Trial Outcomes & Findings for Study to Assess the Tolerability and Efficacy of Anacetrapib (MK-0859) Co-Administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020) (NCT NCT01524289)

Last Updated: 2019-10-14

Results Overview

LDL-C levels were measured at baseline and week 52 (or at discontinuation) using a beta quantification method. The Treatment Phase was the period from the date of the participant's first dose of study treatment (randomization visit, Visit 3) to the participant's last visit on treatment (discontinuation visit or Visit 8 \[Week 52\]).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

306 participants

Primary outcome timeframe

Baseline and Week 52

Results posted on

2019-10-14

Participant Flow

This study was conducted at 26 study centers. Participants were to complete a 2-week placebo run-in period, a 52-week randomized treatment phase and a 12-week reversal phase (safety follow-up).

The study enrolled participants who were 18 to 80 years old, had a genotype-confirmed or clinical diagnosis of heterozygous familial hypercholesterolemia (HeFH), and had been treated with an optimal dose of statin for at least 6 weeks.

Participant milestones

Participant milestones
Measure	Anacetrapib 100 mg Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Overall Study STARTED	204	102
Overall Study Treated	203	102
Overall Study COMPLETED	174	88
Overall Study NOT COMPLETED	30	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Anacetrapib 100 mg Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Overall Study Lost to Follow-up	0	1
Overall Study Physician Decision	1	0
Overall Study Protocol Violation	5	1
Overall Study Withdrawal by Subject	11	7
Overall Study Adverse Event	12	5
Overall Study Did not take study medication	1	0

Baseline Characteristics

Study to Assess the Tolerability and Efficacy of Anacetrapib (MK-0859) Co-Administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anacetrapib 100 mg n=204 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=102 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.	Total n=306 Participants Total of all reporting groups
Age, Continuous	55.0 Years STANDARD_DEVIATION 11.8 • n=93 Participants	55.7 Years STANDARD_DEVIATION 11.9 • n=4 Participants	55.3 Years STANDARD_DEVIATION 11.8 • n=27 Participants
Sex: Female, Male Female	84 Participants n=93 Participants	52 Participants n=4 Participants	136 Participants n=27 Participants
Sex: Female, Male Male	120 Participants n=93 Participants	50 Participants n=4 Participants	170 Participants n=27 Participants
Race/Ethnicity, Customized Asian	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Multi-racial	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Race/Ethnicity, Customized White	199 Participants n=93 Participants	100 Participants n=4 Participants	299 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and Week 52

Population: The full analysis set (FAS) population consisted of all randomized participants who received at least one dose of study treatment, had at least one post randomization observation for the analysis endpoint subsequent to at least one dose of study treatment and had baseline data for those analyses that require baseline data.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=165 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=85 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) - Treatment Phase	-36.0 Percent Change Interval -39.5 to -32.5	3.7 Percent Change Interval -1.2 to 8.6

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: The all participants as treated (APaT) population consisted of all randomized participants who received at least one dose of study treatment.

An adverse event (AE) or experience was any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a study treatment, whether or not considered related to the use of the study treatment. Any worsening of a preexisting condition which was temporally associated with the use of the study treatment is also an AE. The percentage of participants with any adverse event during the treatment phase is presented.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=203 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=102 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percentage of Participants With Any Adverse Event - Treatment Phase	76.4 Percentage of Participants	78.4 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: The APaT population consisted of all randomized participants who received at least one dose of study treatment.

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the treatment. Any worsening of a preexisting condition which was temporally associated with the use of the study treatment was also an AE. AEs reported by the investigator as definitely, probably or possibly related to study treatment were considered treatment-related. The percentage of participants with any treatment-related adverse event during the treatment phase is presented.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=203 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=102 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percentage of Participants With Any Treatment-Related Adverse Event - Treatment Phase	18.2 Percentage of Participants	13.7 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: The APaT population consisted of all randomized participants who received at least one dose of study treatment.

A serious adverse experience (SAE) was any adverse event that occurred at any dose that resulted in death or was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, or was a congenital anomaly/birth defect. The percentage of participants with any serious adverse event during the treatment phase is presented.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=203 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=102 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percentage of Participants With Any Serious Adverse Event - Treatment Phase	8.9 Percentage of Participants	9.8 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: The APaT population consists of all randomized participants who received at least one dose of study treatment.

An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which was temporally associated with the use of the study drug was also an AE. The percentage of participants who discontinued study treatment due to an AE during the treatment phase is presented.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=203 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=102 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event - Treatment Phase	5.9 Percentage of Participants	4.9 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one post-baseline test result that met pre-determined criteria.

