Trial Outcomes & Findings for A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease (NCT NCT04992065)

NCT ID: NCT04992065

Last Updated: 2025-06-08

Results Overview

Percentage change in LDL-cholesterol (LDL-C) (measured in milligrams per deciliter \[mg/dL\]) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. The in-trial period is defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 267 participants
• Primary outcome timeframe: Baseline (week 0), week 12
• Results posted on: 2025-06-08

Participant Flow

The trial was conducted in 7 countries as follows (number of sites that screened participants/ number of sites that randomized participants): Belgium (5/5), Germany (4/4), Greece (6/6), Japan (4/4), Netherlands (6/6), Poland (5/5)and United States (12/12).

Participant milestones

Measure	NNC0385-0434 15 mg Participants received 15 milligrams (mg) NNC0385-0434 (co-formulated with 500 mg salcaprozate sodium \[SNAC\]) tablet orally once daily for 12 weeks.	NNC0385-0434 40 mg Participants received 40 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	NNC0385-0434 100 mg Participants received 100 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	Placebo Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks.	Evolocumab 140 mg Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks.
Overall Study STARTED	53	53	53	54	54
Overall Study Treated	53	53	53	54	54
Overall Study Full Analysis Set	53	53	53	54	54
Overall Study Safety Analysis Set	53	53	53	54	54
Overall Study COMPLETED	53	53	53	54	54
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease

Baseline characteristics by cohort

Measure	NNC0385-0434 15 mg n=53 Participants Participants received 15 milligrams (mg) NNC0385-0434 (co-formulated with 500 mg salcaprozate sodium \[SNAC\]) tablet orally once daily for 12 weeks.	NNC0385-0434 40 mg n=53 Participants Participants received 40 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	NNC0385-0434 100 mg n=53 Participants Participants received 100 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	Placebo n=54 Participants Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks.	Evolocumab 140 mg n=54 Participants Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks.	Total n=267 Participants Total of all reporting groups
Age, Continuous	64.1 Years STANDARD_DEVIATION 9.3 • n=5 Participants	64.6 Years STANDARD_DEVIATION 8.6 • n=7 Participants	65.2 Years STANDARD_DEVIATION 9.2 • n=5 Participants	63.1 Years STANDARD_DEVIATION 8.6 • n=4 Participants	64.5 Years STANDARD_DEVIATION 9.6 • n=21 Participants	64.3 Years STANDARD_DEVIATION 9.0 • n=10 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	17 Participants n=7 Participants	14 Participants n=5 Participants	17 Participants n=4 Participants	17 Participants n=21 Participants	82 Participants n=10 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	36 Participants n=7 Participants	39 Participants n=5 Participants	37 Participants n=4 Participants	37 Participants n=21 Participants	185 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants	53 Participants n=7 Participants	53 Participants n=5 Participants	52 Participants n=4 Participants	53 Participants n=21 Participants	264 Participants n=10 Participants
Ethnicity (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=10 Participants
Race/Ethnicity, Customized Race · Asian	7 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	6 Participants n=21 Participants	30 Participants n=10 Participants
Race/Ethnicity, Customized Race · Black or African American	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	11 Participants n=10 Participants
Race/Ethnicity, Customized Race · White	46 Participants n=5 Participants	44 Participants n=7 Participants	44 Participants n=5 Participants	46 Participants n=4 Participants	46 Participants n=21 Participants	226 Participants n=10 Participants
Race/Ethnicity, Customized Race · Other	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=10 Participants

PRIMARY outcome

Timeframe: Baseline (week 0), week 12

Population: FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Percentage change in LDL-cholesterol (LDL-C) (measured in milligrams per deciliter [mg/dL]) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. The in-trial period is defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.

Outcome measures

Measure	NNC0385-0434 15 mg n=51 Participants Participants received 15 milligrams (mg) NNC0385-0434 (co-formulated with 500 mg salcaprozate sodium \[SNAC\]) tablet orally once daily for 12 weeks.	NNC0385-0434 40 mg n=52 Participants Participants received 40 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	NNC0385-0434 100 mg n=49 Participants Participants received 100 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	Placebo n=52 Participants Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks.	Evolocumab 140 mg n=49 Participants Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks.
Percentage Change in Low-density Lipoprotein (LDL)-Cholesterol	-27 Percentage change of LDL cholesterol Standard Deviation 19	-41 Percentage change of LDL cholesterol Standard Deviation 37	-55 Percentage change of LDL cholesterol Standard Deviation 20	6 Percentage change of LDL cholesterol Standard Deviation 41	-59 Percentage change of LDL cholesterol Standard Deviation 22

SECONDARY outcome

Timeframe: Baseline (week 0), week 12

Population: FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Percentage change in total cholesterol (measured in millimoles per iliter [mmol/L]) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period.

