A Multiple Dose Study of LY3502970 in Healthy Overweight... | NCT05841238 | Trialant
NCT05841238
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jul 10, 2026Actual
Enrollment
52Actual
Phase
Phase 1
Conditions
Healthy
Obese
Interventions
LY3502970
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
NCT05841238
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
18527
Secondary IDs
ID
Type
Description
Link
J2A-MC-GZGN
Other Identifier
Eli Lilly and Company
Brief Title
A Multiple Dose Study of LY3502970 in Healthy Overweight and Obese Participants
Official Title
A Multiple Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Tablet and Capsule Formulations of LY3502970 in Healthy Overweight and Obese Participants
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
Apr 26, 2023Actual
Primary Completion Date
Sep 14, 2023Actual
Completion Date
Nov 13, 2023Actual
First Submitted Date
Apr 24, 2023
First Submission Date that Met QC Criteria
Apr 24, 2023
First Posted Date
May 3, 2023Actual
Results Waived
Not provided
Results First Submitted Date
Apr 29, 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 purpose of this study is to evaluate how much LY3502970 gets into the bloodstream and how long it takes the body to eliminate when administered orally as tablet and capsule formulations along with effect of food on LY3502970 in healthy overweight and obese participants. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study is conducted in two parts (part A and B) and will last up to 135 days including the screening period.
Detailed Description
Not provided
Conditions Module
Conditions
Healthy
Obese
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
52Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A: LY3502970 (Periods 1 to 11)
Experimental
Participants received a once daily (QD) oral dose of LY3502970 in the tablet or capsule formulation, depending on the period of the study, throughout Periods 1 to 11 as follows:
Period 2 (Day 8-14): 2 mg LY3502970 capsule (fasted state)
Period 3 (Day 15-21): 2.5 mg LY3502970 tablet (fasted state)
Period 4 (Day 22-28): 5 mg LY3502970 tablet (fasted state)
Period 5 (Day 29-35): 8 mg LY3502970 capsule (fasted state)
Period 6 (Day 36-42): 10 mg LY3502970 tablet (fasted state)
Period 7 (Day 43-49): 16 mg LY3502970 capsule (fasted state)
Period 8 (Day 50-56): 20 mg LY3502970 tablet (fasted state)
Period 9 (Day 57-63): 36 mg LY3502970 capsule (fasted state)
Period 10 (Day 64-70): 36 mg LY3502970 capsule or 37.5 mg LY3502970 tablet (fed state)
Period 11 (Day 71-77): 37.5 mg LY3502970 tablet (fasted state)
Drug: LY3502970
Part B: 45 mg LY3502970 / 60 mg LY3502970 (Periods 12 to 13)
Experimental
Participants after completion of Part A (Periods 1-11), in Part B received a QD oral dose of LY3502970 as follows:
Period 12 (Day 78-84): 45 mg LY3502970 tablet (fasted state)
Period 13 (Day 85-91): 60 mg LY3502970 tablet (fasted state)
Drug: LY3502970
Part B: 35 mg LY3502970 / 35 mg LY3502970 (Periods 12 to 13)
Experimental
Participants after completion of Part A (Periods 1-11), in Part B received a QD oral dose of LY3502970 as follows:
Period 12 (Day 78-84): 35 mg LY3502970 tablet (fasted state)
Period 13 (Day 85-91): 35 mg LY3502970 tablet (fasted state)
Drug: LY3502970
Part B: 36 mg LY3502970 DF / 36 mg LY3502970 EPB (Periods 12 to 13)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY3502970
Drug
Administered orally.