Participants had SBP assessed at baseline and throughout the 52-week treatment period. Percentage of participants who had a SBP reading that was \>= 10 mm Hg higher than their baseline SBP for any assessment performed during the treatment phase is presented.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=202 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=101 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percentage of Participants With Changes in Systolic Blood Pressure (SBP) >= 10 mm Hg	45.0 Percentage of Participants	53.5 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Participants had SBP assessed at baseline and throughout the 52-week treatment period. The percentage of participants who had a SBP reading that was \>= 15 mm Hg higher than their baseline SBP for any assessment performed during the treatment phase is presented.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=202 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=101 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percentage of Participants With Changes in SBP >= 15 mm Hg	26.2 Percentage of Participants	33.7 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Participants had DBP assessed at baseline and throughout the 52-week treatment period. The percentage of participants who had a DBP reading that was \>= 10 mm Hg higher than their baseline DBP for any assessment performed during the treatment phase is presented.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=202 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=101 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percentage of Participants With Changes in Diastolic Blood Pressure (DBP) >= 10 mm Hg	22.8 Percentage of Participants	36.6 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Participants had sodium levels assessed throughout the 52-week treatment period. The percentage of participants who had any sodium level that was greater than the ULN of 145 mEq/L during the treatment phase is presented.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=202 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=101 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percentage of Participants With Sodium Levels > Upper Limit of Normal (ULN)	11.4 Percentage of Participants	9.9 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Participants had chloride levels assessed throughout the 52-week treatment period. The percentage of participants who had any chloride level that was \> the ULN of 110 mEq/L during the treatment phase is presented.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=202 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=101 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percentage of Participants With Chloride Levels > ULN	0.5 Percentage of Participants	0.0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Participants had potassium levels assessed throughout the 52-week treatment period. The percentage of participants who had any potassium level that was \< the LLN of 3.5 mEq/L during the treatment phase is presented.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=202 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=101 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percentage of Participants With Potassium Levels < Lower Limit of Normal (LLN)	1.5 Percentage of Participants	1.0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Participants had bicarbonate levels assessed throughout the 52-week treatment period. The percentage of participants who had any bicarbonate level that was \> the ULN of 33 mEq/L during the treatment phase is presented.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=202 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=101 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percentage of Participants With Bicarbonate Levels > ULN	0.0 Percentage of Participants	0.0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Participants had AST and ALT levels assessed throughout the 52-week treatment period. The percentage of participants who had 2 consecutive assessments of either AST or ALT that were 3 x ULN or greater during the treatment phase is presented.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=202 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=101 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percentage of Participants With Consecutive Changes in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x ULN	1.5 Percentage of Participants	1.0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Participants had CK levels assessed throughout the 52-week treatment period. The percentage of participants who had any CK level that was \>=10 x ULN during the treatment phase is presented.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=202 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=101 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percentage of Participants With Creatine Kinase (CK) Level >=10 x ULN	0.0 Percentage of Participants	1.0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Participants had CK levels assessed throughout the 52-week treatment period. The percentage of participants who had any CK level that was \>=10 x ULN and had associated muscle spasms during the treatment phase is presented.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=202 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=101 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percentage of Participants With CK Level >=10 x ULN With Muscle Spasms	0.0 Percentage of Participants	1.0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: The APaT population consisted of all randomized participants who received at least one dose of study treatment.

An AE or suspected adverse reaction was considered an SAE if it resulted in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. All events were adjudicated by an expert committee independent of the Sponsor. The percentage of participants that experienced adjudicated SAEs of CV death, non-fatal stroke, non-fatal myocardial infarction, or unstable angina during the treatment phase is presented.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=203 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=102 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percentage of Participants Adjudicated Cardiovascular (CV) SAE	1.5 Percentage of Participants	0.0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: The APaT population consisted of all randomized participants who received at least one dose of study treatment.

The percentage of participants who died from any cause during the treatment phase is presented. All deaths were adjudicated by an expert committee independent of the Sponsor.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=203 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=102 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percentage of Participants Who Died From Any Cause - Treatment Phase	0.0 Percentage of Participants	0.0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The FAS population consisted of all randomized participants who received at least one dose of study treatment and had at least one post randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that require baseline data.