Outcome measures

Measure	NNC0385-0434 15 mg n=52 Participants Participants received 15 milligrams (mg) NNC0385-0434 (co-formulated with 500 mg salcaprozate sodium \[SNAC\]) tablet orally once daily for 12 weeks.	NNC0385-0434 40 mg n=52 Participants Participants received 40 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	NNC0385-0434 100 mg n=50 Participants Participants received 100 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	Placebo n=53 Participants Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks.	Evolocumab 140 mg n=52 Participants Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks.
Percentage Change in Total Cholesterol	-14 Percentage change of total cholesterol Standard Deviation 13	-25 Percentage change of total cholesterol Standard Deviation 27	-33 Percentage change of total cholesterol Standard Deviation 11	4 Percentage change of total cholesterol Standard Deviation 23	-38 Percentage change of total cholesterol Standard Deviation 14

SECONDARY outcome

Timeframe: Baseline (week 0), week 12

Population: FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Percentage change in HDL-cholesterol (measured in mg/dL) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period.

Outcome measures

Measure	NNC0385-0434 15 mg n=52 Participants Participants received 15 milligrams (mg) NNC0385-0434 (co-formulated with 500 mg salcaprozate sodium \[SNAC\]) tablet orally once daily for 12 weeks.	NNC0385-0434 40 mg n=52 Participants Participants received 40 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	NNC0385-0434 100 mg n=47 Participants Participants received 100 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	Placebo n=53 Participants Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks.	Evolocumab 140 mg n=51 Participants Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks.
Percentage Change in High Density Lipoprotein (HDL)-Cholesterol	4 Percentage change of HDL cholesterol Standard Deviation 13	5 Percentage change of HDL cholesterol Standard Deviation 16	7 Percentage change of HDL cholesterol Standard Deviation 16	1 Percentage change of HDL cholesterol Standard Deviation 14	5 Percentage change of HDL cholesterol Standard Deviation 14

SECONDARY outcome

Timeframe: Baseline (week 0), week 12

Population: FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Percentage change in VLDL-cholesterol (measured in mmol/L) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period.

Outcome measures

Measure	NNC0385-0434 15 mg n=52 Participants Participants received 15 milligrams (mg) NNC0385-0434 (co-formulated with 500 mg salcaprozate sodium \[SNAC\]) tablet orally once daily for 12 weeks.	NNC0385-0434 40 mg n=52 Participants Participants received 40 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	NNC0385-0434 100 mg n=50 Participants Participants received 100 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	Placebo n=53 Participants Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks.	Evolocumab 140 mg n=52 Participants Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks.
Percentage Change in Very Low Density Lipoprotein (VLDL)-Cholesterol	5 Percentage change of VLDL cholesterol Standard Deviation 27	-7 Percentage change of VLDL cholesterol Standard Deviation 33	-15 Percentage change of VLDL cholesterol Standard Deviation 26	3 Percentage change of VLDL cholesterol Standard Deviation 41	-16 Percentage change of VLDL cholesterol Standard Deviation 24

SECONDARY outcome

Timeframe: Baseline (week 0), week 12

Population: FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Percentage change in triglycerides (measured in mg/dL) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period.

Outcome measures

Measure	NNC0385-0434 15 mg n=52 Participants Participants received 15 milligrams (mg) NNC0385-0434 (co-formulated with 500 mg salcaprozate sodium \[SNAC\]) tablet orally once daily for 12 weeks.	NNC0385-0434 40 mg n=52 Participants Participants received 40 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	NNC0385-0434 100 mg n=50 Participants Participants received 100 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	Placebo n=53 Participants Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks.	Evolocumab 140 mg n=52 Participants Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks.
Percentage Change in Triglycerides	5 Percentage change of triglycerides Standard Deviation 27	-7 Percentage change of triglycerides Standard Deviation 31	-16 Percentage change of triglycerides Standard Deviation 27	2 Percentage change of triglycerides Standard Deviation 41	-16 Percentage change of triglycerides Standard Deviation 23

SECONDARY outcome

Timeframe: Baseline (week 0), week 12

Population: FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Percentage change in Apo B (measured in mg/dL) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period.