Part A: LY3502970 (Periods 1 to 11)
Part B: 35 mg LY3502970 / 35 mg LY3502970 (Periods 12 to 13)
Part B: 36 mg LY3502970 DF / 36 mg LY3502970 EPB (Periods 12 to 13)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13
PK: AUC[0-24] of LY3502970 in fasted state
Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13
PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13
PK: Cmax of LY3502970 in fasted state
Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13
PK: Tmax of LY3502970 in fasted state
Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13
Secondary Outcomes
Measure
Description
Time Frame
PK: Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fed State - Part A: Period 10
PK: AUC[0-24] of LY3502970 in fed state
Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)
PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fed State - Part A: Period 10
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female participants who are overtly healthy as determined by medical evaluation
Participants with body mass index (BMI) of 27.0 kilograms per meter squared (kg/m²) or more
Participants with a stable body weight, with 5% or less body weight gain or loss
Exclusion Criteria:
Have any type of diabetes with hemoglobin A1c (HbA1c) level of 6.5% or greater or a fasting blood sugar over 120 milligram per deciliter (mg/dL)
Obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome
Have known clinically significant gastric emptying abnormality
Have undergone bariatric surgery (for example: Lap-Band, Gastric Bypass)
Known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or any form of thyroid cancer
Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drug
Have significant history of or currently have Major Depressive Disorder or psychiatric disorder within the last 2 years
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
LabCorp CRU, Inc.
Daytona Beach
Florida
32117
United States
Labcorp Clinical Research LP
References Module
No data available
No data is available for this block.
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
The study had two sequential parts ; Part A and Part B. Part A consisted of dosing periods 1 to 11 and Part B consisted of dosing periods 12 and 13. Participants enrolled in the study, began in Part A, and continued into Part B.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: LY3502970 (Periods 1 to 11)
Participants received a once daily (QD) oral dose of LY3502970 in the tablet or capsule formulation, depending on the period of the study, throughout Periods 1 to 11 as follows:
All enrolled participants who received at least one dose of study drug.
FG00052 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
FG00050 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG003
Period 2 to Period 3
Type
Comment
Milestone Data
STARTED
All enrolled participants who received at least one dose of study drug.
FG00050 subjects
FG0010 subjects
FG0020 subjects
FG003
Period 4
Type
Comment
Milestone Data
STARTED
All enrolled participants who received at least one dose of study drug.
FG00050 subjects
FG0010 subjects
FG0020 subjects
FG003
Period 5
Type
Comment
Milestone Data
STARTED
All enrolled participants who received at least one dose of study drug.
FG00049 subjects
FG0010 subjects
FG0020 subjects
FG003
Period 6
Type
Comment
Milestone Data
STARTED
All enrolled participants who received at least one dose of study drug.
FG00049 subjects
FG0010 subjects
FG0020 subjects
FG003
Period 7
Type
Comment
Milestone Data
STARTED
All enrolled participants who received at least one dose of study drug.
FG00046 subjects
FG0010 subjects
FG0020 subjects
FG003
Period 8
Type
Comment
Milestone Data
STARTED
All enrolled participants who received at least one dose of study drug.
FG00046 subjects
FG0010 subjects
FG0020 subjects
FG003
Period 9
Type
Comment
Milestone Data
STARTED
All enrolled participants who received at least one dose of study drug.
FG00045 subjects
FG0010 subjects
FG0020 subjects
FG003
Period 10: 36 mg LY3502970 Capsule
Type
Comment
Milestone Data
STARTED
All enrolled participants who received at least one dose of study drug.
FG00021 subjects
FG0010 subjects
FG0020 subjects
FG003
Period 10: 37.5 mg LY3502970 Tablet
Type
Comment
Milestone Data
STARTED
All enrolled participants who received at least one dose of study drug.
FG00021 subjects
FG0010 subjects
FG0020 subjects
FG003
Period 11
Type
Comment
Milestone Data
STARTED
All enrolled participants who received at least one dose of study drug.
FG00041 subjects
FG0010 subjects
FG0020 subjects
FG003
Periods 12 to 13
Type
Comment
Milestone Data
STARTED
All enrolled participants who received at least one dose of study drug.
FG0000 subjects
FG0017 subjectsParticipants who completed Part A continued into Part B (Periods 12 and 13).
