Trial Outcomes & Findings for A Multiple Dose Study of LY3502970 in Healthy Overweight and Obese Participants (NCT NCT05841238)
NCT ID: NCT05841238
Last Updated: 2026-07-10
Results Overview
PK: AUC\[0-24\] of LY3502970 in fasted state
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
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
Results posted on
2026-07-10
Participant Flow
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.
Participant milestones
| Measure |
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:
* Period 1 (Day 1-7): 0.8 milligram (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)
|
Part B: 35 mg LY3502970 / 35 mg LY3502970 (Periods 12 to 13)
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)
|
Part B: 45 mg LY3502970 / 60 mg LY3502970 (Periods 12 to 13)
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)
|
Part B: 36 mg LY3502970 DF / 36 mg LY3502970 EPB (Periods 12 to 13)
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): 36 mg LY3502970 dual-fill (DF) capsule (fasted state)
* Period 13 (Day 85-91): 36 mg LY3502970 extemporaneously prepared blended (EPB) capsule (fasted state)
|
|---|---|---|---|---|
|
Period 1
NOT COMPLETED
|
2
|
0
|
0
|
0
|
|
Period 8
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Period 1
STARTED
|
52
|
0
|
0
|
0
|
|
Period 1
COMPLETED
|
50
|
0
|
0
|
0
|
|
Period 2 to Period 3
STARTED
|
50
|
0
|
0
|
0
|
|
Period 2 to Period 3
COMPLETED
|
50
|
0
|
0
|
0
|
|
Period 2 to Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
50
|
0
|
0
|
0
|
|
Period 4
COMPLETED
|
49
|
0
|
0
|
0
|
|
Period 4
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Period 5
STARTED
|
49
|
0
|
0
|
0
|
|
Period 5
COMPLETED
|
49
|
0
|
0
|
0
|
|
Period 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 6
STARTED
|
49
|
0
|
0
|
0
|
|
Period 6
COMPLETED
|
46
|
0
|
0
|
0
|
|
Period 6
NOT COMPLETED
|
3
|
0
|
0
|
0
|
|
Period 7
STARTED
|
46
|
0
|
0
|
0
|
|
Period 7
COMPLETED
|
46
|
0
|
0
|
0
|
|
Period 7
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 8
STARTED
|
46
|
0
|
0
|
0
|
|
Period 8
COMPLETED
|
45
|
0
|
0
|
0
|
|
Period 9
STARTED
|
45
|
0
|
0
|
0
|
|
Period 9
COMPLETED
|
42
|
0
|
0
|
0
|
|
Period 9
NOT COMPLETED
|
3
|
0
|
0
|
0
|
|
Period 10: 36 mg LY3502970 Capsule
STARTED
|
21
|
0
|
0
|
0
|
|
Period 10: 36 mg LY3502970 Capsule
COMPLETED
|
20
|
0
|
0
|
0
|
|
Period 10: 36 mg LY3502970 Capsule
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Period 10: 37.5 mg LY3502970 Tablet
STARTED
|
21
|
0
|
0
|
0
|
|
Period 10: 37.5 mg LY3502970 Tablet
COMPLETED
|
21
|
0
|
0
|
0
|
|
Period 10: 37.5 mg LY3502970 Tablet
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 11
STARTED
|
41
|
0
|
0
|
0
|
|
Period 11
COMPLETED
|
40
|
0
|
0
|
0
|
|
Period 11
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Periods 12 to 13
STARTED
|
0
|
7
|
21
|
12
|
|
Periods 12 to 13
COMPLETED
|
0
|
7
|
21
|
12
|
|
Periods 12 to 13
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
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:
* Period 1 (Day 1-7): 0.8 milligram (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)
|
Part B: 35 mg LY3502970 / 35 mg LY3502970 (Periods 12 to 13)
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)
|
Part B: 45 mg LY3502970 / 60 mg LY3502970 (Periods 12 to 13)
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)
|
Part B: 36 mg LY3502970 DF / 36 mg LY3502970 EPB (Periods 12 to 13)
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): 36 mg LY3502970 dual-fill (DF) capsule (fasted state)
* Period 13 (Day 85-91): 36 mg LY3502970 extemporaneously prepared blended (EPB) capsule (fasted state)
|
|---|---|---|---|---|
|
Period 1
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
|
Period 4
Adverse Event
|
1
|
0
|
0
|
0
|
|
Period 6
Physician Decision
|
1
|
0
|
0
|
0
|
|
Period 6
Use of Prohibited Concomitant Medication
|
1
|
0
|
0
|
0
|
|
Period 6
Non-compliance with Study Requirements
|
1
|
0
|
0
|
0
|
|
Period 8
Adverse Event
|
1
|
0
|
0
|
0
|
|
Period 9
Adverse Event
|
3
|
0
|
0
|
0
|
|
Period 10: 36 mg LY3502970 Capsule
Protocol deviation
|
1
|
0
|
0
|
0
|
|
Period 11
Adverse Event
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Multiple Dose Study of LY3502970 in Healthy Overweight and Obese Participants
Baseline characteristics by cohort
| Measure |
Part A: LY3502970 (Periods 1 to 11)
n=52 Participants
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)
|
|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 11.9 • n=9 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
52 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 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 12-13Population: 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.
