Trial Outcomes & Findings for A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus (NCT NCT05048719)
NCT ID: NCT05048719
Last Updated: 2023-10-17
Results Overview
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
383 participants
Primary outcome timeframe
Baseline, Week 26
Results posted on
2023-10-17
Participant Flow
For maintenance doses of LY3502970: 3, 12, 24, 36, and 45 milligrams (mg), the initial dose will be 2 or 3 mg followed by additional escalation steps as appropriate. The dose escalation varied by dose group where the target maintenance dose was achieved between Weeks 4 and 12.
Participant milestones
| Measure |
Placebo
Participants received matching placebo.
|
3 mg LY3502970
Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD).
|
12 mg LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
|
24 mg LY3502970
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
|
36 mg LY3502970 - 1
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.
|
36 mg LY3502970 - 2
Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.
|
45 mg LY3502970 - 1
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.
|
45 mg LY3502970 - 2
Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.
|
1.5 mg Dulaglutide
Participants received 1.5 mg Dulaglutide administered subcutaneously (SC) once weekly (QW).
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
55
|
51
|
56
|
47
|
27
|
34
|
31
|
32
|
50
|
|
Overall Study
Received At Least One Dose of Study Drug
|
55
|
51
|
56
|
47
|
27
|
34
|
31
|
32
|
50
|
|
Overall Study
COMPLETED
|
51
|
47
|
50
|
42
|
25
|
30
|
29
|
29
|
49
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
6
|
5
|
2
|
4
|
2
|
3
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants received matching placebo.
|
3 mg LY3502970
Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD).
|
12 mg LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
|
24 mg LY3502970
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
|
36 mg LY3502970 - 1
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.
|
36 mg LY3502970 - 2
Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.
|
45 mg LY3502970 - 1
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.
|
45 mg LY3502970 - 2
Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.
|
1.5 mg Dulaglutide
Participants received 1.5 mg Dulaglutide administered subcutaneously (SC) once weekly (QW).
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
3
|
1
|
0
|
2
|
1
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
3
|
1
|
1
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Patient Decision due To Changes in Personal Life
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Participant was Unresponsive and Too Far Out of Window to Resume Treatment
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Sponsor decision due To inadvertent Enrollment
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Participant decided to Discontinue Treatment and only Return for Single Final Visit
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Site Terminated Participant due to Sponsor Directions
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo
n=55 Participants
Participants received matching placebo.
|
3 mg LY3502970
n=51 Participants
Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally QD.
|
12 mg LY3502970
n=56 Participants
Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
|
24 mg LY3502970
n=47 Participants
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
|
36 mg LY3502970 - 1
n=27 Participants
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.
|
36 mg LY3502970 - 2
n=34 Participants
Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.
|
45 mg LY3502970 - 1
n=31 Participants
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.
|
45 mg LY3502970 - 2
n=32 Participants
Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.
|
1.5 mg Dulaglutide
n=50 Participants
Participants received 1.5 mg Dulaglutide administered SC QW.