FG00221 subjectsParticipants who completed Part A continued into Part B (Periods 12 and 13).
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
All enrolled participants (period 1).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: LY3502970 (Periods 1 to 11)
Participants received a QD oral dose of LY3502970 in the tablet or capsule formulation, depending on the period of the study, throughout Periods 1 to 11 as follows:
Period 1 (Day 1-7): 0.8 mg LY3502970 tablet (fasted state)
Period 2 (Day 8-14): 2 mg LY3502970 capsule (fasted state)
Period 3 (Day 15-21): 2.5 mg LY3502970 tablet (fasted state)
Period 4 (Day 22-28): 5 mg LY3502970 tablet (fasted state)
Period 5 (Day 29-35): 8 mg LY3502970 capsule (fasted state)
Period 6 (Day 36-42): 10 mg LY3502970 tablet (fasted state)
Period 7 (Day 43-49): 16 mg LY3502970 capsule (fasted state)
Period 8 (Day 50-56): 20 mg LY3502970 tablet (fasted state)
Period 9 (Day 57-63): 36 mg LY3502970 capsule (fasted state)
Period 10 (Day 64-70): 36 mg LY3502970 capsule or 37.5 mg LY3502970 tablet (fed state)
Period 11 (Day 71-77): 37.5 mg LY3502970 tablet (fasted state)
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
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13
PK: AUC[0-24] of LY3502970 in fasted state
All enrolled participants who received at least one dose of study drug in Part A: periods 1-9, 11 and Part B: periods 12-13 (fasted state) and had evaluable PK data for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram*hour per milliliter (ng*h/mL)
Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13
ID
Title
Description
OG000
Part A: Period 1 (Day 1-7): 0.8 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 0.8 mg LY3502970 tablet in fasted state from Day 1 to Day 7 are grouped under this arm.
Adverse Events Module
Frequency Threshold
5
Time Frame
Baseline to end of follow-up (up to 15 weeks)
Description
All enrolled participants who received at least one dose of study drug in Part A (periods 1-11) and Part B (periods 12-13). Participants were analyzed and reported based on the actual treatment they received.
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: Period 1 (Day 1-7): 0.8 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 0.8 mg LY3502970 tablet in fasted state from Day 1 to Day 7 are grouped under this arm.
Part B: 45 mg LY3502970 / 60 mg LY3502970 (Periods 12 to 13)
PK: Cmax of LY3502970 in fed state
Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fed State - Part A: Period 10
PK: Tmax of LY3502970 in fed state
Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)
Dallas
Texas
75247
United States
LabCorp CRU, Inc.
Madison
Wisconsin
53704
United States
0 subjects
0 subjects
COMPLETED
FG00050 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
0 subjects
COMPLETED
FG00049 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
0 subjects
COMPLETED
FG00049 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
0 subjects
COMPLETED
FG00046 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Type
Comment
Reasons
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Use of Prohibited Concomitant Medication
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Non-compliance with Study Requirements
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
0 subjects
COMPLETED
FG00046 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
0 subjects
COMPLETED
FG00045 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
0 subjects
COMPLETED
FG00042 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
0 subjects
COMPLETED
FG00020 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Type
Comment
Reasons
Protocol deviation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
0 subjects
COMPLETED
FG00021 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
0 subjects
COMPLETED
FG00040 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
12 subjects
Participants who completed Part A continued into Part B (Periods 12 and 13).
COMPLETED
FG0000 subjects
FG0017 subjects
FG00221 subjects
FG00312 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
52
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00042.3± 11.9
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00023
Male
BG00029
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00020
Not Hispanic or Latino
BG00032
Unknown or Not Reported
BG0000
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
Asian
BG0000
Native Hawaiian or Other Pacific Islander
BG0000
Black or African American
BG00025
White
BG00027
More than one race
BG0000
Unknown or Not Reported
BG0000
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
United States
Title
Measurements
BG00052
OG001
Part A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State)
Participants who received a QD oral dose of 2 mg LY3502970 capsule in fasted state from Day 8 to Day 14 are grouped under this arm.
