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Trial Outcomes & Findings for A Study of LY3819469 in Participants With Elevated Lipoprotein(a) [Lp(a)] (NCT NCT05565742)

NCT ID: NCT05565742

Last Updated: 2025-05-28

Results Overview

LPa levels were assessed using Immuno turbidimetric method. Percent change is calculated as: Percent Change=\[(Lp(a) at Time Point-Lp(a) at Baseline)/Lp(a) at Baseline\]×100 Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with log(Lp(a)) - log(Baseline) = log(Baseline) + Treatment + Time + Treatment\*Time (Type III sum of squares) as post-baseline measures. Result presented is after back-transformation. Variance-Covariance structure = Unstructured. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

320 participants

Primary outcome timeframe

Baseline, Days 60 - 180

Results posted on

2025-05-28

Participant Flow

Participant milestones

Participant milestones
Measure
16 mg LY3819469
Participants received 16 milligrams (mg) of LY3819469 on day 1 and day 180, administered as a subcutaneous (SC) injection.
96 mg LY3819469
Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
400 mg LY3819469
Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
400 mg LY3819469 + Placebo
Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.
Placebo
Participants received placebo on day 1 and day 180, administered as a SC injection.
Overall Study
STARTED
36
74
69
72
69
Overall Study
Received at Least One Dose of Study Drug
36
74
69
72
69
Overall Study
Full Analysis Set (FAS)
36
74
69
72
69
Overall Study
Efficacy Analysis Set (EAS)
36
74
69
72
69
Overall Study
COMPLETED
35
74
67
70
66
Overall Study
NOT COMPLETED
1
0
2
2
3

Reasons for withdrawal

Reasons for withdrawal
Measure
16 mg LY3819469
Participants received 16 milligrams (mg) of LY3819469 on day 1 and day 180, administered as a subcutaneous (SC) injection.
96 mg LY3819469
Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
400 mg LY3819469
Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
400 mg LY3819469 + Placebo
Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.
Placebo
Participants received placebo on day 1 and day 180, administered as a SC injection.
Overall Study
Withdrawal by Subject
0
0
2
2
2
Overall Study
Death
1
0
0
0
0
Overall Study
Participant Travelled Abroad
0
0
0
0
1

Baseline Characteristics

A Study of LY3819469 in Participants With Elevated Lipoprotein(a) [Lp(a)]

