Trial Outcomes & Findings for A Study of LY3437943 in Participants With Type 2 Diabetes (NCT NCT04867785)
NCT ID: NCT04867785
Last Updated: 2023-07-03
Results Overview
Change in HbA1c (%) from baseline in LY3437943 relative to placebo. HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Treatment\*Time + Strata\*Time + Baseline\*Time.
COMPLETED
PHASE2
281 participants
Baseline, 24 Weeks
2023-07-03
Participant Flow
Four maintenance doses of LY3437943 were evaluated: 0.5 mg, 4 mg, 8 mg, and 12 mg. Dose escalation occurred in certain cohorts up to Week 12 during the 36-week treatment period. For maintenance doses equal to or greater than 4 mg, the initial dose will be 2 mg or 4 mg followed by additional escalation steps as appropriate.
Participant milestones
| Measure |
Placebo
Participants received placebo administered as subcutaneous (SC) injection once weekly (QW).
|
1.5 Milligrams (mg) Dulaglutide
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
|
0.5 mg LY3437943
Participants received 0.5 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW.
|
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
45
|
46
|
47
|
23
|
24
|
26
|
24
|
46
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
45
|
46
|
47
|
23
|
24
|
26
|
24
|
46
|
|
Overall Study
COMPLETED
|
34
|
40
|
41
|
19
|
21
|
25
|
22
|
35
|
|
Overall Study
NOT COMPLETED
|
11
|
6
|
6
|
4
|
3
|
1
|
2
|
11
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo administered as subcutaneous (SC) injection once weekly (QW).
|
1.5 Milligrams (mg) Dulaglutide
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
|
0.5 mg LY3437943
Participants received 0.5 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW.
|
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
3
|
2
|
0
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
2
|
1
|
2
|
0
|
2
|
5
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Inadvertent Enrollment
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
|
Overall Study
Eligibility Criteria Not Met
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of LY3437943 in Participants With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo
n=45 Participants
Participants received placebo administered as SC injection QW.
|
1.5 mg Dulaglutide
n=46 Participants
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
|
0.5 mg LY3437943
n=47 Participants
Participants received 0.5 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=23 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=26 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=46 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW.
|
Total
n=281 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.56 years
STANDARD_DEVIATION 10.83 • n=5 Participants
|
54.94 years
STANDARD_DEVIATION 10.45 • n=7 Participants
|
57.21 years
STANDARD_DEVIATION 9.69 • n=5 Participants
|
57.70 years
STANDARD_DEVIATION 8.14 • n=4 Participants
|
57.58 years
STANDARD_DEVIATION 10.00 • n=21 Participants
|
57.00 years
STANDARD_DEVIATION 7.37 • n=8 Participants
|
53.83 years
STANDARD_DEVIATION 9.03 • n=8 Participants
|
54.37 years
STANDARD_DEVIATION 9.72 • n=24 Participants
|
56.19 years
STANDARD_DEVIATION 9.68 • n=42 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
26 Participants
n=24 Participants
|
156 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
20 Participants
n=24 Participants
|
125 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
20 Participants
n=24 Participants
|
131 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
26 Participants
n=24 Participants
|
148 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
33 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
38 Participants
n=24 Participants
|
235 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
46 participants
n=7 Participants
|
47 participants
n=5 Participants
|
23 participants
n=4 Participants
|
24 participants
n=21 Participants
|
26 participants
n=8 Participants
|
24 participants
n=8 Participants
|
46 participants
n=24 Participants
|
281 participants
n=42 Participants
|
|
Percentage of Hemoglobin A1c (HbA1c) at Baseline
|
8.39 Percentage of HbA1c
STANDARD_DEVIATION 1.139 • n=5 Participants
|
8.22 Percentage of HbA1c
STANDARD_DEVIATION 0.919 • n=7 Participants
|
8.35 Percentage of HbA1c
STANDARD_DEVIATION 1.172 • n=5 Participants
|
8.07 Percentage of HbA1c
STANDARD_DEVIATION 0.870 • n=4 Participants
|
8.20 Percentage of HbA1c
STANDARD_DEVIATION 1.207 • n=21 Participants
|
8.34 Percentage of HbA1c
STANDARD_DEVIATION 1.120 • n=8 Participants
|
8.20 Percentage of HbA1c
STANDARD_DEVIATION 1.261 • n=8 Participants
|
8.28 Percentage of HbA1c
STANDARD_DEVIATION 1.066 • n=24 Participants
|
8.27 Percentage of HbA1c
STANDARD_DEVIATION 1.086 • n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 WeeksPopulation: All randomized participants with baseline and post-baseline value at the specified time point excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
Change in HbA1c (%) from baseline in LY3437943 relative to placebo. HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Treatment\*Time + Strata\*Time + Baseline\*Time.