|
Total
n=383 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.30 years
STANDARD_DEVIATION 9.52 • n=93 Participants
|
59.00 years
STANDARD_DEVIATION 9.43 • n=4 Participants
|
57.40 years
STANDARD_DEVIATION 9.23 • n=27 Participants
|
60.50 years
STANDARD_DEVIATION 9.11 • n=483 Participants
|
59.20 years
STANDARD_DEVIATION 9.07 • n=36 Participants
|
60.10 years
STANDARD_DEVIATION 9.37 • n=10 Participants
|
58.10 years
STANDARD_DEVIATION 10.63 • n=115 Participants
|
58.90 years
STANDARD_DEVIATION 8.18 • n=40 Participants
|
58.80 years
STANDARD_DEVIATION 10.19 • n=8 Participants
|
58.90 years
STANDARD_DEVIATION 9.40 • n=62 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
16 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
13 Participants
n=40 Participants
|
20 Participants
n=8 Participants
|
157 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
18 Participants
n=36 Participants
|
18 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
19 Participants
n=40 Participants
|
30 Participants
n=8 Participants
|
226 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
7 Participants
n=8 Participants
|
74 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
42 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
27 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
26 Participants
n=40 Participants
|
43 Participants
n=8 Participants
|
309 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
22 Participants
n=62 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
43 Participants
n=483 Participants
|
25 Participants
n=36 Participants
|
33 Participants
n=10 Participants
|
29 Participants
n=115 Participants
|
28 Participants
n=40 Participants
|
44 Participants
n=8 Participants
|
348 Participants
n=62 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
|
Region of Enrollment
Hungary
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
9 Participants
n=8 Participants
|
63 Participants
n=62 Participants
|
|
Region of Enrollment
Poland
|
11 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
9 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
12 Participants
n=8 Participants
|
85 Participants
n=62 Participants
|
|
Region of Enrollment
Slovakia
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
7 Participants
n=8 Participants
|
65 Participants
n=62 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
14 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
16 Participants
n=40 Participants
|
22 Participants
n=8 Participants
|
170 Participants
n=62 Participants
|
|
Hemoglobin A1c (HbA1c)
|
8.1 Percentage of HbA1c
STANDARD_DEVIATION 0.9 • n=93 Participants
|
8.0 Percentage of HbA1c
STANDARD_DEVIATION 0.8 • n=4 Participants
|
8.2 Percentage of HbA1c
STANDARD_DEVIATION 0.9 • n=27 Participants
|
8.2 Percentage of HbA1c
STANDARD_DEVIATION 0.9 • n=483 Participants
|
8.0 Percentage of HbA1c
STANDARD_DEVIATION 0.7 • n=36 Participants
|
8.1 Percentage of HbA1c
STANDARD_DEVIATION 0.8 • n=10 Participants
|
8.3 Percentage of HbA1c
STANDARD_DEVIATION 1.0 • n=115 Participants
|
8.0 Percentage of HbA1c
STANDARD_DEVIATION 0.8 • n=40 Participants
|
8.0 Percentage of HbA1c
STANDARD_DEVIATION 0.7 • n=8 Participants
|
8.1 Percentage of HbA1c
STANDARD_DEVIATION 0.8 • n=62 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 26Population: All participants who received at least one dose of LY3502970 or placebo and had baseline and at least one post-baseline value for HbA1c.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
3 mg LY3502970
n=46 Participants
Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily QD.
|
12 mg LY3502970
n=49 Participants
Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
|
24 mg LY3502970
n=42 Participants
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
|
36 mg LY3502970
n=57 Participants
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally QD.
|
45 mg LY3502970
n=58 Participants
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally QD.
|
Placebo
n=55 Participants
Participants received matching placebo.
|
1.5 mg Dulaglutide
Participants received 1.5 mg Dulaglutide administered SC QW.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in HbA1c in LY3502970 as Compared to Placebo
|
-1.19 Percentage of HbA1c
Standard Error 0.137
|
-1.91 Percentage of HbA1c
Standard Error 0.133
|
-1.79 Percentage of HbA1c
Standard Error 0.149
|
-2.03 Percentage of HbA1c
Standard Error 0.127
|
-2.10 Percentage of HbA1c
Standard Error 0.124
|
-0.43 Percentage of HbA1c
Standard Error 0.128
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All participants who received at least one dose of LY3502970 or dulaglutide, had a baseline, and at least one post-baseline value for HbA1c.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
3 mg LY3502970
n=46 Participants
Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily QD.
|
12 mg LY3502970
n=49 Participants
Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
|
24 mg LY3502970
n=42 Participants
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
|
36 mg LY3502970
n=57 Participants
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally QD.
|
45 mg LY3502970
n=58 Participants
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally QD.
|
Placebo
n=49 Participants
Participants received matching placebo.