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
16 mg LY3819469
n=36 Participants
Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
96 mg LY3819469
n=74 Participants
Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
400 mg LY3819469
n=69 Participants
Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
400 mg LY3819469 + Placebo
n=72 Participants
Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.
Placebo
n=69 Participants
Participants received placebo on day 1 and day 180, administered as a SC injection.
Total
n=320 Participants
Total of all reporting groups
Age, Continuous
62.6 years
STANDARD_DEVIATION 10.55 • n=5 Participants
63.8 years
STANDARD_DEVIATION 9.9 • n=7 Participants
61.4 years
STANDARD_DEVIATION 10.93 • n=5 Participants
62.2 years
STANDARD_DEVIATION 9.65 • n=4 Participants
63.5 years
STANDARD_DEVIATION 8.42 • n=21 Participants
62.7 years
STANDARD_DEVIATION 9.84 • n=8 Participants
Sex: Female, Male
Female
9 Participants
n=5 Participants
35 Participants
n=7 Participants
35 Participants
n=5 Participants
27 Participants
n=4 Participants
32 Participants
n=21 Participants
138 Participants
n=8 Participants
Sex: Female, Male
Male
27 Participants
n=5 Participants
39 Participants
n=7 Participants
34 Participants
n=5 Participants
45 Participants
n=4 Participants
37 Participants
n=21 Participants
182 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants
n=5 Participants
8 Participants
n=7 Participants
10 Participants
n=5 Participants
17 Participants
n=4 Participants
2 Participants
n=21 Participants
44 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
28 Participants
n=5 Participants
66 Participants
n=7 Participants
59 Participants
n=5 Participants
55 Participants
n=4 Participants
67 Participants
n=21 Participants
275 Participants
n=8 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
0 Participants
n=21 Participants
1 Participants
n=8 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
2 Participants
n=4 Participants
0 Participants
n=21 Participants
5 Participants
n=8 Participants
Race (NIH/OMB)
Asian
3 Participants
n=5 Participants
13 Participants
n=7 Participants
13 Participants
n=5 Participants
8 Participants
n=4 Participants
10 Participants
n=21 Participants
47 Participants
n=8 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
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
2 Participants
n=4 Participants
0 Participants
n=21 Participants
7 Participants
n=8 Participants
Race (NIH/OMB)
White
30 Participants
n=5 Participants
58 Participants
n=7 Participants
53 Participants
n=5 Participants
60 Participants
n=4 Participants
59 Participants
n=21 Participants
260 Participants
n=8 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 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
Region of Enrollment
Argentina
5 Participants
n=5 Participants
6 Participants
n=7 Participants
5 Participants
n=5 Participants
6 Participants
n=4 Participants
2 Participants
n=21 Participants
24 Participants
n=8 Participants
Region of Enrollment
Netherlands
2 Participants
n=5 Participants
11 Participants
n=7 Participants
9 Participants
n=5 Participants
7 Participants
n=4 Participants
7 Participants
n=21 Participants
36 Participants
n=8 Participants
Region of Enrollment
Romania
3 Participants
n=5 Participants
3 Participants
n=7 Participants
2 Participants
n=5 Participants
4 Participants
n=4 Participants
1 Participants
n=21 Participants
13 Participants
n=8 Participants
Region of Enrollment
United States
8 Participants
n=5 Participants
17 Participants
n=7 Participants
19 Participants
n=5 Participants
19 Participants
n=4 Participants
24 Participants
n=21 Participants
87 Participants
n=8 Participants
Region of Enrollment
China
0 Participants
n=5 Participants
3 Participants
n=7 Participants
1 Participants
n=5 Participants
3 Participants
n=4 Participants
3 Participants
n=21 Participants
10 Participants
n=8 Participants
Region of Enrollment
Japan
3 Participants
n=5 Participants
10 Participants
n=7 Participants
11 Participants
n=5 Participants
5 Participants
n=4 Participants
5 Participants
n=21 Participants
34 Participants
n=8 Participants
Region of Enrollment
Denmark
4 Participants
n=5 Participants
4 Participants
n=7 Participants
5 Participants
n=5 Participants
4 Participants
n=4 Participants
12 Participants
n=21 Participants
29 Participants
n=8 Participants
Region of Enrollment
Mexico
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
4 Participants
n=4 Participants
0 Participants
n=21 Participants
8 Participants
n=8 Participants
Region of Enrollment
Germany
5 Participants
n=5 Participants
12 Participants
n=7 Participants
8 Participants
n=5 Participants
6 Participants
n=4 Participants
10 Participants
n=21 Participants
41 Participants
n=8 Participants
Region of Enrollment
Spain
4 Participants
n=5 Participants
8 Participants
n=7 Participants
7 Participants
n=5 Participants
14 Participants
n=4 Participants
5 Participants
n=21 Participants
38 Participants
n=8 Participants
Lipoprotein(a) [Lp(a)] level
267.63 Nanomole/Liter (nmol/L)
STANDARD_DEVIATION 81.80 • n=5 Participants
278.86 Nanomole/Liter (nmol/L)
STANDARD_DEVIATION 79.53 • n=7 Participants
276.66 Nanomole/Liter (nmol/L)
STANDARD_DEVIATION 100.68 • n=5 Participants
279.98 Nanomole/Liter (nmol/L)
STANDARD_DEVIATION 93.50 • n=4 Participants
266.62 Nanomole/Liter (nmol/L)
STANDARD_DEVIATION 91.31 • n=21 Participants
274.74 Nanomole/Liter (nmol/L)
STANDARD_DEVIATION 89.98 • n=8 Participants

PRIMARY outcome

Timeframe: Baseline, Days 60 - 180

Population: Full Analysis Set. As specified in the Protocol and statistical analysis plan (SAP), for the primary analysis up to Day 180, the two LY3819469 treatment groups assigned to 400 mg (400 mg LY3819469, 400 mg LY3819469 + placebo) were pooled into one treatment group (400 mg LY3819469 pooled) because participants received the same study intervention in the first 180 days

LPa levels were assessed using Immuno turbidimetric method. Percent change is calculated as: Percent Change=\[(Lp(a) at Time Point-Lp(a) at Baseline)/Lp(a) at Baseline\]×100 Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with log(Lp(a)) - log(Baseline) = log(Baseline) + Treatment + Time + Treatment\*Time (Type III sum of squares) as post-baseline measures. Result presented is after back-transformation. Variance-Covariance structure = Unstructured. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable.

