Placebo
Participants received oral doses of placebo once daily for 4 weeks.
FG006
Part B: 2 mg LY3502970 (Cohort G)
Participants received oral doses of 2 mg LY3502970 once daily for 4 weeks.
FG007
Part B: 2 / 4 / 6 mg LY3502970 (Cohort H)
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week followed by 6 mg on the third and fourth week.
FG008
Part B: 2 / 4 / 8 / 16 mg LY3502970 (Cohort I)
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week, 8 mg for third week and 16 mg for fourth week.
FG009
Part B: 2 / 5 / 12 / 24 mg LY3502970 (Cohort J)
Participants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week. On day 27, midazolam 200 microgram (mcg) was coadministered with 24 mg LY3502970, and 40 mg atorvastatin administered 4 hours after midazolam.
FG010
Part B: 2 / 5 / 12 / 24 mg LY3502970 (Cohort K)
Participants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week. On day 27, 20 mg simvastatin was coadministered with 24 mg LY3502970.
FG011
Part C: 3 mg LY3502970 (Fasted/Fed)
Participants received a single oral dose of 3 mg LY3502970 in treatment period 1 (fasted condition), followed by administration in treatment period 2 (fed condition), with a washout period of at least 5 days between periods.
FG012
Part C: 3 mg LY3502970 (Fed/Fasted)
Participants received a single oral dose of 3 mg LY3502970 in treatment period1 (fed condition), followed by administration in treatment period 2 (fasted condition), with a washout period of at least 5 days between periods.
FG013
Part D: 3 mg LY3502970 Prototype Formulation
Participants received a single oral dose of 3 mg LY3502970 in a controlled-release prototype formulation.
FG014
Part D: Placebo Prototype Formulation
Participants received a single oral dose of placebo in a controlled-release prototype formulation.
FG015
Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 1)
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 1 for the fourth week.
FG016
Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 2)
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 2 for the fourth week.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0008 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0046 subjects
FG00515 subjects
FG0069 subjects
FG0079 subjects
FG0089 subjects
FG0099 subjects
FG0109 subjects
FG0116 subjectsIn Part C, participants were randomised to either the fasted/fed sequence or the fed/fasted sequence. A crossover between fasted and fed conditions occurred within each sequence, and each subject served as his or her own control.
FG0126 subjectsIn Part C, participants were randomised to either the fasted/fed sequence or the fed/fasted sequence. A crossover between fasted and fed conditions occurred within each sequence, and each subject served as his or her own control.
FG0136 subjects
FG0142 subjects
FG01511 subjects
FG01610 subjects
Received at Least One Dose of Study Drug
FG0008 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
COMPLETED
FG0008 subjects
FG0016 subjects
FG0026 subjects
FG0034 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
All enrolled participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A Placebo
Participants received a single oral dose of Placebo.
BG001
Part A 0.3 mg LY3502970
Participants received a single oral dose of 0.3 mg LY3502970.
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, Categorical
Count of Participants
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
Parts A and B: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. An overall summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
All participants in parts A and B who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in part B.
Posted
Count of Participants
Participants
No
Baseline through Follow-up (up to Day 42)
Adverse Events Module
Frequency Threshold
5
Time Frame
Baseline through Follow-up (up to Day 42)
Description
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
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
Part A Placebo
Participants received a single oral dose of Placebo.
Participants received oral doses of 2 mg LY3502970 once daily for 4 weeks.
Drug: LY3502970
Part B: 2 / 4 / 6 mg LY3502970 (Cohort H)
Experimental
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week followed by 6 mg on the third and fourth week.
Drug: LY3502970
Part B: 2 / 4 / 8 / 16 mg LY3502970 (Cohort I)
Experimental
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week, 8 mg for third week and 16 mg for fourth week.
Drug: LY3502970
Part B: 2 / 5 / 12 / 24 mg LY3502970 (Cohort J)
Experimental
Participants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week. On day 27, midazolam 200 microgram (mcg) was coadministered with 24 mg LY3502970, and 40 mg atorvastatin administered 4 hours after midazolam.
