Trial Outcomes & Findings for A Study to Assess Cardiovascular Outcomes Following Treatment With Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (MK-3102-018) (NCT NCT01703208)

Last Updated: 2018-11-06

Results Overview

Participants with confirmed MACE-plus events (confirmed cardiovascular, CV-related death, nonfatal myocardial infarction \[MI\], nonfatal stroke, or hospitalization due to unstable angina). In the MK-3102-018 study, MACE plus events had a data cut-off date of April 15, 2015.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

4202 participants

Primary outcome timeframe

Up to 156 weeks

Results posted on

2018-11-06

Participant Flow

A total of 559 sites received IEC/IRB approval in 40 countries and 547 were shipped clinical supplies. Of the 559 sites, 525 screened at least 1 participant. An insulin sub-study of MK-3102-018 was performed and included the sub-population of participants receiving ≥20 units/day of background insulin with or without metformin.

On April 8, 2016, Merck \& Co. Inc. announced that it would not submit marketing applications for omarigliptin (MK-3102) in the US and Europe for business reasons only. Because of this decision, the MK-3102-018 study was terminated early on May 13, 2016. Due to delays in study close-out the Last-Participant-Last-Visit occurred on March 22, 2017.

Participant milestones

Participant milestones
Measure	Omarigliptin 25 mg Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Study STARTED	2100	2102
Overall Study Treated	2092	2100
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2100	2102

Reasons for withdrawal

Reasons for withdrawal
Measure	Omarigliptin 25 mg Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Study Death	61	48
Overall Study Lack of Efficacy	1	2
Overall Study Lost to Follow-up	68	62
Overall Study Non-Compliance with Study Drug	1	0
Overall Study Excluded Medication	1	2
Overall Study Site Discontinued Study Participation	23	27
Overall Study Physician Decision	11	13
Overall Study Progressive disease	2	2
Overall Study Protocol Violation	1	1
Overall Study Study Terminated by Sponsor	1710	1716
Overall Study Withdrawal by Subject	205	209
Overall Study Adverse Event	14	19
Overall Study Technical Problems	0	1
Overall Study Protocol Deviation	2	0

Baseline Characteristics

A Study to Assess Cardiovascular Outcomes Following Treatment With Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (MK-3102-018)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omarigliptin 25 mg n=2100 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=2102 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.	Total n=4202 Participants Total of all reporting groups
Age, Continuous	63.7 Years STANDARD_DEVIATION 8.5 • n=5 Participants	63.6 Years STANDARD_DEVIATION 8.5 • n=7 Participants	63.6 Years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	639 Participants n=5 Participants	615 Participants n=7 Participants	1254 Participants n=5 Participants
Sex: Female, Male Male	1461 Participants n=5 Participants	1487 Participants n=7 Participants	2948 Participants n=5 Participants
Hemoglobin A1C %	7.99 Percent STANDARD_DEVIATION 0.86 • n=5 Participants	8.03 Percent STANDARD_DEVIATION 0.89 • n=7 Participants	8.01 Percent STANDARD_DEVIATION 0.87 • n=5 Participants
Fasting Plasma Glucose (FPG)	184.1 mg/dL STANDARD_DEVIATION 52.2 • n=5 Participants	179.5 mg/dL STANDARD_DEVIATION 45.7 • n=7 Participants	180.4 mg/dL STANDARD_DEVIATION 47.8 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 156 weeks

Population: The analysis population included all randomized participants who took at least one dose of blinded study medication and were evaluated for MACE-plus events.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=2090 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=2100 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Number of Participants With MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina)	66 Participants Interval -1.14 to -0.9	70 Participants Interval -1.2 to -0.96

PRIMARY outcome

Timeframe: Up to 179 weeks

Population: The analysis population included all randomized participants who took at least one dose of blinded trial medication.

Participants with an Event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction \[MI\], and fatal and nonfatal stroke).

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=2092 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=2100 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)	114 Participants Interval -1.14 to -0.9	114 Participants Interval -1.2 to -0.96

PRIMARY outcome

Timeframe: Up to 179 weeks

Population: The analysis population included all randomized participants who took at least one dose of blinded trial medication.