Outcome measures

Outcome measures
Measure
16 mg LY3819469
n=36 Participants
Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
96 mg LY3819469
n=74 Participants
Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
400 mg LY3819469 and 400 mg LY3819469 + Placebo (400 mg LY3819469 Pooled)
n=141 Participants
Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection. Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.
Placebo
n=69 Participants
Participants received placebo on day 1 and day 180, administered as a SC injection.
Placebo
Participants received placebo on day 1 and day 180, administered as a SC injection.
Percent Change From Baseline in Time Averaged Lipoprotein(a) [Lp(a)] Over Days 60-180
-39.0 percent change
Standard Error 7.37
-74.4 percent change
Standard Error 2.16
-93.7 percent change
Standard Error 0.38
3.1 percent change
Standard Error 8.99
—

SECONDARY outcome

Timeframe: Baseline, Days 240 - 360

Population: Efficacy Analysis Set.

LPa levels were assessed using Immuno turbidimetric method. LS mean was determined using MMRM model with log(Lp(a)) - log(Baseline) = log(Baseline) + Treatment + Time + Treatment\*Time (Type III sum of squares) as post-baseline measures.. Result presented is after back-transformation. Variance-Covariance structure = Unstructured. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable.

Outcome measures

Outcome measures
Measure
16 mg LY3819469
n=36 Participants
Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
96 mg LY3819469
n=74 Participants
Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
400 mg LY3819469 and 400 mg LY3819469 + Placebo (400 mg LY3819469 Pooled)
n=69 Participants
Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection. Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.
Placebo
n=72 Participants
Participants received placebo on day 1 and day 180, administered as a SC injection.
Placebo
n=69 Participants
Participants received placebo on day 1 and day 180, administered as a SC injection.
Percent Change From Baseline in Time Averaged Lp(a) Over Days 240-360
-38.7 percent change
Standard Error 7.66
-77.4 percent change
Standard Error 1.97
-95.0 percent change
Standard Error 0.45
-76.7 percent change
Standard Error 2.06
0.3 percent change
Standard Error 9.07

SECONDARY outcome

Timeframe: Days 60, 180

Population: Efficacy Analysis Set. Overall Number of Participants Analyzed = number of participants in each group. Number Analyzed = participants with available data at specified time points. As specified in the protocol and SAP, for the primary analysis up to Day 180, two LY3819469 treatment groups assigned to 400 mg (400 mg LY3819469,400 mg LY3819469 + placebo) were pooled into one treatment group (400 mg LY3819469 pooled) because participants are receiving same study intervention in the first 180 days.

Percentage of Participants Achieving Lp(a) \<125 and \<75 Nanomole/Liter (nmol/L) at Days 60, 180 is reported.

Outcome measures

Outcome measures
Measure
16 mg LY3819469
n=36 Participants
Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
96 mg LY3819469
n=74 Participants
Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
400 mg LY3819469 and 400 mg LY3819469 + Placebo (400 mg LY3819469 Pooled)
n=141 Participants
Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection. Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.
Placebo
n=69 Participants
Participants received placebo on day 1 and day 180, administered as a SC injection.
Placebo
Participants received placebo on day 1 and day 180, administered as a SC injection.
Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 60, 180
Lp(a) <125 nmol/L: Day 60
37.14 percentage of participants
86.30 percentage of participants
97.81 percentage of participants
0.00 percentage of participants
—
Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 60, 180
Lp(a) <125 nmol/L: Day 180
14.29 percentage of participants
58.33 percentage of participants
90.15 percentage of participants
0.00 percentage of participants
—
Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 60, 180
Lp(a) <75 nmol/L: Day 180
8.57 percentage of participants
33.33 percentage of participants
81.06 percentage of participants
0.00 percentage of participants
—
Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 60, 180
Lp(a) <75 nmol/L: Day 60
14.29 percentage of participants
64.38 percentage of participants
96.35 percentage of participants
0.00 percentage of participants
—

SECONDARY outcome

Timeframe: Days 240, 360, and 540

Population: Efficacy Analysis Set. Overall Number of Participants Analyzed = number of participants in each group. Number Analyzed = participants with available data at specified time points.