Drug: LY3502970
Drug: Atorvastatin
Drug: Midazolam
Part B: 2 / 5 / 12 / 24 mg LY3502970 (Cohort K)
Experimental
Participants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week. On day 27, 20 mg simvastatin was coadministered with 24 mg LY3502970.
Drug: LY3502970
Drug: Simvastatin
Part C: 3 mg LY3502970 (Fasted/Fed)
Experimental
Part C of the study is exploratory, conducted to study exploratory objectives.
Participants received a single oral dose of 3 mg LY3502970 in treatment period 1 (fasted condition), followed by administration in treatment period 2 (fed condition), with a washout period of at least 5 days between periods.
Drug: LY3502970
Part C: 3 mg LY3502970 (Fed/Fasted)
Experimental
Part C of the study is exploratory, conducted to study exploratory objectives.
Participants received a single oral dose of 3 mg LY3502970 in treatment period1 (fed condition), followed by administration in treatment period 2 (fasted condition), with a washout period of at least 5 days between periods.
Drug: LY3502970
Part D: 3 mg LY3502970 Prototype Formulation
Active Comparator
Part D of the study is exploratory, conducted to study exploratory objectives.
Participants received a single oral dose of 3 mg LY3502970 in a controlled-release prototype formulation.
Drug: LY3502970
Part D: Placebo Prototype Formulation
Placebo Comparator
Part D of the study is exploratory, conducted to study exploratory objectives.
Participants received a single oral dose of placebo in a controlled-release prototype formulation.
Drug: Placebo
Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 1)
Experimental
Part E of the study is exploratory, conducted to study exploratory objectives.
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 1 for the fourth week.
Drug: LY3502970
Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 2)
Experimental
Part E of the study is exploratory, conducted to study exploratory objectives.
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 2 for the fourth week.
Drug: LY3502970
Part B: 2 / 4 / 6 mg LY3502970 (Cohort H)
Part B: 2 / 4 / 8 / 16 mg LY3502970 (Cohort I)
Part B: 2 / 5 / 12 / 24 mg LY3502970 (Cohort J)
Part B: 2 / 5 / 12 / 24 mg LY3502970 (Cohort K)
Part B: 2 mg LY3502970 (Cohort G)
Part C: 3 mg LY3502970 (Fasted/Fed)
Part C: 3 mg LY3502970 (Fed/Fasted)
Part D: 3 mg LY3502970 Prototype Formulation
Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 1)
Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 2)
FG0079 subjectsReceived at least one dose of 2 mg = 9, 4 mg = 9, 6 mg = 8.
FG0089 subjectsReceived at least one dose of 2 mg = 9, 4 mg = 9, 8 mg = 9, 16 mg = 8.
FG0099 subjectsReceived at least one dose of 2 mg = 9, 5 mg = 9, 12 mg = 9, 24 mg = 9.
FG0109 subjectsReceived at least one dose of 2 mg = 9, 5 mg = 8, 12 mg = 8, 24 mg = 8.
FG0116 subjects* Received the study drug in treatment period 1 (fasted condition) = 6
* Received the study drug in treatment period 2 (fed condition) = 6
FG0126 subjects* Received the study drug in treatment period 1 (fed condition) = 6
* Received the study drug in treatment period 2 (fasted condition) = 6
FG0136 subjects
FG0142 subjects
FG01511 subjectsReceived at least one dose of 2 mg = 11, 5 mg = 10, 12 mg = 9, 24 mg formulation 1 = 9
FG01610 subjectsReceived at least one dose of 2 mg = 10, 5 mg = 10, 12 mg = 10, 24 mg formulation 2 = 10
6 subjects
FG00513 subjects
FG0068 subjects
FG0078 subjects
FG0087 subjects
FG0099 subjects
FG0108 subjects
FG0116 subjects
FG0126 subjects
FG0135 subjects
FG0142 subjects
FG0159 subjects
FG01610 subjects
0 subjects
FG0052 subjects
FG0061 subjects
FG0071 subjects
FG0082 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
FG0140 subjects
FG0152 subjects
FG0160 subjects
2 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0151 subjects
FG0160 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0151 subjects
FG0160 subjects
BG002
Part A 1 mg LY3502970
Participants received a single oral dose of 1 mg LY3502970.