Participants with an event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction \[MI\], and fatal and nonfatal stroke). Person-years were calculated as the sum of all participants' follow-up time to first event.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=2092 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=2100 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Number of Participants With an Event Per 100 Person-Years for First Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)	2.96 Participants/100 Person-years Interval -1.14 to -0.9	2.97 Participants/100 Person-years Interval -1.2 to -0.96

PRIMARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population consisted of all randomized participants who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=2092 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=2100 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Change From Baseline in Hemoglobin A1C (A1C) at Week 18	-0.58 Percent 95% Confidence Interval 0.82 • Interval -0.62 to -0.55	-0.16 Percent 95% Confidence Interval 0.88 • Interval -0.19 to -0.12

PRIMARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population consists of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=535 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=509 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Change From Baseline in A1C at Week 18 in a Sub-Study of Participants Taking Insulin (With or Without Metformin)	-0.50 Percentage Interval -0.57 to -0.42	-0.11 Percentage Interval -0.19 to -0.03

PRIMARY outcome

Timeframe: Up to Week 18

Population: The analysis population included all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=535 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=509 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Percentage of Participants Who Experienced at Least One Adverse Event in a Sub-study of Participants Taking Insulin Excluding Data After Background Antihyperglycemic Agent (AHA) Change	48.8 Percentage of participants	49.9 Percentage of participants

PRIMARY outcome

Timeframe: Up to Week 18

Population: The analysis population included all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=535 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=509 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event in a Sub-Study of Participants Taking Insulin Excluding Data After Background AHA Change	1.1 Percentage of participants Interval -3.13 to -2.25	0.8 Percentage of participants Interval -4.18 to -3.29

SECONDARY outcome

Timeframe: Up to 179 weeks

Population: The analysis population consisted of all randomized participants who received at least one dose of blinded study medication.

Participants with adjudicated and confirmed AEs of cardiovascular-related death.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=2092 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=2100 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Number of Participants With an Event of CV-Related Death	37 Participants Interval -40.04 to -31.42	35 Participants Interval -41.21 to -32.62

SECONDARY outcome

Timeframe: Up to 179 weeks

Population: The analysis population consisted of all participants who took at least one dose of blinded study medication.

Participants with adjudicated and confirmed AEs of cardiovascular-related death. Person-years were calculated as the sum of all participants' follow-up time to event.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=2092 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=2100 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Number of Participants With an Event Per 100 Person-Years of CV-Related Death	0.94 Participants/100 person-years Interval -40.04 to -31.42	0.89 Participants/100 person-years Interval -41.21 to -32.62

SECONDARY outcome

Timeframe: Up to 179 weeks

Population: The analysis population consisted of all participants who took at least one dose of blinded study medication.

Participants with adjudicated and confirmed AEs of fatal and non-fatal MI.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=2092 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=2100 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Number of Participants With an Event of First MI (Fatal and Non-fatal)	52 Participants Interval -40.04 to -31.42	60 Participants Interval -41.21 to -32.62

SECONDARY outcome

Timeframe: Up to 179 weeks

Population: The analysis population consisted of all participants who took at least one dose of blinded study medication.

Participants with adjudicated and confirmed AEs of fatal and non-fatal MI. Person-years were calculated as the sum of all participants' follow-up time to first event.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=2092 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=2100 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Number of Participants With an Event Per 100 Person-Years of First MI (Fatal and Non-fatal)	1.34 Participants/100 person-years Interval -40.04 to -31.42	1.55 Participants/100 person-years Interval -41.21 to -32.62

SECONDARY outcome

Timeframe: Up to 179 weeks

Population: The analysis population consisted of all participants who took at least one dose of blinded study medication.

Participants with adjudicated and confirmed AEs fatal and non-fatal stroke.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=2092 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=2100 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Number of Participants With an Event of Stroke (Fatal and Non-fatal)	32 Participants Interval -40.04 to -31.42	34 Participants Interval -41.21 to -32.62

SECONDARY outcome

Timeframe: Up to 179 weeks

Population: The analysis population consisted of all participants who took at least one dose of blinded study medication.