PK: AUC\[0-24\] of LY3502970 in fasted state
Outcome measures
| Measure |
Part A: Period 1 (Day 1-7): 0.8 mg LY3502970 Tablet (Fasted State)
n=50 Participants
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 A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State)
n=50 Participants
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.
|
Part A: Period 3 (Day 15-21): 2.5 mg LY3502970 Tablet (Fasted State)
n=50 Participants
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.
|
Part A: Period 4 (Day 22-28): 5 mg LY3502970 Tablet (Fasted State)
n=47 Participants
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.
|
Part A: Period 5 (Day 29-35): 8 mg LY3502970 Capsule (Fasted State)
n=49 Participants
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.
|
Part A: Period 6 (Day 36-42): 10 mg LY3502970 Tablet (Fasted State)
n=46 Participants
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.
|
Part A: Period 7 (Day 43-49): 16 mg LY3502970 Capsule (Fasted State)
n=41 Participants
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.
|
Part A: Period 8 (Day 50-56): 20 mg LY3502970 Tablet (Fasted State)
n=44 Participants
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.
|
Part A: Period 9 (Day 57-63): 36 mg LY3502970 Capsule (Fasted State)
n=43 Participants
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.
|
Part A: Period 11 (Day 71-77): 37.5 mg LY3502970 Tablet (Fasted State)
n=40 Participants
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.
|
Part B: Period 12 (Day 78-84): 35 mg LY3502970 Tablet (Fasted State)
n=7 Participants
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.
|
Part B: Period 13 (Day 85-91): 35 mg LY3502970 Tablet (Fasted State)
n=7 Participants
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.
|
Part B: Period 12 (Day 78-84): 45 mg LY3502970 Tablet (Fasted State)
n=20 Participants
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.
|
Part B: Period 13 (Day 85-91): 60 mg LY3502970 Tablet (Fasted State)
n=21 Participants
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.
|
Part B: Period 12 (Day 78-84): 36 mg LY3502970 DF Capsule (Fasted State)
n=12 Participants
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.
|
Part B: Period 13 (Day 85-91): 36 mg LY3502970 EPB Capsule (Fasted State)
n=12 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
90.8 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 27
|
199 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 34
|
294 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 31
|
548 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 29
|
700 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 42
|
1080 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 32
|
1250 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 40
|
1970 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 48
|
1580 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 72
|
3680 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 47
|
3730 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 37
|
4080 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 40
|
4100 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 51
|
6410 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 49
|
1950 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 59
|
3030 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 45
|
PRIMARY outcome
Timeframe: 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 12-13Population: 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.
PK: Cmax of LY3502970 in fasted state
Outcome measures
| Measure |
Part A: Period 1 (Day 1-7): 0.8 mg LY3502970 Tablet (Fasted State)
n=50 Participants
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 A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State)
n=50 Participants
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.
|
Part A: Period 3 (Day 15-21): 2.5 mg LY3502970 Tablet (Fasted State)
n=50 Participants
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.
|
Part A: Period 4 (Day 22-28): 5 mg LY3502970 Tablet (Fasted State)
n=49 Participants
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.
|
Part A: Period 5 (Day 29-35): 8 mg LY3502970 Capsule (Fasted State)
n=49 Participants
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.
|
Part A: Period 6 (Day 36-42): 10 mg LY3502970 Tablet (Fasted State)
n=46 Participants
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.
|
Part A: Period 7 (Day 43-49): 16 mg LY3502970 Capsule (Fasted State)
n=46 Participants
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.
|
Part A: Period 8 (Day 50-56): 20 mg LY3502970 Tablet (Fasted State)
n=45 Participants
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.