Outcome measures

Measure	NNC0385-0434 15 mg n=51 Participants Participants received 15 milligrams (mg) NNC0385-0434 (co-formulated with 500 mg salcaprozate sodium \[SNAC\]) tablet orally once daily for 12 weeks.	NNC0385-0434 40 mg n=52 Participants Participants received 40 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	NNC0385-0434 100 mg n=49 Participants Participants received 100 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	Placebo n=53 Participants Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks.	Evolocumab 140 mg n=53 Participants Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks.
Percentage Change in Total Apolipoprotein B (Apo B)	-20 Percentage change of Apo B Standard Deviation 15	-34 Percentage change of Apo B Standard Deviation 28	-48 Percentage change of Apo B Standard Deviation 12	6 Percentage change of Apo B Standard Deviation 31	-52 Percentage change of Apo B Standard Deviation 17

SECONDARY outcome

Timeframe: Baseline (week 0), week 12

Population: FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Percentage change in Apo CIII (measured in mg/dL) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period.

Outcome measures

Measure	NNC0385-0434 15 mg n=50 Participants Participants received 15 milligrams (mg) NNC0385-0434 (co-formulated with 500 mg salcaprozate sodium \[SNAC\]) tablet orally once daily for 12 weeks.	NNC0385-0434 40 mg n=52 Participants Participants received 40 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	NNC0385-0434 100 mg n=48 Participants Participants received 100 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	Placebo n=51 Participants Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks.	Evolocumab 140 mg n=52 Participants Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks.
Percentage Change in Total Apolipoprotein CIII (Apo CIII)	-0 Percentage change of Apo CIII Standard Deviation 20	-7 Percentage change of Apo CIII Standard Deviation 24	-16 Percentage change of Apo CIII Standard Deviation 15	2 Percentage change of Apo CIII Standard Deviation 23	-15 Percentage change of Apo CIII Standard Deviation 21

SECONDARY outcome

Timeframe: Baseline (week 0), week 12

Population: FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change in total Lp(a) (measured in mg/dL) at week 12 is presented as ratio to baseline. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period.

Outcome measures

Measure	NNC0385-0434 15 mg n=52 Participants Participants received 15 milligrams (mg) NNC0385-0434 (co-formulated with 500 mg salcaprozate sodium \[SNAC\]) tablet orally once daily for 12 weeks.	NNC0385-0434 40 mg n=52 Participants Participants received 40 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	NNC0385-0434 100 mg n=50 Participants Participants received 100 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	Placebo n=53 Participants Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks.	Evolocumab 140 mg n=53 Participants Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks.
Change in Total Lipoprotein(a) (Lp[a]): Ratio to Baseline	0.79 Ratio of Lipoprotein (a) Geometric Coefficient of Variation 34.2	0.70 Ratio of Lipoprotein (a) Geometric Coefficient of Variation 37.6	0.66 Ratio of Lipoprotein (a) Geometric Coefficient of Variation 40.0	0.99 Ratio of Lipoprotein (a) Geometric Coefficient of Variation 31.5	0.59 Ratio of Lipoprotein (a) Geometric Coefficient of Variation 43.4

SECONDARY outcome

Timeframe: From baseline (week 0) to 138 days

Population: Safety analysis set (SAS) included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.

An adverse events (AE) is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP. All presented AEs are TEAEs. TEAEs was the number of AEs recorded during the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period.

Outcome measures

Measure	NNC0385-0434 15 mg n=53 Participants Participants received 15 milligrams (mg) NNC0385-0434 (co-formulated with 500 mg salcaprozate sodium \[SNAC\]) tablet orally once daily for 12 weeks.	NNC0385-0434 40 mg n=53 Participants Participants received 40 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	NNC0385-0434 100 mg n=53 Participants Participants received 100 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	Placebo n=54 Participants Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks.	Evolocumab 140 mg n=54 Participants Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks.
Number of Treatment-emergent Adverse Events (TEAEs)	82 Events	60 Events	65 Events	56 Events	81 Events