BG003
Part A 3 mg LY3502970
Participants received a single oral dose of 3 mg LY3502970.
BG004
Part A 6 mg LY3502970
Participants received a single oral dose of 6 mg LY3502970.
BG005
Part B Placebo
Participants received oral doses of placebo once daily for 4 weeks.
BG006
Part B: 2 mg LY3502970 (Cohort G)
Participants received oral doses of 2 mg LY3502970 once daily for 4 weeks.
BG007
Part B: 2 / 4 / 6 mg LY3502970 (Cohort H)
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week followed by 6 mg on the third and fourth week.
BG008
Part B: 2 / 4 / 8 / 16 mg LY3502970 (Cohort I)
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week, 8 mg for third week and 16 mg for fourth week.
BG009
Part B: 2 / 5/ 12 / 24 mg LY3502970 (Cohort J)
Participants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week. On day 27, midazolam 200 mcg was coadministered with 24 mg LY3502970, and 40 mg atorvastatin administered 4 hours after midazolam.
BG010
Part B: 2 / 5/ 12 / 24 mg LY3502970 (Cohort K)
Participants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week. On day 27, 20 mg simvastatin was coadministered with 24 mg LY3502970.
BG011
Part C: 3 mg LY3502970 (Fasted/Fed)
Participants received a single oral dose of 3 mg LY3502970 in treatment period 1 (fasted condition), followed by administration in treatment period 2 (fed condition), with a washout period of at least 5 days between periods.
BG012
Part C: 3 mg LY3502970 (Fed/Fasted)
Participants received a single oral dose of 3 mg LY3502970 in treatment period1 (fed condition), followed by administration in treatment period 2 (fasted condition), with a washout period of at least 5 days between periods.
BG013
Part D: 3 mg LY3502970 Prototype Formulation
Participants received a single oral dose of 3 mg LY3502970 in a controlled-release prototype formulation.
BG014
Part D: Placebo Prototype Formulation
Participants received a single oral dose of placebo in a controlled-release prototype formulation.
BG015
Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 1)
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 1 for the fourth week.
BG016
Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 2)
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 2 for the fourth week.
BG017
Total
Total of all reporting groups
8
BG0016
BG0026
BG0036
BG0046
BG00515
BG0069
BG0079
BG0089
BG0099
BG0109
BG0116
BG0126
BG0136
BG0142
BG01511
BG01610
BG017133
Participants
No
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
Between 18 and 65 years
BG0008
BG0016
BG0026
BG0036
BG004
>=65 years
BG0000
BG0010
BG0020
BG0030
BG004
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0013
BG0023
BG0031
BG0044
BG0053
BG0063
BG0072
BG0084
BG0090
BG0104
BG0111
BG0123
BG0132
BG0141
BG0151
BG0161
BG01738
Male
BG0006
BG0013
BG0023
BG0035
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0005
BG0011
BG0021
BG0031
BG0042
BG0055
BG0062
BG0075
BG0082
BG0092
BG0105
BG0112
BG0122
BG0131
BG0141
BG0153
BG0161
BG01741
Not Hispanic or Latino
BG0003
BG0015
BG0025
BG0035
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
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
Asian
BG0000
BG0011
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0001
BG0012
BG0023
BG0030
BG004
White
BG0007
BG0013
BG0023
BG0036
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
BG0008
BG0016
BG0026
BG0036
BG0046
BG00515
BG0069
BG0079
BG0089
BG0099
BG0109
BG0116
BG0126
BG0136
BG0142
BG01511
BG01610
BG017133
ID
Title
Description
OG000
Part A Placebo
Participants received a single oral dose of Placebo.
OG001
Part A 0.3 mg LY3502970
Participants received a single oral dose of 0.3 mg LY3502970.
OG002
Part A 1 mg LY3502970
Participants received a single oral dose of 1 mg LY3502970.
OG003
Part A 3 mg LY3502970
Participants received a single oral dose of 3 mg LY3502970.