|
Part A: Period 9 (Day 57-63): 36 mg LY3502970 Capsule (Fasted State)
n=45 Participants
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.
|
Part A: Period 11 (Day 71-77): 37.5 mg LY3502970 Tablet (Fasted State)
n=40 Participants
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.
|
Part B: Period 12 (Day 78-84): 35 mg LY3502970 Tablet (Fasted State)
n=7 Participants
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.
|
Part B: Period 13 (Day 85-91): 35 mg LY3502970 Tablet (Fasted State)
n=7 Participants
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.
|
Part B: Period 12 (Day 78-84): 45 mg LY3502970 Tablet (Fasted State)
n=21 Participants
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.
|
Part B: Period 13 (Day 85-91): 60 mg LY3502970 Tablet (Fasted State)
n=21 Participants
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.
|
Part B: Period 12 (Day 78-84): 36 mg LY3502970 DF Capsule (Fasted State)
n=12 Participants
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.
|
Part B: Period 13 (Day 85-91): 36 mg LY3502970 EPB Capsule (Fasted State)
n=12 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13
|
6.08 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 26
|
13.5 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 39
|
19.9 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 34
|
36.6 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
45.1 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 49
|
69.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 34
|
73.5 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 58
|
126 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 57
|
100 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 89
|
257 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 54
|
234 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 39
|
295 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 39
|
275 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 49
|
460 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 55
|
109 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 58
|
203 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 48
|
PRIMARY outcome
Timeframe: 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 12-13Population: 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.
PK: Tmax of LY3502970 in fasted state
Outcome measures
| Measure |
Part A: Period 1 (Day 1-7): 0.8 mg LY3502970 Tablet (Fasted State)
n=50 Participants
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 A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State)
n=50 Participants
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.
|
Part A: Period 3 (Day 15-21): 2.5 mg LY3502970 Tablet (Fasted State)
n=50 Participants
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.
|
Part A: Period 4 (Day 22-28): 5 mg LY3502970 Tablet (Fasted State)
n=49 Participants
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.
|
Part A: Period 5 (Day 29-35): 8 mg LY3502970 Capsule (Fasted State)
n=49 Participants
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.
|
Part A: Period 6 (Day 36-42): 10 mg LY3502970 Tablet (Fasted State)
n=46 Participants
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.
|
Part A: Period 7 (Day 43-49): 16 mg LY3502970 Capsule (Fasted State)
n=46 Participants
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.
|
Part A: Period 8 (Day 50-56): 20 mg LY3502970 Tablet (Fasted State)
n=45 Participants
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.
|
Part A: Period 9 (Day 57-63): 36 mg LY3502970 Capsule (Fasted State)
n=45 Participants
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.
|
Part A: Period 11 (Day 71-77): 37.5 mg LY3502970 Tablet (Fasted State)
n=40 Participants
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.
|
Part B: Period 12 (Day 78-84): 35 mg LY3502970 Tablet (Fasted State)
n=7 Participants
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.
|
Part B: Period 13 (Day 85-91): 35 mg LY3502970 Tablet (Fasted State)
n=7 Participants
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.
|
Part B: Period 12 (Day 78-84): 45 mg LY3502970 Tablet (Fasted State)
n=21 Participants
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.
|
Part B: Period 13 (Day 85-91): 60 mg LY3502970 Tablet (Fasted State)
n=21 Participants
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.
|
Part B: Period 12 (Day 78-84): 36 mg LY3502970 DF Capsule (Fasted State)
n=12 Participants
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.
|
Part B: Period 13 (Day 85-91): 36 mg LY3502970 EPB Capsule (Fasted State)
n=12 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13
|
6.00 hours
Interval 3.98 to 8.0
|
6.00 hours
Interval 0.0 to 12.0
|
6.00 hours
Interval 2.0 to 8.02
|
6.00 hours
Interval 2.0 to 23.83
|
8.00 hours
Interval 1.0 to 12.0
|
6.00 hours
Interval 0.0 to 12.0
|
6.00 hours
Interval 0.0 to 23.83
|
8.00 hours
Interval 0.0 to 23.83
|
8.00 hours
Interval 2.0 to 23.87
|
6.03 hours
Interval 1.0 to 12.0
|
8.00 hours
Interval 4.0 to 12.0
|
4.03 hours
Interval 4.0 to 8.0
|
4.07 hours
Interval 2.07 to 8.0
|
8.00 hours
Interval 2.0 to 12.0
|
5.92 hours
Interval 1.92 to 7.92
|
6.88 hours
Interval 1.92 to 7.93
|
SECONDARY outcome
Timeframe: 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)Population: 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.