Percentage of Participants Achieving Lp(a) \<125 and \<75 Nanomole/Liter (Nmol/L) at Days 240, 360, and 540 is reported.

Outcome measures

Outcome measures
Measure
16 mg LY3819469
n=36 Participants
Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
96 mg LY3819469
n=74 Participants
Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
400 mg LY3819469 and 400 mg LY3819469 + Placebo (400 mg LY3819469 Pooled)
n=69 Participants
Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection. Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.
Placebo
n=72 Participants
Participants received placebo on day 1 and day 180, administered as a SC injection.
Placebo
n=69 Participants
Participants received placebo on day 1 and day 180, administered as a SC injection.
Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 240, 360, and 540
Lp(a) <75 nmol/L: Day 360
6.06 percentage of participants
41.18 percentage of participants
82.54 percentage of participants
42.19 percentage of participants
0.00 percentage of participants
Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 240, 360, and 540
Lp(a) <125 nmol/L: Day 240
36.36 percentage of participants
88.06 percentage of participants
98.41 percentage of participants
78.79 percentage of participants
1.56 percentage of participants
Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 240, 360, and 540
Lp(a) <125 nmol/L: Day 360
24.24 percentage of participants
58.82 percentage of participants
88.89 percentage of participants
59.38 percentage of participants
0.00 percentage of participants
Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 240, 360, and 540
Lp(a) <125 nmol/L: Day 540
9.38 percentage of participants
32.31 percentage of participants
75.41 percentage of participants
35.48 percentage of participants
0.00 percentage of participants
Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 240, 360, and 540
Lp(a) <75 nmol/L: Day 240
18.18 percentage of participants
76.12 percentage of participants
96.83 percentage of participants
65.15 percentage of participants
1.56 percentage of participants
Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 240, 360, and 540
Lp(a) <75 nmol/L: Day 540
0.00 percentage of participants
16.92 percentage of participants
45.90 percentage of participants
16.13 percentage of participants
0.00 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Days 60, 180, 240, 360, and 540

Population: Efficacy Analysis Set. Overall Number of Participants Analyzed = number of participants in each group. Number Analyzed = participants with available data at specified time points.

LS mean was determined using MMRM model with log(Actual Measurement/Baseline) = log (Baseline) + High Risk CV Stratum (yes/no) + Treatment + Time + Treatment\*Time (Type III sum of squares) as post-baseline measures. Variance-Covariance structure (Change from Baseline) = Unstructured. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable.

Outcome measures

Outcome measures
Measure
16 mg LY3819469
n=36 Participants
Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
96 mg LY3819469
n=74 Participants
Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
400 mg LY3819469 and 400 mg LY3819469 + Placebo (400 mg LY3819469 Pooled)
n=69 Participants
Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection. Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.
Placebo
n=72 Participants
Participants received placebo on day 1 and day 180, administered as a SC injection.
Placebo
n=69 Participants
Participants received placebo on day 1 and day 180, administered as a SC injection.
Percent Change From Baseline in Lp(a)
Baseline, Day 180
-30.5 percent change
Standard Error 9.17
-65.3 percent change
Standard Error 3.20
-90.5 percent change
Standard Error 0.64
-90.5 percent change
Standard Error 0.64
2.2 percent change
Standard Error 9.78
Percent Change From Baseline in Lp(a)
Baseline, Day 60
-46.2 percent change
Standard Error 6.04
-80.4 percent change
Standard Error 1.53
-95.4 percent change
Standard Error 0.26
-95.4 percent change
Standard Error 0.26
2.2 percent change
Standard Error 8.29
Percent Change From Baseline in Lp(a)
Baseline, Day 240
-47.7 percent change
Standard Error 6.63
-84.8 percent change
Standard Error 1.35
-96.8 percent change
Standard Error 0.23
-84.9 percent change
Standard Error 1.09
-0.8 percent change
Standard Error 9.10
Percent Change From Baseline in Lp(a)
Baseline, Day 360
-30.8 percent change
Standard Error 9.19
-67.7 percent change
Standard Error 2.99
-91.1 percent change
Standard Error 0.69
-68.1 percent change
Standard Error 2.46
-0.9 percent change
Standard Error 9.53
Percent Change From Baseline in Lp(a)
Baseline, Day 540
-18.7 percent change
Standard Error 8.56
-45.1 percent change
Standard Error 4.04
-73.8 percent change
Standard Error 1.69
-52.8 percent change
Standard Error 3.04
1.3 percent change
Standard Error 7.76

SECONDARY outcome

Timeframe: Baseline, Days 60, 180, 240, 360, and 540

Population: Efficacy Analysis Set. Overall Number of Participants Analyzed = number of participants in each group. Number Analyzed = participants with available data at specified time points.