OG002
Part A: Period 3 (Day 15-21): 2.5 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 2.5 mg LY3502970 tablet in fasted state from Day 15 to Day 21 are grouped under this arm.
OG003
Part A: Period 4 (Day 22-28): 5 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 5 mg LY3502970 tablet in fasted state from Day 22 to Day 28 are grouped under this arm.
OG004
Part A: Period 5 (Day 29-35): 8 mg LY3502970 Capsule (Fasted State)
Participants who received a QD oral dose of 8 mg LY3502970 capsule in fasted state from Day 29 to Day 35 are grouped under this arm.
OG005
Part A: Period 6 (Day 36-42): 10 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 10 mg LY3502970 tablet in fasted state from Day 36 to Day 42 are grouped under this arm.
OG006
Part A: Period 7 (Day 43-49): 16 mg LY3502970 Capsule (Fasted State)
Participants who received a QD oral dose of 16 mg LY3502970 capsule in fasted state from Day 43 to Day 49 are grouped under this arm.
OG007
Part A: Period 8 (Day 50-56): 20 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 20 mg LY3502970 tablet in fasted state from Day 50 to Day 56 are grouped under this arm.
OG008
Part A: Period 9 (Day 57-63): 36 mg LY3502970 Capsule (Fasted State)
Participants who received a QD oral dose of 36 mg LY3502970 capsule in fasted state from Day 57 to Day 63 are grouped under this arm.
OG009
Part A: Period 11 (Day 71-77): 37.5 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 37.5 mg LY3502970 tablet in fasted state from Day 71 to Day 77 are grouped under this arm.
OG010
Part B: Period 12 (Day 78-84): 35 mg LY3502970 Tablet (Fasted State)
Participants who completed Part A and received a QD oral dose of 35 mg LY3502970 tablet in fasted state from Day 78 to Day 84 are grouped under this arm.
OG011
Part B: Period 13 (Day 85-91): 35 mg LY3502970 Tablet (Fasted State)
Participants who completed Part A and received a QD oral dose of 35 mg LY3502970 tablet in fasted state from Day 85 to Day 91 are grouped under this arm.
OG012
Part B: Period 12 (Day 78-84): 45 mg LY3502970 Tablet (Fasted State)
Participants who completed Part A and received a QD oral dose of 45 mg LY3502970 tablet in fasted state from Day 78 to Day 84 are grouped under this arm.
OG013
Part B: Period 13 (Day 85-91): 60 mg LY3502970 Tablet (Fasted State)
Participants who completed Part A and received a QD oral dose of 60 mg LY3502970 tablet in fasted state from Day 85 to Day 91 are grouped under this arm.
OG014
Part B: Period 12 (Day 78-84): 36 mg LY3502970 DF Capsule (Fasted State)
Participants who completed Part A and received a QD oral dose of 36 mg LY3502970 DF capsule in fasted state from Day 78 to Day 84 are grouped under this arm.
OG015
Part B: Period 13 (Day 85-91): 36 mg LY3502970 EPB Capsule (Fasted State)
Participants who completed Part A and received a QD oral dose of 36 mg LY3502970 EPB capsule in fasted state from Day 85 to Day 91 are grouped under this arm.