|
1.5 mg Dulaglutide
Participants received 1.5 mg Dulaglutide administered SC QW.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide
|
-1.19 Percentage of HbA1c
Standard Error 0.137
|
-1.91 Percentage of HbA1c
Standard Error 0.133
|
-1.79 Percentage of HbA1c
Standard Error 0.149
|
-2.03 Percentage of HbA1c
Standard Error 0.127
|
-2.10 Percentage of HbA1c
Standard Error 0.124
|
-1.10 Percentage of HbA1c
Standard Error 0.131
|
—
|
SECONDARY outcome
Timeframe: Week 26Population: All participants who received at least one dose of study drug, had a baseline and at least one post-baseline HbA1c value.
Percentage of Participants with HbA1c ≤ 6.5%. Odds ratio was calculated using logistic regression model.
Outcome measures
| Measure |
3 mg LY3502970
n=46 Participants
Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily QD.
|
12 mg LY3502970
n=49 Participants
Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
|
24 mg LY3502970
n=42 Participants
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
|
36 mg LY3502970
n=57 Participants
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally QD.
|
45 mg LY3502970
n=58 Participants
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally QD.
|
Placebo
n=22 Participants
Participants received matching placebo.
|
1.5 mg Dulaglutide
n=49 Participants
Participants received 1.5 mg Dulaglutide administered SC QW.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HbA1c ≤ 6.5%
|
45.30 Percentage of participants
|
70.73 Percentage of participants
|
80.12 Percentage of participants
|
79.39 Percentage of participants
|
83.52 Percentage of participants
|
14.56 Percentage of participants
|
41.04 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: All participants who received at least one dose of study drug, had a baseline and at least one post-baseline HbA1c value.
Percentage of Participants with HbA1c \<7.0%. Odds ratio was calculated using logistic regression model.
Outcome measures
| Measure |
3 mg LY3502970
n=46 Participants
Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily QD.
|
12 mg LY3502970
n=49 Participants
Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
|
24 mg LY3502970
n=42 Participants
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
|
36 mg LY3502970
n=57 Participants
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally QD.
|
45 mg LY3502970
n=58 Participants
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally QD.
|
Placebo
n=55 Participants
Participants received matching placebo.
|
1.5 mg Dulaglutide
n=49 Participants
Participants received 1.5 mg Dulaglutide administered SC QW.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HbA1c <7.0%
|
65.17 Percentage of participants
|
78.92 Percentage of participants
|
91.24 Percentage of participants
|
92.75 Percentage of participants
|
95.76 Percentage of participants
|
24.27 Percentage of participants
|
64.06 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All participants who received at least one dose of study drug, had baseline and at least one post-baseline fasting glucose data.
Fasting glucose is a test to determine sugar levels in blood sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, 8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
3 mg LY3502970
n=46 Participants
Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily QD.
|
12 mg LY3502970
n=49 Participants
Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
|
24 mg LY3502970
n=42 Participants
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
|
36 mg LY3502970
n=57 Participants
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally QD.
|
45 mg LY3502970
n=58 Participants
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally QD.
|
Placebo
n=55 Participants
Participants received matching placebo.
|
1.5 mg Dulaglutide
n=49 Participants
Participants received 1.5 mg Dulaglutide administered SC QW.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Serum Glucose
|
-32.6 milligrams per deciliter (mg/dL)
Standard Error 4.14
|
-53.7 milligrams per deciliter (mg/dL)
Standard Error 3.92
|
-52.2 milligrams per deciliter (mg/dL)
Standard Error 4.49
|
-53.9 milligrams per deciliter (mg/dL)
Standard Error 3.79
|
-55.9 milligrams per deciliter (mg/dL)
Standard Error 3.69
|
-11.1 milligrams per deciliter (mg/dL)
Standard Error 3.90
|
-33.2 milligrams per deciliter (mg/dL)
Standard Error 3.91
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All participants who received at least one dose of study drug, had baseline and at least one post-baseline body weight data.