Participants with adjudicated and confirmed AEs fatal and non-fatal stroke. Person-years were calculated as the sum of all participants' follow-up time to event.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=2092 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=2100 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Number of Participants With an Event Per 100 Person-Years of First Stroke (Fatal and Non-fatal)	0.82 Participants/100 person-years Interval -40.04 to -31.42	0.88 Participants/100 person-years Interval -41.21 to -32.62

SECONDARY outcome

Timeframe: Up to 179 weeks

Population: The analysis population included all randomized participants who took at least one dose of blinded trial medication.

All-cause death was death from any cause.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=2092 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=2100 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Number of Participants With an Event of All-Cause Death	64 Participants	50 Participants

SECONDARY outcome

Timeframe: Up to 179 weeks

Population: The analysis population included all randomized participants who took at least one dose of blinded study medication.

All-cause death was death for any cause. Person-years were calculated as the sum of all participants' follow-up time to event.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=2092 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=2100 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Number of Participants With an Event Per 100 Person-Years of the Event of All-Cause Death	1.63 Participants/100 Person-years	1.28 Participants/100 Person-years

SECONDARY outcome

Timeframe: Baseline and Week 142

Population: The analysis population consisted of all randomized participants who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 142 A1C minus the Week 0 A1C.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=2092 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=2100 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Change From Baseline in A1C at Week 142	-0.36 Percent 95% Confidence Interval 0.06 • Interval -0.47 to -0.25	-0.06 Percent 95% Confidence Interval 1.12 • Interval -0.17 to 0.05

SECONDARY outcome

Timeframe: 4 months

Population: Data for this efficacy endpoint was not collected, analyzed or summarized.

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 4 months

Population: Data for this efficacy endpoint was not collected, analyzed or summarized.

This change from baseline reflects the Month 4 FPG minus the Week 0 FPG.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 179 weeks

Population: Data for this efficacy endpoint was not collected, analyzed or summarized.

Long-term insulin therapy was defined as a continuous period of insulin use of more than 3 months.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 234 weeks

Population: The analysis population included all randomized participants who took at least one dose of blinded study medication.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=2092 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=2100 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Percentage of Participants Who Experienced at Least One Adverse Event	78.3 Percentage of participants	76.8 Percentage of participants

SECONDARY outcome

Timeframe: Up to 212 weeks

Population: The analysis population included all randomized participants who took at least one dose of blinded study medication.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=2092 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=2100 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event	4.1 Percentage of participants	3.6 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population consisted of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.

This change from baseline reflects the Week 18 FPG minus the Week 0 FPG.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=535 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=509 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Change From Baseline in FPG at Week 18 in a Sub-Study of Participants Taking Insulin	-6.8 mg/dL Interval -12.1 to -1.5	-3.6 mg/dL Interval -9.1 to 1.8

SECONDARY outcome

Timeframe: 18 weeks

Population: The analysis population consisted of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Analysis was performed with multiple data imputation.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=535 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=509 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/Mol) at Week 18 in a Sub-Study of Participants Taking Insulin	22.0 Percentage of participants Interval 18.5 to 26.1	10.2 Percentage of participants Interval 7.5 to 13.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 179 weeks

Population: The analysis population consisted of all participants who took at least one dose of blinded study medication.

Participants with adjudicated and confirmed events of first hospitalization for heart failure.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=2092 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=2100 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Number of Participants With an Event of First Hospitalization for Heart Failure (Exploratory)	20 Participants	33 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 179 weeks

Population: The analysis population consisted of all participants who took at least one dose of blinded study medication.

Participants with adjudicated and confirmed events of first hospitalization for heart failure. Person-years were calculated as the sum of all participants' follow-up time to event.