LS mean was determined using MMRM model with log (Actual Measurement/Baseline) = log(Baseline) + Baseline Lp(a) stratum (\<275 nmol/L vs. \>=275 nmol/L) + High Risk CV Stratum (yes/no) + Treatment + Time + Treatment\*Time (Type III sum of squares as post-baseline measures. Variance-Covariance structure (Change from Baseline) = Unstructured. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable.

Outcome measures

Outcome measures
Measure
16 mg LY3819469
n=36 Participants
Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
96 mg LY3819469
n=74 Participants
Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
400 mg LY3819469 and 400 mg LY3819469 + Placebo (400 mg LY3819469 Pooled)
n=69 Participants
Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection. Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.
Placebo
n=72 Participants
Participants received placebo on day 1 and day 180, administered as a SC injection.
Placebo
n=69 Participants
Participants received placebo on day 1 and day 180, administered as a SC injection.
Percent Change From Baseline in Apolipoprotein B (ApoB)
Baseline, Day 180
-7.0 percent change
Standard Error 3.49
-9.6 percent change
Standard Error 2.37
-12.6 percent change
Standard Error 1.68
-12.6 percent change
Standard Error 1.68
1.3 percent change
Standard Error 2.78
Percent Change From Baseline in Apolipoprotein B (ApoB)
Baseline, Day 60
-10.2 percent change
Standard Error 3.07
-11.8 percent change
Standard Error 2.10
-13.9 percent change
Standard Error 1.49
-13.9 percent change
Standard Error 1.49
0.2 percent change
Standard Error 2.47
Percent Change From Baseline in Apolipoprotein B (ApoB)
Baseline, Day 240
-7.6 percent change
Standard Error 3.24
-13.8 percent change
Standard Error 2.11
-14.0 percent change
Standard Error 1.98
-9.0 percent change
Standard Error 2.05
1.8 percent change
Standard Error 2.58
Percent Change From Baseline in Apolipoprotein B (ApoB)
Baseline, Day 360
-2.9 percent change
Standard Error 3.56
-8.1 percent change
Standard Error 2.35
-10.4 percent change
Standard Error 2.20
-4.6 percent change
Standard Error 2.33
4.3 percent change
Standard Error 2.77
Percent Change From Baseline in Apolipoprotein B (ApoB)
Baseline, Day 540
1.4 percent change
Standard Error 3.55
-0.6 percent change
Standard Error 2.42
-9.1 percent change
Standard Error 2.13
-0.9 percent change
Standard Error 2.31
4.3 percent change
Standard Error 2.64

SECONDARY outcome

Timeframe: Baseline, Days 60, 180, 240, 360, and 540

Population: Efficacy Analysis Set. Overall Number of Participants Analyzed = number of participants in each group. Number Analyzed = participants with available data at specified time points.

hsCRP is a laboratory analyte that is an indicator of inflammation. Decreases in hsCRP represent reductions in inflammation. LS mean was determined using MMRM model with log (Actual Measurement/Baseline) = log(Baseline) + Baseline Lp(a) stratum (\<275 nmol/L vs. \>=275 nmol/L) + High Risk CV Stratum (yes/no) + Treatment + Time + Treatment\*Time (Type III sum of squares as post-baseline measures. Variance-Covariance structure (Change from Baseline) = Unstructured. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable.

