Trial Outcomes & Findings for A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids (NCT NCT05952856)

NCT ID: NCT05952856

Last Updated: 2026-08-06

Results Overview

Blood samples collected at baseline and Week 24 were used to assess mean percent change in LDL-C.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2912 participants

Primary outcome timeframe

Baseline and Week 24

Results posted on

2026-08-06

Participant Flow

Participants ≥18 years old with a prior major atherosclerotic cardiovascular disease (ASCVD) event and low-density lipoprotein cholesterol (LDL-C) ≥55 mg/dL (≥1.42 mmol/L) or, if they had no prior ASCVD event, were at intermediate-to-high risk for a first major ASCVD event with LDL-C ≥70 mg/dL (≥1.81 mmol/L) were eligible to be enrolled in this study.

A total of 2912 participants were originally enrolled in the study. 3 participants were simultaneously enrolled at more than one study site or in more than one enlicitide study. As pre-specified in the protocol for cases of simultaneous enrollment, these participants were excluded from all analyses, including disposition.

Participant milestones

Participant milestones
Measure	Enlicitide Decanoate Participants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.	Placebo Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Overall Study STARTED	1940	969
Overall Study Treated	1935	969
Overall Study COMPLETED	1831	918
Overall Study NOT COMPLETED	109	51

Reasons for withdrawal

Reasons for withdrawal
Measure	Enlicitide Decanoate Participants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.	Placebo Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Overall Study Legally accepted representative unavailable	0	1
Overall Study Death	15	8
Overall Study Lost to Follow-up	3	2
Overall Study Physician Decision	2	1
Overall Study Mistakenly Randomized Not Treated	2	0
Overall Study Withdrawal by Subject	85	35
Overall Study Enrolled in another non-enlicitide study	0	1
Overall Study Refused to continue in study	1	0
Overall Study Lost interest	1	0
Overall Study Participant moved	0	3

Baseline Characteristics

Participants with baseline data were analyzed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enlicitide Decanoate n=1940 Participants Participants received 20 mg of enlicitide decanoate orally QD for up to 52 weeks.	Placebo n=969 Participants Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.	Total n=2909 Participants Total of all reporting groups
Age, Continuous	62.8 Years STANDARD_DEVIATION 10.7 • n=1940 Participants	62.7 Years STANDARD_DEVIATION 10.7 • n=969 Participants	62.8 Years STANDARD_DEVIATION 10.7 • n=2909 Participants
Sex: Female, Male Female	775 Participants n=1940 Participants	367 Participants n=969 Participants	1142 Participants n=2909 Participants
Sex: Female, Male Male	1165 Participants n=1940 Participants	602 Participants n=969 Participants	1767 Participants n=2909 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	545 Participants n=1940 Participants	258 Participants n=969 Participants	803 Participants n=2909 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1385 Participants n=1940 Participants	706 Participants n=969 Participants	2091 Participants n=2909 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=1940 Participants	5 Participants n=969 Participants	15 Participants n=2909 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=1940 Participants	2 Participants n=969 Participants	6 Participants n=2909 Participants
Race (NIH/OMB) Asian	512 Participants n=1940 Participants	253 Participants n=969 Participants	765 Participants n=2909 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1940 Participants	0 Participants n=969 Participants	0 Participants n=2909 Participants
Race (NIH/OMB) Black or African American	173 Participants n=1940 Participants	79 Participants n=969 Participants	252 Participants n=2909 Participants
Race (NIH/OMB) White	1030 Participants n=1940 Participants	538 Participants n=969 Participants	1568 Participants n=2909 Participants
Race (NIH/OMB) More than one race	221 Participants n=1940 Participants	97 Participants n=969 Participants	318 Participants n=2909 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=1940 Participants	0 Participants n=969 Participants	0 Participants n=2909 Participants
Baseline Statin Dose Intensity No statin therapy	65 Participants n=1940 Participants	35 Participants n=969 Participants	100 Participants n=2909 Participants
Baseline Statin Dose Intensity Low intensity	24 Participants n=1940 Participants	11 Participants n=969 Participants	35 Participants n=2909 Participants
Baseline Statin Dose Intensity Moderate intensity	812 Participants n=1940 Participants	384 Participants n=969 Participants	1196 Participants n=2909 Participants
Baseline Statin Dose Intensity High intensity	1039 Participants n=1940 Participants	539 Participants n=969 Participants	1578 Participants n=2909 Participants
Baseline Low-density Lipoprotein Cholesterol (LDL-C)	95.0 mg/dL STANDARD_DEVIATION 38.8 • n=1935 Participants • Participants with baseline data were analyzed.	98.3 mg/dL STANDARD_DEVIATION 39.2 • n=969 Participants • Participants with baseline data were analyzed.	96.1 mg/dL STANDARD_DEVIATION 38.9 • n=2904 Participants • Participants with baseline data were analyzed.

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: All randomized participants who received at least 1 dose of study intervention and who had baseline data for LDL-C.

Blood samples collected at baseline and Week 24 were used to assess mean percent change in LDL-C.