OG004
Part A 6 mg LY3502970
Participants received a single oral dose of 6 mg LY3502970.
OG005
Part B Placebo
Participants received oral doses of placebo once daily for 4 weeks.
OG006
Part B: 2 mg LY3502970
Participants received 2 mg LY3502970 (cohorts G, H, I, J, K).
OG007
Part B: 4 mg LY3502970
Participants received 4 mg LY3502970 (cohorts H, I).
OG008
Part B: 5 mg LY3502970
Participants received 5 mg LY3502970 (cohorts J, K).
OG009
Part B: 6 mg LY3502970
Participants received 6 mg LY3502970 (cohort H).
OG010
Part B: 8 mg LY3502970
Participants received 8 mg LY3502970 (cohort I).
OG011
Part B: 12 mg LY3502970
Participants received 12 mg LY3502970 (cohorts J, K).
OG012
Part B: 16 mg LY3502970
Participants received 16 mg LY3502970 (cohort I).
OG013
Part B: 24 mg LY3502970
Participants received 24 mg LY3502970 (cohorts J, K).
Units
Counts
Participants
OG0008
OG0016
OG0026
OG0036
OG0046
OG00515
OG00645
OG00718
OG00817
OG0098
OG0109
OG01117
OG0128
OG01317
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
Secondary
Part A: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
PK: Cmax of LY3502970
Part A: All participants who received at least one dose of LY3502970 and had evaluable PK data.
Participants received a single oral dose of 0.3 mg LY3502970.
OG001
Part A 1 mg LY3502970
Participants received a single oral dose of 1 mg LY3502970.
OG002
Part A 3 mg LY3502970
Participants received a single oral dose of 3 mg LY3502970.
OG003
Part A 6 mg LY3502970
Participants received a single oral dose of 6 mg LY3502970.
Units
Counts
Participants
OG0006
OG0016
OG0024
OG0032
Title
Denominators
Categories
Title
Measurements
OG0008(4.05 to 16.15)
OG0014.05(4.05 to 8)
OG0026.04(4.05 to 8)
OG003
Secondary
Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 1
PK: Cmax of LY3502970
Part B: All participants who received LY3502970 on Day 1 and had evaluable PK data. Per protocol, PK analysis was conducted by treatment dose. On day 1, participants in all the cohorts (G-K) received 2 mg LY3502970, therefore, Cmax of LY3502970 for the 2 mg treatment dose was reported.
Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 28
PK: Cmax of LY3502970
Part B: All participants who received LY3502970 on Day 28 and had evaluable PK data. Per protocol, PK analysis was conducted by treatment dose. On Day 28, participants in cohort G received 2 mg, H received 6 mg, I received 16 mg, J and K received 24 mg of LY3502970. Therefore, Cmax of LY3502970 for the respective treatment doses were reported.
Part B: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 1
PK: AUC(0-tlast) of LY3502970
Part B: All participants who received LY3502970 on Day 1 and had evaluable PK data. Per protocol, PK analysis was conducted by treatment dose. On day 1, participants in all the cohorts (G-K) received 2 mg LY3502970, therefore, AUC(0-tlast) of LY3502970 for the 2 mg treatment dose was reported.
Part B: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 28
PK: AUC(0-tlast) of LY3502970
Part B: All participants who received LY3502970 on Day 28 and had evaluable PK data. Per protocol, PK analysis was conducted by treatment dose. On Day 28, participants in cohort G received 2 mg, H received 6 mg, I received 16 mg, J and K received 24 mg of LY3502970. Therefore, AUC(0-tlast) of LY3502970 for the respective treatment doses were reported.
Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 on Day 1
PK: Tmax of LY3502970
Part B: All participants who received LY3502970 on Day 1 and had evaluable PK data. Per protocol, PK analysis was conducted by treatment dose. On day 1, participants in all the cohorts (G-K) received 2 mg LY3502970, therefore, Tmax of LY3502970 for the 2 mg treatment dose was reported.
Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 on Day 28
PK: Tmax of LY3502970
Part B: All participants who received LY3502970 on Day 28 and had evaluable PK data. Per protocol, PK analysis was conducted by treatment dose. On Day 28, participants in cohort G received 2 mg, H received 6 mg, I received 16 mg, J and K received 24 mg of LY3502970. Therefore, Tmax of LY3502970 for the respective treatment doses were reported.
Participants received a single oral dose of 0.3 mg LY3502970.
0
6
0
6
1
6
EG002
Part A 1 mg LY3502970
Participants received a single oral dose of 1 mg LY3502970.
0
6
0
6
1
6
EG003
Part A 3 mg LY3502970
Participants received a single oral dose of 3 mg LY3502970.
0
6
0
6
3
6
EG004
Part A 6 mg LY3502970
Participants received a single oral dose of 6 mg LY3502970.
0
6
0
6
5
6
EG005
Part B Placebo QD
Participants received oral doses of placebo once daily for 4 weeks.
0
15
0
15
4
15
EG006
Part B 2 mg LY3502970 QD
Participants received 2 mg LY3502970 (cohorts G, H, I, J, K).
0
45
0
45
16
45
EG007
Part B 4 mg LY3502970 QD
Participants received 4 mg LY3502970 (cohorts H, I).
0
18
0
18
8
18
EG008
Part B 5 mg LY3502970 QD
Participants received 5 mg LY3502970 (cohorts J, K).
0
17
0
17
6
17
EG009
Part B 6 mg LY3502970 QD
Participants received 6 mg LY3502970 (cohort H).
0
8
0
8
5
8
EG010
Part B 8 mg LY3502970 QD
Participants received 8 mg LY3502970 (cohort I).
0
9
0
9
6
9
EG011
Part B 12 mg LY3502970 QD
Participants received 12 mg LY3502970 (cohorts J, K).
0
17
0
17
8
17
EG012
Part B 16 mg LY3502970 QD
Participants received 16 mg LY3502970 (cohort I).
0
8
0
8
2
8
EG013
Part B 24 mg LY3502970 QD
Participants received 24 mg LY3502970 (cohorts J, K).
0
17
0
17
9
17
EG014
Part C 3 mg LY3502970 Fasted
Participants received a 3 mg LY3502970 in fasted conditions.
0
12
0
12
2
12
EG015
Part C 3 mg LY3502970 Fed
Participants received a 3 mg LY3502970 in fed conditions.
0
12
0
12
0
12
EG016
Part D: 3 mg LY3502970 Prototype Formulation
Participants received a single oral dose of 3 mg LY3502970 in a controlled-release prototype formulation.
0
6
0
6
2
6
EG017
Part D: Placebo Prototype Formulation
Participants received a single oral dose of placebo in a controlled-release prototype formulation.
0
2
0
2
0
2
EG018
Part E 2 mg LY3502970 QD
Participants received 2 mg LY3502970.
0
21
0
21
4
21
EG019
Part E 5 mg LY3502970 QD
Participants received 5 mg LY3502970.
0
20
0
20
4
20
EG020
Part E 12 mg LY3502970 QD
Participants received 12 mg LY3502970.
0
19
0
19
6
19
EG021
Part E 24 mg LY3502970 QD
Participants received 24 mg LY3502970 as either formulation 1 or formulation 2.
0
19
0
19
5
19
EG022
Part E 24 mg LY3502970 Formulation 1 QD
Participants received 24 mg LY3502970 as formulation 1.
0
9
0
9
0
9
EG023
Part E 24 mg LY3502970 Formulation 2 QD
Participants received 24 mg LY3502970 as formulation 2.