Outcome measures

Outcome measures
Measure	Omarigliptin 25 mg n=2092 Participants Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=2100 Participants Matching placebo to omarigliptin capsule or tablet administered once weekly.
Number of Participants With an Event Per 100 Person-years of the Event of the First Hospitalization for Heart Failure (Exploratory)	0.51 Participants/100 Person-years	0.85 Participants/100 Person-years

Adverse Events

Omarigliptin 25 mg

Serious events: 512 serious events

Other events: 788 other events

Deaths: 0 deaths

Placebo

Serious events: 503 serious events

Other events: 794 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Omarigliptin 25 mg n=2092 participants at risk Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Placebo n=2100 participants at risk Matching placebo to omarigliptin capsule or tablet administered once weekly.
Infections and infestations Nasopharyngitis	5.9% 123/2092 • Number of events 167 • Up to 234 weeks Participants with serious adverse events with an incidence \> 0% and with \>5% non-serous adverse events in one or more treatment groups during the Treatment Period + Post-Treatment Follow-up including Post-21 days after last dose of blinded study treatment for randomized participants receiving one or more doses of study treatment.	6.9% 145/2100 • Number of events 195 • Up to 234 weeks Participants with serious adverse events with an incidence \> 0% and with \>5% non-serous adverse events in one or more treatment groups during the Treatment Period + Post-Treatment Follow-up including Post-21 days after last dose of blinded study treatment for randomized participants receiving one or more doses of study treatment.
Infections and infestations Upper respiratory tract infection	5.9% 123/2092 • Number of events 163 • Up to 234 weeks Participants with serious adverse events with an incidence \> 0% and with \>5% non-serous adverse events in one or more treatment groups during the Treatment Period + Post-Treatment Follow-up including Post-21 days after last dose of blinded study treatment for randomized participants receiving one or more doses of study treatment.	5.7% 120/2100 • Number of events 150 • Up to 234 weeks Participants with serious adverse events with an incidence \> 0% and with \>5% non-serous adverse events in one or more treatment groups during the Treatment Period + Post-Treatment Follow-up including Post-21 days after last dose of blinded study treatment for randomized participants receiving one or more doses of study treatment.
Investigations Blood glucose increased	4.6% 97/2092 • Number of events 139 • Up to 234 weeks Participants with serious adverse events with an incidence \> 0% and with \>5% non-serous adverse events in one or more treatment groups during the Treatment Period + Post-Treatment Follow-up including Post-21 days after last dose of blinded study treatment for randomized participants receiving one or more doses of study treatment.	6.6% 139/2100 • Number of events 199 • Up to 234 weeks Participants with serious adverse events with an incidence \> 0% and with \>5% non-serous adverse events in one or more treatment groups during the Treatment Period + Post-Treatment Follow-up including Post-21 days after last dose of blinded study treatment for randomized participants receiving one or more doses of study treatment.
Metabolism and nutrition disorders Hypoglycaemia	25.3% 530/2092 • Number of events 3990 • Up to 234 weeks Participants with serious adverse events with an incidence \> 0% and with \>5% non-serous adverse events in one or more treatment groups during the Treatment Period + Post-Treatment Follow-up including Post-21 days after last dose of blinded study treatment for randomized participants receiving one or more doses of study treatment.	22.5% 473/2100 • Number of events 3688 • Up to 234 weeks Participants with serious adverse events with an incidence \> 0% and with \>5% non-serous adverse events in one or more treatment groups during the Treatment Period + Post-Treatment Follow-up including Post-21 days after last dose of blinded study treatment for randomized participants receiving one or more doses of study treatment.
Infections and infestations Urinary tract infection	5.2% 108/2092 • Number of events 131 • Up to 234 weeks Participants with serious adverse events with an incidence \> 0% and with \>5% non-serous adverse events in one or more treatment groups during the Treatment Period + Post-Treatment Follow-up including Post-21 days after last dose of blinded study treatment for randomized participants receiving one or more doses of study treatment.	4.7% 98/2100 • Number of events 141 • Up to 234 weeks Participants with serious adverse events with an incidence \> 0% and with \>5% non-serous adverse events in one or more treatment groups during the Treatment Period + Post-Treatment Follow-up including Post-21 days after last dose of blinded study treatment for randomized participants receiving one or more doses of study treatment.

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.
Publication restrictions are in place

Restriction type: OTHER