PK: AUC\[0-24\] of LY3502970 in fed state
Outcome measures
| Measure |
Part A: Period 1 (Day 1-7): 0.8 mg LY3502970 Tablet (Fasted State)
n=12 Participants
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 A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State)
n=17 Participants
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
1230 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 139
|
3170 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 36
|
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—
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SECONDARY outcome
Timeframe: 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)Population: 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.
PK: Cmax of LY3502970 in fed state
Outcome measures
| Measure |
Part A: Period 1 (Day 1-7): 0.8 mg LY3502970 Tablet (Fasted State)
n=20 Participants
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 A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State)
n=21 Participants
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fed State - Part A: Period 10
|
81.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 104
|
203 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 51
|
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SECONDARY outcome
Timeframe: 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)Population: 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.
PK: Tmax of LY3502970 in fed state
Outcome measures
| Measure |
Part A: Period 1 (Day 1-7): 0.8 mg LY3502970 Tablet (Fasted State)
n=20 Participants
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 A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State)
n=21 Participants
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fed State - Part A: Period 10
|
12.00 hours
Interval 0.0 to 23.83
|
6.00 hours
Interval 0.0 to 23.83
|
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Adverse Events
Part A: Period 1 (Day 1-7): 0.8 mg LY3502970 Tablet (Fasted State)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A: Period 3 (Day 15-21): 2.5 mg LY3502970 Tablet (Fasted State)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: Period 4 (Day 22-28): 5 mg LY3502970 Tablet (Fasted State)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part A: Period 5 (Day 29-35): 8 mg LY3502970 Capsule (Fasted State)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Part A: Period 6 (Day 36-42): 10 mg LY3502970 Tablet (Fasted State)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part A: Period 7 (Day 43-49): 16 mg LY3502970 Capsule (Fasted State)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A: Period 8 (Day 50-56): 20 mg LY3502970 Tablet (Fasted State)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A: Period 9 (Day 57-63): 36 mg LY3502970 Capsule (Fasted State)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: Period 10 (Day 64-70): 36 mg LY3502970 Capsule (Fed State)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: Period 10 (Day 64-70): 37.5 mg LY3502970 Tablet (Fed State)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Part A: Period 11 (Day 71-77): 37.5 mg LY3502970 Tablet (Fasted State)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Part B: Period 12 (Day 78-84): 35 mg LY3502970 Tablet (Fasted State)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B: Period 13 (Day 85-91): 35 mg LY3502970 Tablet (Fasted State)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: Period 12 (Day 78-84): 45 mg LY3502970 Tablet (Fasted State)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B: Period 13 (Day 85-91): 60 mg LY3502970 Tablet (Fasted State)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B: Period 12 (Day 78-84): 36 mg LY3502970 DF Capsule (Fasted State)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B: Period 13 (Day 85-91): 36 mg LY3502970 EPB Capsule (Fasted State)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: Period 1 (Day 1-7): 0.8 mg LY3502970 Tablet (Fasted State)
n=52 participants at risk
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 A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State)
n=50 participants at risk
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.
|
Part A: Period 3 (Day 15-21): 2.5 mg LY3502970 Tablet (Fasted State)
n=50 participants at risk
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.
|
Part A: Period 4 (Day 22-28): 5 mg LY3502970 Tablet (Fasted State)
n=50 participants at risk
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.
|
Part A: Period 5 (Day 29-35): 8 mg LY3502970 Capsule (Fasted State)
n=49 participants at risk
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.
|
Part A: Period 6 (Day 36-42): 10 mg LY3502970 Tablet (Fasted State)
n=49 participants at risk
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.
|
Part A: Period 7 (Day 43-49): 16 mg LY3502970 Capsule (Fasted State)
n=46 participants at risk
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.
|
Part A: Period 8 (Day 50-56): 20 mg LY3502970 Tablet (Fasted State)
n=46 participants at risk
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.
|
Part A: Period 9 (Day 57-63): 36 mg LY3502970 Capsule (Fasted State)
n=45 participants at risk
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.
|
Part A: Period 10 (Day 64-70): 36 mg LY3502970 Capsule (Fed State)
n=21 participants at risk
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.
|
Part A: Period 10 (Day 64-70): 37.5 mg LY3502970 Tablet (Fed State)
n=21 participants at risk
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.
|
Part A: Period 11 (Day 71-77): 37.5 mg LY3502970 Tablet (Fasted State)
n=41 participants at risk
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.