Units
Counts
Participants
OG00050
OG00150
OG00250
OG00347
OG00449
OG00546
OG00641
OG00744
OG00843
OG00940
OG0107
OG0117
OG01220
OG01321
OG01412
OG01512
Title
Denominators
Categories
Title
Measurements
OG00090.8± 27
OG001199± 34
OG002294± 31
OG003548± 29
OG004700± 42
OG0051080± 32
OG0061250± 40
OG0071970± 48
OG0081580± 72
OG0093680± 47
OG0103730± 37
OG0114080± 40
OG0124100± 51
OG0136410± 49
OG0141950± 59
OG0153030± 45
Primary
PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13
PK: Cmax of LY3502970 in fasted state
All enrolled participants who received at least one dose of study drug in Part A: periods 1-9, 11 and Part B: periods 12-13 (fasted state) and had evaluable PK data for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter (ng/mL)
Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13
ID
Title
Description
OG000
Part A: Period 1 (Day 1-7): 0.8 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 0.8 mg LY3502970 tablet in fasted state from Day 1 to Day 7 are grouped under this arm.
OG001
Part A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State)
Participants who received a QD oral dose of 2 mg LY3502970 capsule in fasted state from Day 8 to Day 14 are grouped under this arm.
OG002
Part A: Period 3 (Day 15-21): 2.5 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 2.5 mg LY3502970 tablet in fasted state from Day 15 to Day 21 are grouped under this arm.
OG003
Part A: Period 4 (Day 22-28): 5 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 5 mg LY3502970 tablet in fasted state from Day 22 to Day 28 are grouped under this arm.
OG004
Part A: Period 5 (Day 29-35): 8 mg LY3502970 Capsule (Fasted State)
Participants who received a QD oral dose of 8 mg LY3502970 capsule in fasted state from Day 29 to Day 35 are grouped under this arm.
OG005
Part A: Period 6 (Day 36-42): 10 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 10 mg LY3502970 tablet in fasted state from Day 36 to Day 42 are grouped under this arm.
OG006
Part A: Period 7 (Day 43-49): 16 mg LY3502970 Capsule (Fasted State)
Participants who received a QD oral dose of 16 mg LY3502970 capsule in fasted state from Day 43 to Day 49 are grouped under this arm.
OG007
Part A: Period 8 (Day 50-56): 20 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 20 mg LY3502970 tablet in fasted state from Day 50 to Day 56 are grouped under this arm.
OG008
Part A: Period 9 (Day 57-63): 36 mg LY3502970 Capsule (Fasted State)
Participants who received a QD oral dose of 36 mg LY3502970 capsule in fasted state from Day 57 to Day 63 are grouped under this arm.
OG009
Part A: Period 11 (Day 71-77): 37.5 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 37.5 mg LY3502970 tablet in fasted state from Day 71 to Day 77 are grouped under this arm.
OG010
Part B: Period 12 (Day 78-84): 35 mg LY3502970 Tablet (Fasted State)
Participants who completed Part A and received a QD oral dose of 35 mg LY3502970 tablet in fasted state from Day 78 to Day 84 are grouped under this arm.
OG011
Part B: Period 13 (Day 85-91): 35 mg LY3502970 Tablet (Fasted State)
Participants who completed Part A and received a QD oral dose of 35 mg LY3502970 tablet in fasted state from Day 85 to Day 91 are grouped under this arm.
OG012
Part B: Period 12 (Day 78-84): 45 mg LY3502970 Tablet (Fasted State)
Participants who completed Part A and received a QD oral dose of 45 mg LY3502970 tablet in fasted state from Day 78 to Day 84 are grouped under this arm.
OG013
Part B: Period 13 (Day 85-91): 60 mg LY3502970 Tablet (Fasted State)
Participants who completed Part A and received a QD oral dose of 60 mg LY3502970 tablet in fasted state from Day 85 to Day 91 are grouped under this arm.
OG014
Part B: Period 12 (Day 78-84): 36 mg LY3502970 DF Capsule (Fasted State)
Participants who completed Part A and received a QD oral dose of 36 mg LY3502970 DF capsule in fasted state from Day 78 to Day 84 are grouped under this arm.
OG015
Part B: Period 13 (Day 85-91): 36 mg LY3502970 EPB Capsule (Fasted State)
Participants who completed Part A and received a QD oral dose of 36 mg LY3502970 EPB capsule in fasted state from Day 85 to Day 91 are grouped under this arm.