Adverse Events

NNC0385-0434 15 mg

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

NNC0385-0434 40 mg

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

NNC0385-0434 100 mg

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 14 other events

Deaths: 0 deaths

Evolocumab 140 mg

Serious events: 3 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	NNC0385-0434 15 mg n=53 participants at risk Participants received 15 milligrams (mg) NNC0385-0434 (co-formulated with 500 mg salcaprozate sodium \[SNAC\]) tablet orally once daily for 12 weeks.	NNC0385-0434 40 mg n=53 participants at risk Participants received 40 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	NNC0385-0434 100 mg n=53 participants at risk Participants received 100 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	Placebo n=54 participants at risk Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks.	Evolocumab 140 mg n=54 participants at risk Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks.
Hepatobiliary disorders Biliary colic	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	1.9% 1/54 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
General disorders Chest discomfort	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	1.9% 1/53 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Cardiac disorders Coronary artery stenosis	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	1.9% 1/54 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Cardiac disorders Diastolic dysfunction	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	1.9% 1/54 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Gastrointestinal disorders Dysphagia	1.9% 1/53 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Infections and infestations Herpes zoster	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	1.9% 1/54 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Nervous system disorders Loss of consciousness	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	1.9% 1/54 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	1.9% 1/54 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Nervous system disorders Myelopathy	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	1.9% 1/53 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
General disorders Non-cardiac chest pain	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	1.9% 1/53 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	1.9% 1/53 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	1.9% 1/54 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Vascular disorders Peripheral artery aneurysm	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	1.9% 1/53 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	1.9% 1/54 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Cardiac disorders Ventricular tachycardia	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	1.9% 1/54 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.

Other adverse events

Measure	NNC0385-0434 15 mg n=53 participants at risk Participants received 15 milligrams (mg) NNC0385-0434 (co-formulated with 500 mg salcaprozate sodium \[SNAC\]) tablet orally once daily for 12 weeks.	NNC0385-0434 40 mg n=53 participants at risk Participants received 40 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	NNC0385-0434 100 mg n=53 participants at risk Participants received 100 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.	Placebo n=54 participants at risk Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks.	Evolocumab 140 mg n=54 participants at risk Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks.
Investigations Blood creatine phosphokinase increased	1.9% 1/53 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	5.7% 3/53 • Number of events 3 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	7.4% 4/54 • Number of events 4 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	1.9% 1/54 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Infections and infestations COVID-19	5.7% 3/53 • Number of events 3 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	15.1% 8/53 • Number of events 8 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	15.1% 8/53 • Number of events 8 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	11.1% 6/54 • Number of events 6 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	11.1% 6/54 • Number of events 6 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Gastrointestinal disorders Constipation	5.7% 3/53 • Number of events 3 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	1.9% 1/54 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Gastrointestinal disorders Diarrhoea	7.5% 4/53 • Number of events 4 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	7.5% 4/53 • Number of events 4 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	3.8% 2/53 • Number of events 5 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	1.9% 1/54 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Gastrointestinal disorders Dyspepsia	1.9% 1/53 • Number of events 2 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	5.7% 3/53 • Number of events 4 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	1.9% 1/54 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Nervous system disorders Headache	7.5% 4/53 • Number of events 4 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	3.7% 2/54 • Number of events 2 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	5.6% 3/54 • Number of events 3 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Vascular disorders Hypertension	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	1.9% 1/53 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	1.9% 1/53 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	9.3% 5/54 • Number of events 5 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Musculoskeletal and connective tissue disorders Myalgia	5.7% 3/53 • Number of events 4 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	3.7% 2/54 • Number of events 2 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	3.7% 2/54 • Number of events 2 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Infections and infestations Nasopharyngitis	1.9% 1/53 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	5.7% 3/53 • Number of events 4 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	3.8% 2/53 • Number of events 2 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	5.6% 3/54 • Number of events 3 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Gastrointestinal disorders Nausea	1.9% 1/53 • Number of events 1 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	5.7% 3/53 • Number of events 4 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	5.7% 3/53 • Number of events 3 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/53 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	0.00% 0/54 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.	5.6% 3/54 • Number of events 3 • Up to 138 Days All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.

Additional Information

Clinical Reporting Office (2834)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: clinicaltrials@novonordisk.com

Results disclosure agreements

• Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
• Publication restrictions are in place

Restriction type: OTHER