0
10
0
10
1
10
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0061 events1 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0111 events1 affected17 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0161 events1 affected6 at risk
EG0170 events0 affected2 at risk
EG0181 events1 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0211 events1 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected15 at risk
EG0066 events6 affected45 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0181 events1 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0161 events1 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0141 events1 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Constipation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0065 events5 affected45 at risk
EG0076 events6 affected18 at risk
EG0083 events3 affected17 at risk
EG0091 events1 affected8 at risk
EG0102 events2 affected9 at risk
EG0112 events2 affected17 at risk
EG0120 events0 affected8 at risk
EG0132 events2 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0161 events1 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0191 events1 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0062 events1 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0121 events1 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected9 at risk
EG0112 events1 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0181 events1 affected21 at risk
EG0191 events1 affected20 at risk
EG0201 events1 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Eructation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0201 events1 affected19 at risk
EG0211 events1 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Flatulence
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0181 events1 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Haematochezia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0034 events3 affected6 at risk
EG0043 events3 affected6 at risk
EG0050 events0 affected15 at risk
EG0065 events5 affected45 at risk
EG0074 events4 affected18 at risk
EG0081 events1 affected17 at risk
EG0094 events4 affected8 at risk
EG0103 events3 affected9 at risk
EG0114 events3 affected17 at risk
EG0121 events1 affected8 at risk
EG0132 events2 affected17 at risk
EG0142 events2 affected12 at risk
EG0150 events0 affected12 at risk
EG0161 events1 affected6 at risk
EG0170 events0 affected2 at risk
EG0182 events2 affected21 at risk
EG0191 events1 affected20 at risk
EG0204 events4 affected19 at risk
EG0213 events3 affected19 at risk
EG0220 events0 affected9 at risk
EG0231 events1 affected10 at risk
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0037 events3 affected6 at risk
EG0046 events4 affected6 at risk
EG0050 events0 affected15 at risk
EG0062 events2 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected9 at risk
EG0111 events1 affected17 at risk
EG0120 events0 affected8 at risk
EG0135 events3 affected17 at risk
EG0141 events1 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0184 events3 affected21 at risk
EG0190 events0 affected20 at risk
EG0204 events3 affected19 at risk
EG0211 events1 affected19 at risk
EG0220 events0 affected9 at risk
EG0231 events1 affected10 at risk
Asthenia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0111 events1 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Chest discomfort
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Chills
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0211 events1 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Medical device site irritation
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0111 events1 affected17 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0191 events1 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Skin infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Electrocardiogram t wave inversion
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected15 at risk
EG0064 events4 affected45 at risk
EG0071 events1 affected18 at risk
EG0081 events1 affected17 at risk
EG0091 events1 affected8 at risk
EG0101 events1 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0182 events2 affected21 at risk
EG0190 events0 affected20 at risk
EG0202 events2 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0052 events1 affected15 at risk
EG0061 events1 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Dizziness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0063 events3 affected45 at risk
EG0072 events2 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected9 at risk
EG0111 events1 affected17 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected17 at risk
EG0141 events1 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0201 events1 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0042 events2 affected6 at risk
EG0050 events0 affected15 at risk
EG0064 events3 affected45 at risk
EG0074 events4 affected18 at risk
EG0081 events1 affected17 at risk
EG0094 events3 affected8 at risk
EG0100 events0 affected9 at risk
EG0114 events4 affected17 at risk
EG0120 events0 affected8 at risk
EG0136 events5 affected17 at risk
EG0141 events1 affected12 at risk
EG0150 events0 affected12 at risk
EG0161 events1 affected6 at risk
EG0170 events0 affected2 at risk
EG0181 events1 affected21 at risk
EG0191 events1 affected20 at risk
EG0203 events2 affected19 at risk
EG0211 events1 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Memory impairment
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0052 events1 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Somnolence
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0061 events1 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0111 events1 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Tremor
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0062 events2 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0132 events1 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0121 events1 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected15 at risk
EG0061 events1 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0161 events1 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected17 at risk
EG0141 events1 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0161 events1 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0141 events1 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0121 events1 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
Hot flush
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected17 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected17 at risk
EG0140 events0 affected12 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected21 at risk
EG0190 events0 affected20 at risk
EG0200 events0 affected19 at risk
EG0210 events0 affected19 at risk
EG0220 events0 affected9 at risk
EG0230 events0 affected10 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Neither Lilly or Supplier shall publish, discuss, or release data emanating from a study without the other party's express written permission which shall not be unreasonably withheld. Nothing herein shall limit supplier's right to respond to legal inquiries.