LS mean was determined by MMRM model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
3 mg LY3502970
n=50 Participants
Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily QD.
|
12 mg LY3502970
n=53 Participants
Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
|
24 mg LY3502970
n=46 Participants
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
|
36 mg LY3502970
n=57 Participants
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally QD.
|
45 mg LY3502970
n=62 Participants
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally QD.
|
Placebo
n=55 Participants
Participants received matching placebo.
|
1.5 mg Dulaglutide
n=50 Participants
Participants received 1.5 mg Dulaglutide administered SC QW.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight
|
-3.7 kilograms (kg)
Standard Error 0.79
|
-6.5 kilograms (kg)
Standard Error 0.76
|
-9.7 kilograms (kg)
Standard Error 0.85
|
-9.5 kilograms (kg)
Standard Error 0.73
|
-10.1 kilograms (kg)
Standard Error 0.71
|
-2.2 kilograms (kg)
Standard Error 0.74
|
-3.9 kilograms (kg)
Standard Error 0.76
|
SECONDARY outcome
Timeframe: Pre-dose (Week (wk) 0, wk 8, wk 12, and wk 26); Post-dose (wk 4, wk 8, wk 16, wk 20, and end of treatment).Population: All participants who received at least one dose of LY3502970 and had evaluable PK data.
PK: Steady State AUC of LY3502970
Outcome measures
| Measure |
3 mg LY3502970
n=45 Participants
Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily QD.
|
12 mg LY3502970
n=48 Participants
Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
|
24 mg LY3502970
n=43 Participants
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
|
36 mg LY3502970
n=24 Participants
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally QD.
|
45 mg LY3502970
n=29 Participants
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally QD.
|
Placebo
n=25 Participants
Participants received matching placebo.
|
1.5 mg Dulaglutide
n=28 Participants
Participants received 1.5 mg Dulaglutide administered SC QW.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970
|
364 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 38.7
|
1020 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 63.5
|
1500 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 84.5
|
1830 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 94.6
|
2430 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 39.8
|
2230 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 80.4
|
2550 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 55.3
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 25 other events
Deaths: 1 deaths
3 mg LY3502970
Serious events: 3 serious events
Other events: 34 other events
Deaths: 0 deaths
12 mg LY3502970
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
24 mg LY3502970
Serious events: 5 serious events
Other events: 32 other events
Deaths: 0 deaths
36 mg LY3502970 - 1
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
36 mg LY3502970 - 2
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
45 mg LY3502970 - 1
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
45 mg LY3502970 - 2
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
1.5 mg Dulaglutide
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=55 participants at risk
Participants received matching placebo.
|
3 mg LY3502970
n=51 participants at risk
Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally QD.
|
12 mg LY3502970
n=56 participants at risk
Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
|
24 mg LY3502970
n=47 participants at risk
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
|
36 mg LY3502970 - 1
n=27 participants at risk
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.
|
36 mg LY3502970 - 2
n=34 participants at risk
Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.
|
45 mg LY3502970 - 1
n=31 participants at risk
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.
|
45 mg LY3502970 - 2
n=32 participants at risk
Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.
|
1.5 mg Dulaglutide
n=50 participants at risk
Participants received 1.5 mg Dulaglutide administered SC QW.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure
|
1.8%
1/55 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Pylorospasm
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.8%
1/56 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
1.8%
1/55 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.8%
1/55 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.8%
1/55 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Ischaemic stroke
|
1.8%
1/55 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.7%
1/27 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Urethral haemorrhage
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
Other adverse events
| Measure |
Placebo
n=55 participants at risk
Participants received matching placebo.
|
3 mg LY3502970
n=51 participants at risk
Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally QD.
|
12 mg LY3502970
n=56 participants at risk
Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
|
24 mg LY3502970
n=47 participants at risk
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
|
36 mg LY3502970 - 1
n=27 participants at risk
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.
|
36 mg LY3502970 - 2
n=34 participants at risk
Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.
|
45 mg LY3502970 - 1
n=31 participants at risk
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.