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received placebo administered as SC injection QW.
|
1.5 mg Dulaglutide
n=46 Participants
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
|
0.5 mg LY3437943
n=46 Participants
Participants received 0.5 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=22 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=25 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=43 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c)
|
-0.05 percentage of HbA1c
Standard Error 0.21
|
-1.41 percentage of HbA1c
Standard Error 0.12
|
-0.43 percentage of HbA1c
Standard Error 0.20
|
-1.39 percentage of HbA1c
Standard Error 0.14
|
-1.30 percentage of HbA1c
Standard Error 0.22
|
-1.99 percentage of HbA1c
Standard Error 0.15
|
-1.88 percentage of HbA1c
Standard Error 0.21
|
-2.01 percentage of HbA1c
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline, 24 WeeksPopulation: All randomized participants with baseline and post-baseline value at the specified time point excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
Change in HbA1c (%) from baseline in LY3437943 relative to dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Strata\*Time + Baseline\*Time.
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received placebo administered as SC injection QW.
|
1.5 mg Dulaglutide
n=46 Participants
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
|
0.5 mg LY3437943
n=46 Participants
Participants received 0.5 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=22 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=25 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=43 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in HbA1c
|
-0.05 percentage of HbA1c
Standard Error 0.21
|
-1.41 percentage of HbA1c
Standard Error 0.12
|
-0.43 percentage of HbA1c
Standard Error 0.20
|
-1.39 percentage of HbA1c
Standard Error 0.14
|
-1.30 percentage of HbA1c
Standard Error 0.22
|
-1.99 percentage of HbA1c
Standard Error 0.15
|
-1.88 percentage of HbA1c
Standard Error 0.21
|
-2.01 percentage of HbA1c
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline, 36 WeeksPopulation: All randomized participants with baseline and post-baseline value at the specified time point excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
Change in HbA1c (%) from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Baseline HbA1c Group (\<=8.5%, \>8.5%)\*Time + Baseline Body Mass Index (BMI) Group (\<30 kilograms/square meter (kg/m2), \>=30 kg/m2)\*Time + Baseline\*Time.
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received placebo administered as SC injection QW.
|
1.5 mg Dulaglutide
n=46 Participants
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
|
0.5 mg LY3437943
n=46 Participants
Participants received 0.5 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=22 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=25 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=43 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in HbA1c
|
-0.30 percentage of HbA1c
Standard Error 0.24
|
-1.36 percentage of HbA1c
Standard Error 0.13
|
-0.54 percentage of HbA1c
Standard Error 0.20
|
-1.30 percentage of HbA1c
Standard Error 0.20
|
-1.50 percentage of HbA1c
Standard Error 0.19
|
-2.13 percentage of HbA1c
Standard Error 0.17
|
-1.93 percentage of HbA1c
Standard Error 0.22
|
-2.16 percentage of HbA1c
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Week 24Population: All randomized participants with baseline and post-baseline value at the specified time point excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
Percentage of participants reaching HbA1c \<7.0% in LY3437943 relative to placebo and dulaglutide. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<30 kg/m2, ≥30 kg/m2\] as fixed effects, and baseline HbA1c value as a covariate.
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received placebo administered as SC injection QW.
|
1.5 mg Dulaglutide
n=46 Participants
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
|
0.5 mg LY3437943
n=46 Participants
Participants received 0.5 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=22 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=25 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=43 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reaching HbA1c <7.0%
|
18 percentage of participants
|
52 percentage of participants
|
32 percentage of participants
|
53 percentage of participants
|
66 percentage of participants
|
88 percentage of participants
|
78 percentage of participants
|
86 percentage of participants
|
SECONDARY outcome
Timeframe: Week 36Population: All randomized participants with baseline and post-baseline value at the specified time point excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
Percentage of participants reaching HbA1c \<7.0% in LY3437943 relative to placebo and dulaglutide. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<30 kg/m2, ≥30 kg/m2\] as fixed effects, and baseline HbA1c value as a covariate.
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received placebo administered as SC injection QW.
|
1.5 mg Dulaglutide
n=46 Participants
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
|
0.5 mg LY3437943
n=46 Participants
Participants received 0.5 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=22 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=25 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=43 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participant Reaching HbA1c <7.0%
|
22 percentage of participants
|
60 percentage of participants
|
37 percentage of participants
|
61 percentage of participants
|
59 percentage of participants
|
82 percentage of participants
|
78 percentage of participants
|
80 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 24 WeeksPopulation: All randomized participants with baseline and post-baseline value at the specified time point excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
Change in FBG from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Strata\*Time + Baseline\*Time.