|
Part B: Period 12 (Day 78-84): 35 mg LY3502970 Tablet (Fasted State)
n=7 participants at risk
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.
|
Part B: Period 13 (Day 85-91): 35 mg LY3502970 Tablet (Fasted State)
n=7 participants at risk
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.
|
Part B: Period 12 (Day 78-84): 45 mg LY3502970 Tablet (Fasted State)
n=21 participants at risk
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.
|
Part B: Period 13 (Day 85-91): 60 mg LY3502970 Tablet (Fasted State)
n=21 participants at risk
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.
|
Part B: Period 12 (Day 78-84): 36 mg LY3502970 DF Capsule (Fasted State)
n=12 participants at risk
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.
|
Part B: Period 13 (Day 85-91): 36 mg LY3502970 EPB Capsule (Fasted State)
n=12 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/52 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/49 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/49 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/46 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/46 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.2%
1/45 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/41 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/12 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/12 • Baseline to end of follow-up (up to 15 weeks)
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.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/52 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/49 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/49 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/46 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.2%
1/46 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/45 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/41 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/12 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/12 • Baseline to end of follow-up (up to 15 weeks)
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.
|
Other adverse events
| Measure |
Part A: Period 1 (Day 1-7): 0.8 mg LY3502970 Tablet (Fasted State)
n=52 participants at risk
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 A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State)
n=50 participants at risk
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.
|
Part A: Period 3 (Day 15-21): 2.5 mg LY3502970 Tablet (Fasted State)
n=50 participants at risk
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.
|
Part A: Period 4 (Day 22-28): 5 mg LY3502970 Tablet (Fasted State)
n=50 participants at risk
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.
|
Part A: Period 5 (Day 29-35): 8 mg LY3502970 Capsule (Fasted State)
n=49 participants at risk
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.
|
Part A: Period 6 (Day 36-42): 10 mg LY3502970 Tablet (Fasted State)
n=49 participants at risk
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.
|
Part A: Period 7 (Day 43-49): 16 mg LY3502970 Capsule (Fasted State)
n=46 participants at risk
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.
|
Part A: Period 8 (Day 50-56): 20 mg LY3502970 Tablet (Fasted State)
n=46 participants at risk
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.
|
Part A: Period 9 (Day 57-63): 36 mg LY3502970 Capsule (Fasted State)
n=45 participants at risk
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.
|
Part A: Period 10 (Day 64-70): 36 mg LY3502970 Capsule (Fed State)
n=21 participants at risk
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.
|
Part A: Period 10 (Day 64-70): 37.5 mg LY3502970 Tablet (Fed State)
n=21 participants at risk
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.
|
Part A: Period 11 (Day 71-77): 37.5 mg LY3502970 Tablet (Fasted State)
n=41 participants at risk
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.
|
Part B: Period 12 (Day 78-84): 35 mg LY3502970 Tablet (Fasted State)
n=7 participants at risk
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.
|
Part B: Period 13 (Day 85-91): 35 mg LY3502970 Tablet (Fasted State)
n=7 participants at risk
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.
|
Part B: Period 12 (Day 78-84): 45 mg LY3502970 Tablet (Fasted State)
n=21 participants at risk
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.
|
Part B: Period 13 (Day 85-91): 60 mg LY3502970 Tablet (Fasted State)
n=21 participants at risk
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.
|
Part B: Period 12 (Day 78-84): 36 mg LY3502970 DF Capsule (Fasted State)
n=12 participants at risk
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.
|
Part B: Period 13 (Day 85-91): 36 mg LY3502970 EPB Capsule (Fasted State)
n=12 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/52 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.1%
2/49 • Number of events 2 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/49 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/46 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/46 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/45 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.8%
1/21 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.4%
1/41 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
9.5%
2/21 • Number of events 2 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/12 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/12 • Baseline to end of follow-up (up to 15 weeks)
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/52 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.0%
1/50 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/49 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/49 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/46 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.2%
1/46 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.2%
1/45 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.8%
1/21 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.8%
1/21 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
7.3%
3/41 • Number of events 3 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/12 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/12 • Baseline to end of follow-up (up to 15 weeks)
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.
|
|
Gastrointestinal disorders
Constipation
|
3.8%
2/52 • Number of events 2 • Baseline to end of follow-up (up to 15 weeks)
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.
|
10.0%
5/50 • Number of events 5 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.0%
1/50 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.1%
2/49 • Number of events 2 • Baseline to end of follow-up (up to 15 weeks)
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.