The efficacy of adding anacetrapib 100 mg relative to placebo on plasma concentrations of high-density lipoprotein cholesterol (HDL-C) was evaluated at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=173 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=88 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percent Change From Baseline in High-Density Lipoprotein Cholesterol Levels	105.8 Percent Change Interval 101.1 to 110.6	3.7 Percent Change Interval -2.8 to 10.3

SECONDARY outcome

Timeframe: Baseline and Week 52

The efficacy of adding anacetrapib 100 mg was evaluated relative to placebo on plasma concentrations of non-high-density lipoprotein cholesterol (HDL-C) for the FAS population at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=173 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=88 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol Levels	-32.0 Percent Change Interval -35.1 to -28.9	4.4 Percent Change Interval 0.1 to 8.8

SECONDARY outcome

Timeframe: Baseline and Week 52

The efficacy of adding anacetrapib 100 mg was evaluated relative to placebo on plasma concentrations of apolipoprotein (Apo) B for the FAS population at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=173 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=88 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percent Change From Baseline in Apolipoprotein (Apo) B Levels	-19.6 Percent Change Interval -22.5 to -16.8	5.2 Percent Change Interval 1.3 to 9.1

SECONDARY outcome

Timeframe: Baseline and Week 52

The efficacy of adding anacetrapib 100 mg was evaluated relative to placebo on plasma concentrations of Apo A-1 for the FAS population at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=173 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=88 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percent Change From Baseline in Apolipoprotein (Apo) A-1 Levels	35.8 Percent Change Interval 33.0 to 38.6	2.9 Percent Change Interval -1.0 to 6.8

SECONDARY outcome

Timeframe: Baseline and Week 52

The efficacy of adding anacetrapib 100 mg was evaluated relative to placebo on plasma concentrations of lipoprotein(a) (Lp\[a\]) for the FAS population at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.

Outcome measures

Outcome measures
Measure	Anacetrapib 100 mg n=174 Participants Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.	Placebo n=88 Participants Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
Percent Change From Baseline in Lipoprotein(a) (Lp[a]) Levels	-31.8 Percent Change Interval -37.4 to -26.3	0.0 Percent Change Interval -5.1 to 5.1

Adverse Events

Anacetrapib 100 mg - Treatment Phase

Serious events: 18 serious events

Other events: 87 other events

Deaths: 0 deaths

Placebo - Treatment Phase

Serious events: 10 serious events

Other events: 41 other events

Deaths: 0 deaths

Anacetrapib 100 mg - Reversal Phase

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo - Reversal Phase

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Anacetrapib 100 mg - Treatment Phase n=203 participants at risk Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks.	Placebo - Treatment Phase n=102 participants at risk Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks.	Anacetrapib 100 mg - Reversal Phase n=196 participants at risk Safety data that was reported during the 12-week period from the day after the treatment phase to the participant's last visit (discontinuation visit or week 64).	Placebo - Reversal Phase n=95 participants at risk Safety data that was reported during the 12-week period from the day after the treatment phase to the participant's last visit (discontinuation visit or week 64).
Gastrointestinal disorders Diarrhoea	7.9% 16/203 • Number of events 19 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	8.8% 9/102 • Number of events 10 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	0.00% 0/196 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	0.00% 0/95 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).
Infections and infestations Gastroenteritis	0.99% 2/203 • Number of events 2 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	5.9% 6/102 • Number of events 7 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	0.00% 0/196 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	0.00% 0/95 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).
Infections and infestations Influenza	9.9% 20/203 • Number of events 22 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	10.8% 11/102 • Number of events 11 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	0.00% 0/196 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	0.00% 0/95 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).
Infections and infestations Nasopharyngitis	19.7% 40/203 • Number of events 50 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	18.6% 19/102 • Number of events 21 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	0.00% 0/196 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	0.00% 0/95 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 12/203 • Number of events 15 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	2.0% 2/102 • Number of events 2 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	0.00% 0/196 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	0.00% 0/95 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).
Musculoskeletal and connective tissue disorders Myalgia	8.9% 18/203 • Number of events 26 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	3.9% 4/102 • Number of events 5 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	0.00% 0/196 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	0.00% 0/95 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).
Nervous system disorders Headache	7.9% 16/203 • Number of events 19 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	5.9% 6/102 • Number of events 7 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	0.00% 0/196 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).	0.00% 0/95 • Up to 64 weeks Safety population: All participants who received at least 1 dose of study treatment. The treatment phase included AEs reported during the 52-week period from the date of the first dose of study treatment to the last visit on treatment (discontinuation visit or Week 52). The reversal phase included AEs reported during the 12-week period from the day after the treatment phase to the last visit (discontinuation or Week 64).

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication timelines.
Publication restrictions are in place

Restriction type: OTHER