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received placebo administered as SC injection QW.
|
1.5 mg Dulaglutide
n=46 Participants
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
|
0.5 mg LY3437943
n=46 Participants
Participants received 0.5 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=22 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=25 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=43 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (FBG)
|
-10.59 milligrams/deciliter (mg/dL)
Standard Error 5.98
|
-46.26 milligrams/deciliter (mg/dL)
Standard Error 4.35
|
-12.71 milligrams/deciliter (mg/dL)
Standard Error 6.95
|
-30.19 milligrams/deciliter (mg/dL)
Standard Error 12.65
|
-43.89 milligrams/deciliter (mg/dL)
Standard Error 8.42
|
-66.09 milligrams/deciliter (mg/dL)
Standard Error 3.70
|
-39.80 milligrams/deciliter (mg/dL)
Standard Error 10.79
|
-65.20 milligrams/deciliter (mg/dL)
Standard Error 4.38
|
SECONDARY outcome
Timeframe: Baseline, 36 WeeksPopulation: All randomized participants with baseline and post-baseline value at the specified time point excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
Change in FBG from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Baseline HbA1c Group (\<=8.5%, \>8.5%)\*Time + Baseline BMI Group (\<30kg/m2, \>=30kg/m2)\*Time + Baseline\*Time.
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received placebo administered as SC injection QW.
|
1.5 mg Dulaglutide
n=46 Participants
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
|
0.5 mg LY3437943
n=46 Participants
Participants received 0.5 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=22 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=25 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=43 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (FBG)
|
-17.26 mg/dL
Standard Error 10.87
|
-27.53 mg/dL
Standard Error 9.07
|
-17.51 mg/dL
Standard Error 5.59
|
-21.46 mg/dL
Standard Error 12.54
|
-38.72 mg/dL
Standard Error 10.81
|
-69.10 mg/dL
Standard Error 4.68
|
-41.20 mg/dL
Standard Error 14.43
|
-67.84 mg/dL
Standard Error 4.79
|
SECONDARY outcome
Timeframe: Baseline, 24 WeeksPopulation: All randomized participants with baseline and post-baseline value at the specified time point excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
Change in body weight from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Strata\*Time + Baseline\*Time.
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received placebo administered as SC injection QW.
|
1.5 mg Dulaglutide
n=46 Participants
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
|
0.5 mg LY3437943
n=46 Participants
Participants received 0.5 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=22 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=25 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=43 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight
|
-1.86 kilograms (kg)
Standard Error 0.66
|
-1.16 kilograms (kg)
Standard Error 0.63
|
-2.35 kilograms (kg)
Standard Error 0.48
|
-6.27 kilograms (kg)
Standard Error 0.94
|
-8.64 kilograms (kg)
Standard Error 1.23
|
-11.99 kilograms (kg)
Standard Error 0.84
|
-13.91 kilograms (kg)
Standard Error 1.38
|
-12.84 kilograms (kg)
Standard Error 0.93
|
SECONDARY outcome
Timeframe: Baseline, 36 WeeksPopulation: All randomized participants with baseline and post-baseline value at the specified time point excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
Change in body weight from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Baseline HbA1c Group (\<=8.5%, \>8.5%)\*Time + Baseline BMI Group (\<30kg/m2, \>=30kg/m2)\*Time + Baseline\*Time.
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received placebo administered as SC injection QW.
|
1.5 mg Dulaglutide
n=46 Participants
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
|
0.5 mg LY3437943
n=46 Participants
Participants received 0.5 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=22 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=25 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=43 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight
|
-3.28 kilograms (kg)
Standard Error 0.92
|
-1.97 kilograms (kg)
Standard Error 0.87
|
-3.31 kilograms (kg)
Standard Error 0.62
|
-7.28 kilograms (kg)
Standard Error 1.39
|
-10.37 kilograms (kg)
Standard Error 1.49
|
-16.48 kilograms (kg)
Standard Error 1.55
|
-16.12 kilograms (kg)
Standard Error 1.63
|
-17.18 kilograms (kg)
Standard Error 1.32
|
SECONDARY outcome
Timeframe: Predose: Week 0, 1, 4, 12, 24, 30; Postdose: Week 2, 8, 16, 20, 36Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
The average steady-state plasma concentration of LY3437943 was evaluated using sparse sampling methodology/Population PK (PopPK) modeling.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received placebo administered as SC injection QW.