Outcome measures

Outcome measures
Measure	Enlicitide Decanoate n=1935 Participants Participants received 20 mg of enlicitide decanoate orally QD for up to 52 weeks.	Placebo n=969 Participants Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24	-57.1 Percent change Interval -61.8 to -52.5	3.0 Percent change Interval 0.9 to 5.1

PRIMARY outcome

Timeframe: Up to 60 weeks

Population: All randomized participants who received at least 1 dose of study intervention.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Outcome measures

Outcome measures
Measure	Enlicitide Decanoate n=1935 Participants Participants received 20 mg of enlicitide decanoate orally QD for up to 52 weeks.	Placebo n=969 Participants Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Number of Participants With One or More Adverse Events (AEs)	1244 Participants	602 Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: All randomized participants who received at least 1 dose of study intervention.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Outcome measures

Outcome measures
Measure	Enlicitide Decanoate n=1935 Participants Participants received 20 mg of enlicitide decanoate orally QD for up to 52 weeks.	Placebo n=969 Participants Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Number of Participants Who Discontinued Study Drug Due to an AE	60 Participants	40 Participants

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: All randomized participants who received at least 1 dose of study intervention and who had baseline data for LDL-C.

Blood samples collected at baseline and Week 52 were used to assess mean percent change in LDL-C.

Outcome measures

Outcome measures
Measure	Enlicitide Decanoate n=1935 Participants Participants received 20 mg of enlicitide decanoate orally QD for up to 52 weeks.	Placebo n=969 Participants Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Mean Percent Change From Baseline in LDL-C at Week 52	-50.4 Percent change Interval -54.2 to -46.6	4.0 Percent change Interval 1.7 to 6.3

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: All randomized participants who received at least 1 dose of study intervention and who had baseline data for non-HDL-C.

Blood samples collected at baseline and Week 24 were used to assess mean percent change in non-HDL-C.

Outcome measures

Outcome measures
Measure	Enlicitide Decanoate n=1935 Participants Participants received 20 mg of enlicitide decanoate orally QD for up to 52 weeks.	Placebo n=969 Participants Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24	-53.7 Percent change Interval -55.0 to -52.5	2.6 Percent change Interval 0.8 to 4.5

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: All randomized participants who received at least 1 dose of study intervention and who had baseline data for ApoB.

Blood samples collected at baseline and Week 24 were used to assess mean percent change in ApoB.

Outcome measures

Outcome measures
Measure	Enlicitide Decanoate n=1932 Participants Participants received 20 mg of enlicitide decanoate orally QD for up to 52 weeks.	Placebo n=962 Participants Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24	-49.6 Percent change Interval -50.8 to -48.5	2.9 Percent change Interval 1.3 to 4.4

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: All randomized participants who received at least 1 dose of study intervention and who had baseline data for Lp(a).

Blood samples collected at baseline and Week 24 were used to assess percent change in Lp(a).

Outcome measures

Outcome measures
Measure	Enlicitide Decanoate n=1928 Participants Participants received 20 mg of enlicitide decanoate orally QD for up to 52 weeks.	Placebo n=960 Participants Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Percent Change From Baseline in Lipoprotein(a) (Lp(a)) at Week 24	29.0 Percent change Interval -96.1 to 476.0	0.0 Percent change Interval -76.6 to 430.3

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: All randomized participants who received at least 1 dose of study intervention and who had baseline data for LDL-C.

Blood samples collected at baseline and Week 24 were used to assess the percentage of participants who have LDL-C \<70 mg/dL and ≥50% reduction from baseline. Participants who did not have a Week 24 assessment are considered as not being at the LDL-C goal.

Outcome measures

Outcome measures
Measure	Enlicitide Decanoate n=1935 Participants Participants received 20 mg of enlicitide decanoate orally QD for up to 52 weeks.	Placebo n=969 Participants Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at Week 24	70.3 Percentage of participants	1.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: All randomized participants who received at least 1 dose of study intervention and who had baseline data for LDL-C.

Blood samples collected at baseline and Week 24 were used to assess the percentage of participants who have LDL-C \<55 mg/dL and ≥50% reduction from baseline. Participants who did not have a Week 24 assessment are considered as not being at the LDL-C goal.

Outcome measures

Outcome measures
Measure	Enlicitide Decanoate n=1935 Participants Participants received 20 mg of enlicitide decanoate orally QD for up to 52 weeks.	Placebo n=969 Participants Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Percentage of Participants With LDL-C <55 mg/dL and ≥50% Reduction From Baseline at Week 24	67.5 Percentage of participants	1.2 Percentage of participants

POST_HOC outcome

Timeframe: Baseline and Week 24

Population: All randomized participants who received at least 1 dose of study intervention and who had baseline data for LDL-C.

Blood samples collected at baseline and Week 24 were used to assess mean percent change in LDL-C. Data reanalysed according to revised data handling rules treating beta-quantification (BQ) values \</=0 as missing.

Outcome measures

Outcome measures
Measure	Enlicitide Decanoate n=1935 Participants Participants received 20 mg of enlicitide decanoate orally QD for up to 52 weeks.	Placebo n=969 Participants Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24 Reanalysis (Post-hoc )	-59.6 Percent change Interval -61.1 to -58.1	3.0 Percent change Interval 0.9 to 5.1

POST_HOC outcome

Timeframe: Baseline and Week 52

Population: All randomized participants who received at least 1 dose of study intervention and who had baseline data for LDL-C.