|
12.2%
6/49 • Number of events 6 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/46 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/46 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/45 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.8%
1/21 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
9.5%
2/21 • Number of events 2 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/41 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.8%
1/21 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
8.3%
1/12 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/12 • Baseline to end of follow-up (up to 15 weeks)
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/52 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.0%
1/50 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
6.1%
3/49 • Number of events 3 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/49 • Baseline to end of follow-up (up to 15 weeks)
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.
|
6.5%
3/46 • Number of events 3 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.2%
1/46 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.4%
2/45 • Number of events 2 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.8%
1/21 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.4%
1/41 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
8.3%
1/12 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
8.3%
1/12 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
1/52 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.0%
2/50 • Number of events 2 • Baseline to end of follow-up (up to 15 weeks)
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.
|
10.2%
5/49 • Number of events 5 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.0%
1/49 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/46 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.3%
2/46 • Number of events 2 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/45 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
9.5%
2/21 • Number of events 2 • Baseline to end of follow-up (up to 15 weeks)
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.
|
7.3%
3/41 • Number of events 3 • Baseline to end of follow-up (up to 15 weeks)
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.
|
14.3%
1/7 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.8%
1/21 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/12 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/12 • Baseline to end of follow-up (up to 15 weeks)
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.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/52 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/49 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/49 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/46 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/46 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/45 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/41 • Baseline to end of follow-up (up to 15 weeks)
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.
|
14.3%
1/7 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/12 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/12 • Baseline to end of follow-up (up to 15 weeks)
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.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/52 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.0%
1/50 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.0%
1/49 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.0%
1/49 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/46 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/46 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/45 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.8%
1/21 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/41 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/12 • Baseline to end of follow-up (up to 15 weeks)
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.
|
8.3%
1/12 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
2/52 • Number of events 2 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.0%
1/49 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.1%
2/49 • Number of events 2 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/46 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.2%
1/46 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/45 • Baseline to end of follow-up (up to 15 weeks)
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.
|
9.5%
2/21 • Number of events 2 • Baseline to end of follow-up (up to 15 weeks)
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.
|
19.0%
4/21 • Number of events 4 • Baseline to end of follow-up (up to 15 weeks)
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.
|
14.6%
6/41 • Number of events 6 • Baseline to end of follow-up (up to 15 weeks)
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.
|
14.3%
1/7 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
9.5%
2/21 • Number of events 2 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.8%
1/21 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
8.3%
1/12 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
41.7%
5/12 • Number of events 5 • Baseline to end of follow-up (up to 15 weeks)
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.
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
2/52 • Number of events 2 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.0%
1/50 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.1%
2/49 • Number of events 2 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/49 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.2%
1/46 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.2%
1/46 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/45 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.8%
1/21 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
12.2%
5/41 • Number of events 6 • Baseline to end of follow-up (up to 15 weeks)
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.
|
14.3%
1/7 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.8%
1/21 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
14.3%
3/21 • Number of events 3 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/12 • Baseline to end of follow-up (up to 15 weeks)
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.
|
8.3%
1/12 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/52 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.0%
1/50 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
6.1%
3/49 • Number of events 3 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/49 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/46 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/46 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/45 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.4%
1/41 • Number of events 2 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/12 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/12 • Baseline to end of follow-up (up to 15 weeks)
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.
|
|
Nervous system disorders
Headache
|
3.8%
2/52 • Number of events 2 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.0%
2/50 • Number of events 2 • Baseline to end of follow-up (up to 15 weeks)
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.
|
12.0%
6/50 • Number of events 6 • Baseline to end of follow-up (up to 15 weeks)
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.
|
2.0%
1/49 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/49 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/46 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/46 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/45 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
19.0%
4/21 • Number of events 4 • Baseline to end of follow-up (up to 15 weeks)
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.
|
12.2%
5/41 • Number of events 7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.8%
1/21 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/12 • Baseline to end of follow-up (up to 15 weeks)
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.
|
16.7%
2/12 • Number of events 2 • Baseline to end of follow-up (up to 15 weeks)
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.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/52 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/50 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/49 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/49 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/46 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/46 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/45 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
4.8%
1/21 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/41 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/7 • Baseline to end of follow-up (up to 15 weeks)
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.
|
14.3%
1/7 • Number of events 1 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/21 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/12 • Baseline to end of follow-up (up to 15 weeks)
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.
|
0.00%
0/12 • Baseline to end of follow-up (up to 15 weeks)
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60