|
1.5 mg Dulaglutide
n=21 Participants
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
|
0.5 mg LY3437943
n=24 Participants
Participants received 0.5 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=26 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (4 mg)
n=24 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=46 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|---|
|
Population PK: Average Steady-State Plasma Concentration (Cav,ss) of LY3437943
|
62.8 nanograms/milliliter (ng/mL)
|
466 nanograms/milliliter (ng/mL)
|
551 nanograms/milliliter (ng/mL)
|
1100 nanograms/milliliter (ng/mL)
|
1140 nanograms/milliliter (ng/mL)
|
1620 nanograms/milliliter (ng/mL)
|
—
|
—
|
Adverse Events
Placebo
1.5 Milligram (mg) Dulaglutide
0.5 mg LY3437943
4 mg LY3437943 (2 mg)
4 mg LY3437943 (4 mg)
8 mg LY3437943 (2 mg)
8 mg LY3437943 (4 mg)
12 mg LY3437943 (2 mg)
Serious adverse events
| Measure |
Placebo
n=45 participants at risk
Participants received placebo administered as SC injection QW.
|
1.5 Milligram (mg) Dulaglutide
n=46 participants at risk
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
|
0.5 mg LY3437943
n=47 participants at risk
Participants received 0.5 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=23 participants at risk
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (4 mg)
n=24 participants at risk
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=26 participants at risk
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=24 participants at risk
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=46 participants at risk
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/45 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/45 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring 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 Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
1/23 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal hernia
|
2.2%
1/45 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/45 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring 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 Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/45 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
2.2%
1/45 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/45 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/45 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring 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 Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/45 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
2.2%
1/45 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
2.2%
1/45 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/45 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/45 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
1/45 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/45 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring 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 Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.00%
0/45 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
4.5%
1/22 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Placebo
n=45 participants at risk
Participants received placebo administered as SC injection QW.
|
1.5 Milligram (mg) Dulaglutide
n=46 participants at risk
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
|
0.5 mg LY3437943
n=47 participants at risk
Participants received 0.5 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=23 participants at risk
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (4 mg)
n=24 participants at risk
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=26 participants at risk
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=24 participants at risk
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=46 participants at risk
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/45 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
2/24 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
2/46 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/45 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
1/23 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
2/24 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
2.2%
1/45 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.5%
3/46 • Number of events 4 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring 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 Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.7%
2/23 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
4/24 • Number of events 5 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.5%
3/26 • Number of events 3 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
2/24 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.9%
5/46 • Number of events 6 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
2/45 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.7%
4/46 • Number of events 5 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring 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 Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.7%
2/23 • Number of events 5 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
6/24 • Number of events 7 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
19.2%
5/26 • Number of events 10 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
29.2%
7/24 • Number of events 9 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.2%
7/46 • Number of events 8 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/45 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
2/46 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring 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 Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
2/26 • Number of events 4 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.5%
3/46 • Number of events 3 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/45 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
2/46 • Number of events 3 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring 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 Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
2/24 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/45 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.5%
3/24 • Number of events 3 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
4.4%
2/45 • Number of events 4 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
17.4%
8/46 • Number of events 13 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring 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 Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.7%
2/23 • Number of events 3 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
6/24 • Number of events 9 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
26.9%
7/26 • Number of events 9 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
41.7%
10/24 • Number of events 15 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
19.6%
9/46 • Number of events 13 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/45 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.7%
4/46 • Number of events 5 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring 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 Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
1/23 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
2/26 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
4/24 • Number of events 5 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.9%
5/46 • Number of events 11 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
0.00%
0/45 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring 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 Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
1/23 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
2/24 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.5%
3/24 • Number of events 4 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.5%
3/46 • Number of events 3 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
6.7%
3/45 • Number of events 3 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.7%
4/46 • Number of events 4 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.6%
5/47 • Number of events 5 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
13.0%
3/23 • Number of events 3 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
2/46 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
1/45 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.5%
3/46 • Number of events 3 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
4.4%
2/45 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
2/26 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.4%
2/45 • Number of events 3 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
2/24 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.9%
5/46 • Number of events 5 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
4.4%
2/45 • Number of events 3 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.5%
3/24 • Number of events 3 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.9%
5/46 • Number of events 6 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/33 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/16 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Lipase increased
|
4.4%
2/45 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring 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 Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
1/23 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
2/24 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.5%
3/26 • Number of events 3 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
2/46 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Weight decreased
|
0.00%
0/45 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
1/23 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
2/26 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
2/46 • Number of events 3 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/45 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
13.0%
6/46 • Number of events 6 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring 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 Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
1/23 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.8%
5/24 • Number of events 5 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
19.2%
5/26 • Number of events 5 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
4/24 • Number of events 4 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
19.6%
9/46 • Number of events 9 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
2.2%
1/45 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.7%
2/23 • Number of events 4 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
2/24 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.5%
3/24 • Number of events 4 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
2/46 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
4.4%
2/45 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.5%
3/46 • Number of events 3 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring 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 Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
1/23 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.5%
3/26 • Number of events 4 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Penile swelling
|
0.00%
0/22 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/33 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.2%
1/16 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/45 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring 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 Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.7%
2/23 • Number of events 2 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/26 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Baseline Through Study Completion (Up to 280 Days)
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring 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