Blood samples collected at baseline and Week 52 were used to assess mean percent change in LDL-C. Data reanalysed according to revised data handling rules treating BQ values \</=0 as missing.

Outcome measures

Outcome measures
Measure	Enlicitide Decanoate n=1935 Participants Participants received 20 mg of enlicitide decanoate orally QD for up to 52 weeks.	Placebo n=969 Participants Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Mean Percent Change From Baseline in LDL-C at Week 52 Reanalysis (Post-hoc )	-52.7 Percent change Interval -54.4 to -50.9	4.0 Percent change Interval 1.7 to 6.3

Adverse Events

Enlicitide 20 mg

Serious events: 191 serious events

Other events: 0 other events

Deaths: 15 deaths

Placebo

Serious events: 116 serious events

Other events: 0 other events

Deaths: 8 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Enlicitide 20 mg n=1935 participants at risk Participants received 20 mg of enlicitide decanoate orally QD for up to 52 weeks.	Placebo n=969 participants at risk Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Cardiac disorders Angina unstable	0.47% 9/1935 • Number of events 10 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.62% 6/969 • Number of events 6 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Blood and lymphatic system disorders Anaemia	0.10% 2/1935 • Number of events 2 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.21% 2/969 • Number of events 2 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/1935 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.10% 1/969 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Acute coronary syndrome	0.10% 2/1935 • Number of events 2 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.21% 2/969 • Number of events 2 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Acute myocardial infarction	0.36% 7/1935 • Number of events 7 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.21% 2/969 • Number of events 2 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Angina pectoris	0.26% 5/1935 • Number of events 5 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.21% 2/969 • Number of events 2 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Aortic valve stenosis	0.00% 0/1935 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.10% 1/969 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Arteriosclerosis coronary artery	0.05% 1/1935 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.10% 1/969 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Atrial fibrillation	0.10% 2/1935 • Number of events 3 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.41% 4/969 • Number of events 4 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Atrial flutter	0.10% 2/1935 • Number of events 2 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.00% 0/969 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Atrial tachycardia	0.00% 0/1935 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.10% 1/969 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Atrioventricular block complete	0.00% 0/1935 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.10% 1/969 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Bradycardia	0.05% 1/1935 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.00% 0/969 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Cardiac arrest	0.10% 2/1935 • Number of events 2 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.10% 1/969 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Cardiac failure	0.26% 5/1935 • Number of events 6 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.31% 3/969 • Number of events 4 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Cardiac failure acute	0.10% 2/1935 • Number of events 2 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.10% 1/969 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Cardiac failure congestive	0.05% 1/1935 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.10% 1/969 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Cardiomyopathy	0.00% 0/1935 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.10% 1/969 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Coronary artery disease	0.16% 3/1935 • Number of events 3 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.21% 2/969 • Number of events 2 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Coronary artery occlusion	0.16% 3/1935 • Number of events 5 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.00% 0/969 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Coronary artery stenosis	0.10% 2/1935 • Number of events 2 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.00% 0/969 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Intracardiac mass	0.00% 0/1935 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.10% 1/969 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Ischaemic cardiomyopathy	0.05% 1/1935 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.00% 0/969 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Left ventricular failure	0.05% 1/1935 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.00% 0/969 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Myocardial infarction	0.10% 2/1935 • Number of events 2 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.21% 2/969 • Number of events 2 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Myocardial ischaemia	0.05% 1/1935 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.00% 0/969 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Pericarditis	0.00% 0/1935 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.10% 1/969 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Sinus arrest	0.05% 1/1935 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.00% 0/969 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Supraventricular extrasystoles	0.05% 1/1935 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.00% 0/969 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Systolic dysfunction	0.05% 1/1935 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.00% 0/969 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Tachycardia	0.00% 0/1935 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.10% 1/969 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Ventricular extrasystoles	0.05% 1/1935 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.00% 0/969 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Cardiac disorders Ventricular tachycardia	0.00% 0/1935 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.10% 1/969 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Ear and labyrinth disorders Sudden hearing loss	0.05% 1/1935 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.10% 1/969 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Ear and labyrinth disorders Vertigo	0.10% 2/1935 • Number of events 2 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.00% 0/969 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Ear and labyrinth disorders Vertigo positional	0.05% 1/1935 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.00% 0/969 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Endocrine disorders Goitre	0.05% 1/1935 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.00% 0/969 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Eye disorders Cataract	0.16% 3/1935 • Number of events 3 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.00% 0/969 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Eye disorders Retinal detachment	0.05% 1/1935 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.00% 0/969 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.
Eye disorders Uveitis	0.05% 1/1935 • Number of events 1 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.	0.00% 0/969 • All-cause mortality (ACM): From randomization Up to 60 weeks; Adverse Event (AE): From first treatment Up to 60 weeks. The ACM population consisted of randomized participants. The AE population consisted of treated participants.