Units
Counts
Participants
OG00050
OG00150
OG00250
OG003
Title
Denominators
Categories
Title
Measurements
OG0006.08± 26
OG00113.5± 39
OG00219.9± 34
OG003
Primary
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13
PK: Tmax of LY3502970 in fasted state
All enrolled participants who received at least one dose of study drug in Part A: periods 1-9, 11 and Part B: periods 12-13 (fasted state) and had evaluable PK data for this outcome.
Posted
Median
Full Range
hours
Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13
ID
Title
Description
OG000
Part A: Period 1 (Day 1-7): 0.8 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 0.8 mg LY3502970 tablet in fasted state from Day 1 to Day 7 are grouped under this arm.
OG001
Part A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State)
Participants who received a QD oral dose of 2 mg LY3502970 capsule in fasted state from Day 8 to Day 14 are grouped under this arm.
OG002
Part A: Period 3 (Day 15-21): 2.5 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 2.5 mg LY3502970 tablet in fasted state from Day 15 to Day 21 are grouped under this arm.
OG003
Part A: Period 4 (Day 22-28): 5 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 5 mg LY3502970 tablet in fasted state from Day 22 to Day 28 are grouped under this arm.
OG004
Part A: Period 5 (Day 29-35): 8 mg LY3502970 Capsule (Fasted State)
Participants who received a QD oral dose of 8 mg LY3502970 capsule in fasted state from Day 29 to Day 35 are grouped under this arm.
OG005
Part A: Period 6 (Day 36-42): 10 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 10 mg LY3502970 tablet in fasted state from Day 36 to Day 42 are grouped under this arm.
OG006
Part A: Period 7 (Day 43-49): 16 mg LY3502970 Capsule (Fasted State)
Participants who received a QD oral dose of 16 mg LY3502970 capsule in fasted state from Day 43 to Day 49 are grouped under this arm.
OG007
Part A: Period 8 (Day 50-56): 20 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 20 mg LY3502970 tablet in fasted state from Day 50 to Day 56 are grouped under this arm.
OG008
Part A: Period 9 (Day 57-63): 36 mg LY3502970 Capsule (Fasted State)
Participants who received a QD oral dose of 36 mg LY3502970 capsule in fasted state from Day 57 to Day 63 are grouped under this arm.
OG009
Part A: Period 11 (Day 71-77): 37.5 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 37.5 mg LY3502970 tablet in fasted state from Day 71 to Day 77 are grouped under this arm.
OG010
Part B: Period 12 (Day 78-84): 35 mg LY3502970 Tablet (Fasted State)
Participants who completed Part A and received a QD oral dose of 35 mg LY3502970 tablet in fasted state from Day 78 to Day 84 are grouped under this arm.
OG011
Part B: Period 13 (Day 85-91): 35 mg LY3502970 Tablet (Fasted State)
Participants who completed Part A and received a QD oral dose of 35 mg LY3502970 tablet in fasted state from Day 85 to Day 91 are grouped under this arm.
OG012
Part B: Period 12 (Day 78-84): 45 mg LY3502970 Tablet (Fasted State)
Participants who completed Part A and received a QD oral dose of 45 mg LY3502970 tablet in fasted state from Day 78 to Day 84 are grouped under this arm.
OG013
Part B: Period 13 (Day 85-91): 60 mg LY3502970 Tablet (Fasted State)
Participants who completed Part A and received a QD oral dose of 60 mg LY3502970 tablet in fasted state from Day 85 to Day 91 are grouped under this arm.
OG014
Part B: Period 12 (Day 78-84): 36 mg LY3502970 DF Capsule (Fasted State)
Participants who completed Part A and received a QD oral dose of 36 mg LY3502970 DF capsule in fasted state from Day 78 to Day 84 are grouped under this arm.