Outcome measures

Outcome measures
Measure
16 mg LY3819469
n=36 Participants
Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
96 mg LY3819469
n=74 Participants
Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
400 mg LY3819469 and 400 mg LY3819469 + Placebo (400 mg LY3819469 Pooled)
n=69 Participants
Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection. Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.
Placebo
n=72 Participants
Participants received placebo on day 1 and day 180, administered as a SC injection.
Placebo
n=69 Participants
Participants received placebo on day 1 and day 180, administered as a SC injection.
Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)
Baseline, Day 180
10.6 percent change
Standard Error 18.22
-6.5 percent change
Standard Error 10.59
16.2 percent change
Standard Error 9.72
16.2 percent change
Standard Error 9.72
10.3 percent change
Standard Error 13.17
Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)
Baseline, Day 240
-3.4 percent change
Standard Error 13.02
-8.4 percent change
Standard Error 8.60
7.3 percent change
Standard Error 9.50
-1.2 percent change
Standard Error 8.67
9.1 percent change
Standard Error 10.52
Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)
Baseline, Day 360
43.6 percent change
Standard Error 25.21
13.5 percent change
Standard Error 13.89
10.4 percent change
Standard Error 12.90
32.3 percent change
Standard Error 15.36
10.8 percent change
Standard Error 14.04
Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)
Baseline, Day 540
-7.7 percent change
Standard Error 14.93
-1.2 percent change
Standard Error 11.19
0.9 percent change
Standard Error 11.12
14.1 percent change
Standard Error 12.65
0.1 percent change
Standard Error 11.89
Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)
Baseline, Day 60
-15.4 percent change
Standard Error 13.94
0.1 percent change
Standard Error 11.22
-1.9 percent change
Standard Error 8.00
-1.9 percent change
Standard Error 8.00
2.1 percent change
Standard Error 11.87

SECONDARY outcome

Timeframe: Day 1: 0.5 hours, 4-9 hours post-dose; Day 180: 24-36 hours post-dose

Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.

AUC was computed using the population PK model. Therefore, the concentrations are simulated from time 0 to infinity to estimate AUC for each participant. The timeframe reflects the PK timepoints that were collected to develop the population PK. Although this is a multiple dose study, the plasma PK is very short, so AUC0-180days is equivalent to AUC0-infinity.

Outcome measures

Outcome measures
Measure
16 mg LY3819469
n=35 Participants
Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
96 mg LY3819469
n=74 Participants
Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
400 mg LY3819469 and 400 mg LY3819469 + Placebo (400 mg LY3819469 Pooled)
n=69 Participants
Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection. Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.
Placebo
n=72 Participants
Participants received placebo on day 1 and day 180, administered as a SC injection.
Placebo
Participants received placebo on day 1 and day 180, administered as a SC injection.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3819469
1853 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 36
10110 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 26
55242 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 42
46633 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 13
—

Adverse Events

16 mg LY3819469

Serious events: 1 serious events
Other events: 14 other events
Deaths: 1 deaths

96 mg LY3819469

Serious events: 9 serious events
Other events: 25 other events
Deaths: 0 deaths

400 mg LY3819469

Serious events: 11 serious events
Other events: 34 other events
Deaths: 0 deaths

400 mg LY3819469 + Placebo

Serious events: 8 serious events
Other events: 35 other events
Deaths: 0 deaths

Placebo

Serious events: 6 serious events
Other events: 26 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
16 mg LY3819469
n=36 participants at risk
Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection
96 mg LY3819469
n=74 participants at risk
Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
400 mg LY3819469
n=69 participants at risk
Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
400 mg LY3819469 + Placebo
n=72 participants at risk
Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.
Placebo
n=69 participants at risk
Participants received placebo on day 1 and day 180, administered as a SC injection.
Cardiac disorders
Acute myocardial infarction
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/72 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders
Angina unstable
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/74 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/72 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders
Atrial fibrillation
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders
Cardiac failure
2.8%
1/36 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders
Coronary artery disease
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/72 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders
Myocardial infarction
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/72 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders
Glaucoma
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/74 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders
Oedematous pancreatitis
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/72 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders
Pancreatitis
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/72 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders
Cardiac death
2.8%
1/36 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders
Non-cardiac chest pain
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/74 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations
Cellulitis
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/74 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations
Complicated appendicitis
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations
Diverticulitis
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations
Pilonidal disease
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations
Sepsis
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations
Urinary tract infection
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/74 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations
Vestibular neuronitis
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations
Viral infection
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications
Post procedural haematoma
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications
Wound
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/72 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders
Hyponatraemia
2.8%
1/36 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/74 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders
Spinal ligament ossification
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders
Spinal stenosis
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders
Spondylolisthesis
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
0.00%
0/9 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
2.9%
1/35 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/35 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/27 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/32 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/74 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders
Intracranial aneurysm
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders
Myelopathy
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders
Syncope
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders
Transient ischaemic attack
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/74 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders
Confusional state
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/72 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders
Hydronephrosis
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders
Ureterolithiasis
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders
Pelvic floor dysfunction
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/72 • Number of events 3 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/74 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Surgical and medical procedures
Coronary angioplasty
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/72 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.