|
45 mg LY3502970 - 2
n=32 participants at risk
Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.
|
1.5 mg Dulaglutide
n=50 participants at risk
Participants received 1.5 mg Dulaglutide administered SC QW.
|
|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Haemoglobin decreased
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.4%
2/27 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Lipase increased
|
3.6%
2/55 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.9%
2/51 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.9%
5/56 • Number of events 5 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.5%
4/47 • Number of events 4 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.7%
1/27 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
2/31 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Flatulence
|
1.8%
1/55 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.5%
4/47 • Number of events 5 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
3/27 • Number of events 5 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.8%
4/51 • Number of events 4 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.6%
2/56 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.4%
3/47 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
18.5%
5/27 • Number of events 11 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.8%
3/34 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
2/31 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
4/56 • Number of events 4 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.4%
3/47 • Number of events 4 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
5.5%
3/55 • Number of events 4 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
23.5%
12/51 • Number of events 15 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
37.5%
21/56 • Number of events 27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
34.0%
16/47 • Number of events 20 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
37.0%
10/27 • Number of events 20 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
26.5%
9/34 • Number of events 18 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
29.0%
9/31 • Number of events 15 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
25.0%
8/32 • Number of events 9 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
18.0%
9/50 • Number of events 13 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.4%
3/56 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.7%
1/27 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
2/47 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.9%
2/51 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.4%
3/56 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
2/47 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.4%
2/27 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
3/51 • Number of events 5 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.8%
1/56 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.4%
3/47 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.4%
2/27 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/55 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.7%
7/51 • Number of events 9 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
7/56 • Number of events 8 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.8%
6/47 • Number of events 7 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
22.2%
6/27 • Number of events 6 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
4/32 • Number of events 5 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
4/55 • Number of events 6 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
21.6%
11/51 • Number of events 18 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.1%
9/56 • Number of events 10 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
14.9%
7/47 • Number of events 11 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
25.9%
7/27 • Number of events 8 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
29.0%
9/31 • Number of events 10 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
28.1%
9/32 • Number of events 11 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.0%
6/50 • Number of events 7 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
2/55 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.8%
6/51 • Number of events 6 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
4/56 • Number of events 4 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.4%
3/47 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
3/27 • Number of events 5 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
2/31 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.4%
2/27 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/55 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
21.4%
12/56 • Number of events 16 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
27.7%
13/47 • Number of events 16 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
9/27 • Number of events 28 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
20.6%
7/34 • Number of events 9 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
35.5%
11/31 • Number of events 18 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
21.9%
7/32 • Number of events 10 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.0%
4/50 • Number of events 4 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Asthenia
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.4%
2/27 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Fatigue
|
3.6%
2/55 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.9%
5/56 • Number of events 5 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.7%
1/27 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
2/31 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/17 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
5.5%
3/55 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.9%
2/51 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.9%
5/56 • Number of events 5 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
2/47 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
2/50 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
4/55 • Number of events 5 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.9%
2/51 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.8%
1/56 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
2/47 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
2/50 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
2/50 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Weight decreased
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.6%
2/56 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
2/47 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
3/27 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.4%
3/56 • Number of events 4 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
2/47 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.4%
2/27 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
2/31 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.4%
3/32 • Number of events 4 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
2/50 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.1%
5/55 • Number of events 5 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.6%
2/56 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.7%
1/27 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 4 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
1/55 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.4%
3/47 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.8%
1/55 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.8%
1/56 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
1.8%
1/55 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.8%
4/51 • Number of events 4 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.8%
1/56 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
2/47 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.7%
7/51 • Number of events 9 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.6%
2/56 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
2/47 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
2/31 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
4/32 • Number of events 4 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
1.8%
1/55 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
1/47 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.00%
0/28 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/36 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/55 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.6%
2/56 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.4%
2/27 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
7.3%
4/55 • Number of events 4 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.8%
1/56 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.7%
1/27 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
2/50 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 28)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60