OG015
Part B: Period 13 (Day 85-91): 36 mg LY3502970 EPB Capsule (Fasted State)
Participants who completed Part A and received a QD oral dose of 36 mg LY3502970 EPB capsule in fasted state from Day 85 to Day 91 are grouped under this arm.
Units
Counts
Participants
OG00050
OG00150
OG00250
OG003
Title
Denominators
Categories
Title
Measurements
OG0006.00(3.98 to 8.00)
OG0016.00(0.00 to 12.00)
OG0026.00(2.00 to 8.02)
OG003
Secondary
PK: Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fed State - Part A: Period 10
PK: AUC[0-24] of LY3502970 in fed state
All enrolled participants who received at least one dose of study drug in Part A : Period 10 (fed state) and had evaluable PK data for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram*hour per milliliter (ng*h/mL)
Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)
ID
Title
Description
OG000
Part A: Period 10 (Day 64-70): 36 mg LY3502970 Capsule (Fed State)
Participants from Period 10 who received a QD oral dose of 36 mg LY3502970 capsule in fed state from Day 64 to Day 70 are grouped under this arm.
OG001
Part A: Period 10 (Day 64-70): 37.5 mg LY3502970 Tablet (Fed State)
Participants from Period 10 who received a QD oral dose of 37.5 mg LY3502970 tablet in fed state from Day 64 to Day 70 are grouped under this arm.
Units
Counts
Participants
OG00012
OG00117
Title
Denominators
Categories
Title
Measurements
OG0001230± 139
OG0013170± 36
Secondary
PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fed State - Part A: Period 10
PK: Cmax of LY3502970 in fed state
All enrolled participants who received at least one dose of study drug in Part A : Period 10 (fed state) and had evaluable PK data for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter (ng/mL)
Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)
ID
Title
Description
OG000
Part A: Period 10 (Day 64-70): 36 mg LY3502970 Capsule (Fed State)
Participants from Period 10 who received a QD oral dose of 36 mg LY3502970 capsule in fed state from Day 64 to Day 70 are grouped under this arm.
OG001
Part A: Period 10 (Day 64-70): 37.5 mg LY3502970 Tablet (Fed State)
Participants from Period 10 who received a QD oral dose of 37.5 mg LY3502970 tablet in fed state from Day 64 to Day 70 are grouped under this arm.
Units
Counts
Participants
OG00020
OG00121
Title
Denominators
Categories
Title
Measurements
OG00081.0± 104
OG001203± 51
Secondary
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fed State - Part A: Period 10
PK: Tmax of LY3502970 in fed state
All enrolled participants who received at least one dose of study drug in Part A : Period 10 (fed state) and had evaluable PK data for this outcome.
Posted
Median
Full Range
hours
Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)
ID
Title
Description
OG000
Part A: Period 10 (Day 64-70): 36 mg LY3502970 Capsule (Fed State)
Participants from Period 10 who received a QD oral dose of 36 mg LY3502970 capsule in fed state from Day 64 to Day 70 are grouped under this arm.
OG001
Part A: Period 10 (Day 64-70): 37.5 mg LY3502970 Tablet (Fed State)
Participants from Period 10 who received a QD oral dose of 37.5 mg LY3502970 tablet in fed state from Day 64 to Day 70 are grouped under this arm.
Units
Counts
Participants
OG00020
OG00121
Title
Denominators
Categories
Title
Measurements
OG00012.00(0.00 to 23.83)
OG0016.00(0.00 to 23.83)
0
52
0
52
7
52
EG001
Part A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State)
Participants who received a QD oral dose of 2 mg LY3502970 capsule in fasted state from Day 8 to Day 14 are grouped under this arm.
0
50
0
50
6
50
EG002
Part A: Period 3 (Day 15-21): 2.5 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 2.5 mg LY3502970 tablet in fasted state from Day 15 to Day 21 are grouped under this arm.
0
50
0
50
3
50
EG003
Part A: Period 4 (Day 22-28): 5 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 5 mg LY3502970 tablet in fasted state from Day 22 to Day 28 are grouped under this arm.