Other adverse events

Other adverse events
Measure
16 mg LY3819469
n=36 participants at risk
Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection
96 mg LY3819469
n=74 participants at risk
Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
400 mg LY3819469
n=69 participants at risk
Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
400 mg LY3819469 + Placebo
n=72 participants at risk
Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.
Placebo
n=69 participants at risk
Participants received placebo on day 1 and day 180, administered as a SC injection.
Gastrointestinal disorders
Diarrhoea
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
5.8%
4/69 • Number of events 5 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
2.8%
2/72 • Number of events 2 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
4.3%
3/69 • Number of events 3 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders
Large intestine polyp
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/74 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
5.6%
4/72 • Number of events 5 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders
Injection site reaction
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
8.1%
6/74 • Number of events 8 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
11.6%
8/69 • Number of events 9 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
8.3%
6/72 • Number of events 6 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations
Covid-19
5.6%
2/36 • Number of events 2 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/74 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
7.2%
5/69 • Number of events 5 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
5.6%
4/72 • Number of events 4 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
10.1%
7/69 • Number of events 7 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations
Gastroenteritis
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/74 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
5.6%
4/72 • Number of events 4 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations
Influenza
11.1%
4/36 • Number of events 4 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
9.5%
7/74 • Number of events 9 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
2.9%
2/69 • Number of events 3 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
5.6%
4/72 • Number of events 4 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
2.9%
2/69 • Number of events 2 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations
Nasopharyngitis
5.6%
2/36 • Number of events 3 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
8.1%
6/74 • Number of events 6 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
7.2%
5/69 • Number of events 5 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
13.9%
10/72 • Number of events 10 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
8.7%
6/69 • Number of events 8 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations
Upper respiratory tract infection
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
6.8%
5/74 • Number of events 8 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
4.3%
3/69 • Number of events 3 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
8.3%
6/72 • Number of events 9 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations
Urinary tract infection
2.8%
1/36 • Number of events 2 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
2.7%
2/74 • Number of events 2 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
5.8%
4/69 • Number of events 7 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
2.8%
2/72 • Number of events 2 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
4.3%
3/69 • Number of events 6 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations
Alanine aminotransferase increased
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
5.8%
4/69 • Number of events 4 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations
Aspartate aminotransferase increased
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
5.8%
4/69 • Number of events 4 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders
Vitamin d deficiency
5.6%
2/36 • Number of events 2 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
2.7%
2/74 • Number of events 2 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders
Arthralgia
2.8%
1/36 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
2.7%
2/74 • Number of events 2 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
4.3%
3/69 • Number of events 3 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
8.3%
6/72 • Number of events 6 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
2.9%
2/69 • Number of events 2 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/74 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
2.9%
2/69 • Number of events 2 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
4.2%
3/72 • Number of events 3 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
5.8%
4/69 • Number of events 4 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders
Headache
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
2.7%
2/74 • Number of events 3 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
4.3%
3/69 • Number of events 3 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
4.2%
3/72 • Number of events 3 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
5.8%
4/69 • Number of events 5 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders
Ovarian cyst
11.1%
1/9 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/35 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/35 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/27 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/32 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/36 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
5.4%
4/74 • Number of events 4 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
2.9%
2/69 • Number of events 2 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
2.8%
2/72 • Number of events 2 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
1.4%
1/69 • Number of events 1 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
5.6%
2/36 • Number of events 2 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/74 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/72 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
0.00%
0/69 • Baseline Up to Day 540
FAS: All randomized participants who received at least one dose of study drug and are not discontinued due to inadvertent enrollment. For safety analysis FAS was used based on actual treatment received. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 08005455979

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60