0
50
0
50
8
50
EG004
Part A: Period 5 (Day 29-35): 8 mg LY3502970 Capsule (Fasted State)
Participants who received a QD oral dose of 8 mg LY3502970 capsule in fasted state from Day 29 to Day 35 are grouped under this arm.
0
49
0
49
13
49
EG005
Part A: Period 6 (Day 36-42): 10 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 10 mg LY3502970 tablet in fasted state from Day 36 to Day 42 are grouped under this arm.
0
49
0
49
9
49
EG006
Part A: Period 7 (Day 43-49): 16 mg LY3502970 Capsule (Fasted State)
Participants who received a QD oral dose of 16 mg LY3502970 capsule in fasted state from Day 43 to Day 49 are grouped under this arm.
0
46
0
46
4
46
EG007
Part A: Period 8 (Day 50-56): 20 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 20 mg LY3502970 tablet in fasted state from Day 50 to Day 56 are grouped under this arm.
0
46
1
46
4
46
EG008
Part A: Period 9 (Day 57-63): 36 mg LY3502970 Capsule (Fasted State)
Participants who received a QD oral dose of 36 mg LY3502970 capsule in fasted state from Day 57 to Day 63 are grouped under this arm.
0
45
1
45
2
45
EG009
Part A: Period 10 (Day 64-70): 36 mg LY3502970 Capsule (Fed State)
Participants who received a QD oral dose of 36 mg LY3502970 capsule in fed state from Day 64 to Day 70 are grouped under this arm.
0
21
0
21
3
21
EG010
Part A: Period 10 (Day 64-70): 37.5 mg LY3502970 Tablet (Fed State)
Participants who received a QD oral dose of 37.5 mg LY3502970 tablet in fed state from Day 64 to Day 70 are grouped under this arm.
0
21
0
21
12
21
EG011
Part A: Period 11 (Day 71-77): 37.5 mg LY3502970 Tablet (Fasted State)
Participants who received a QD oral dose of 37.5 mg LY3502970 tablet in fasted state from Day 71 to Day 77 are grouped under this arm.
0
41
0
41
12
41
EG012
Part B: Period 12 (Day 78-84): 35 mg LY3502970 Tablet (Fasted State)
Participants who completed Part A and received a QD oral dose of 35 mg LY3502970 tablet in fasted state from Day 78 to Day 84 are grouped under this arm.
0
7
0
7
3
7
EG013
Part B: Period 13 (Day 85-91): 35 mg LY3502970 Tablet (Fasted State)
Participants who completed Part A and received a QD oral dose of 35 mg LY3502970 tablet in fasted state from Day 85 to Day 91 are grouped under this arm.
0
7
0
7
1
7
EG014
Part B: Period 12 (Day 78-84): 45 mg LY3502970 Tablet (Fasted State)
Participants who completed Part A and received a QD oral dose of 45 mg LY3502970 tablet in fasted state from Day 78 to Day 84 are grouped under this arm.
0
21
0
21
4
21
EG015
Part B: Period 13 (Day 85-91): 60 mg LY3502970 Tablet (Fasted State)
Participants who completed Part A and received a QD oral dose of 60 mg LY3502970 tablet in fasted state from Day 85 to Day 91 are grouped under this arm.
0
21
0
21
5
21
EG016
Part B: Period 12 (Day 78-84): 36 mg LY3502970 DF Capsule (Fasted State)
Participants who completed Part A and received a QD oral dose of 36 mg LY3502970 DF capsule in fasted state from Day 78 to Day 84 are grouped under this arm.
0
12
0
12
3
12
EG017
Part B: Period 13 (Day 85-91): 36 mg LY3502970 EPB Capsule (Fasted State)
Participants who completed Part A and received a QD oral dose of 36 mg LY3502970 EPB capsule in fasted state from Day 85 to Day 91 are grouped under this arm.