Trial Outcomes & Findings for A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008) (NCT NCT05261126)

Last Updated: 2024-12-09

Results Overview

Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in LDL-C. Based on a constrained longitudinal analysis (cLDA) model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in LDL-C at week 8 was reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

381 participants

Primary outcome timeframe

Baseline and up to Week 8

Results posted on

2024-12-09

Participant Flow

Of 668 participants screened for inclusion, 381 were randomized 1:1:1:1:1 to receive MK-0616 6 mg, 12 mg, 18 mg, 30 mg, or placebo. Of the 381 randomized participants, one participant did not receive at least one dose of study intervention.

Participant milestones

Participant milestones
Measure	MK-0616 6 mg Participants received 6 mg of MK-0616 orally once daily (QD) for 8 weeks	MK-0616 12 mg Participants received 12 mg of MK-0616 orally QD for 8 weeks	MK-0616 18 mg Participants received 18 mg of MK-0616 orally QD for 8 weeks	MK-0616 30 mg Participants received 30 mg of MK-0616 orally QD for 8 weeks	Placebo Participants received MK-0616-matching placebo orally QD for 8 weeks
Overall Study STARTED	77	76	76	76	76
Overall Study Treated	77	76	76	76	75
Overall Study COMPLETED	75	76	74	74	74
Overall Study NOT COMPLETED	2	0	2	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	MK-0616 6 mg Participants received 6 mg of MK-0616 orally once daily (QD) for 8 weeks	MK-0616 18 mg Participants received 18 mg of MK-0616 orally QD for 8 weeks	MK-0616 30 mg Participants received 30 mg of MK-0616 orally QD for 8 weeks	Placebo Participants received MK-0616-matching placebo orally QD for 8 weeks
Overall Study Death	0	1	0	0
Overall Study Lost to Follow-up	0	0	0	1
Overall Study Physician Decision	1	0	0	0
Overall Study Screen Failure	0	0	0	1
Overall Study Withdrawal by Subject	1	1	1	0
Overall Study Not Recorded	0	0	1	0

Baseline Characteristics

A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-0616 6 mg n=77 Participants Participants received 6 mg of MK-0616 orally QD for 8 weeks	MK-0616 12 mg n=76 Participants Participants received 12 mg of MK-0616 orally QD for 8 weeks	MK-0616 18 mg n=76 Participants Participants received 18 mg of MK-0616 orally QD for 8 weeks	MK-0616 30 mg n=76 Participants Participants received 30 mg of MK-0616 orally QD for 8 weeks	Placebo n=76 Participants Participants received MK-0616-matching placebo orally QD for 8 weeks	Total n=381 Participants Total of all reporting groups
Age, Continuous	61.7 Years STANDARD_DEVIATION 10.3 • n=5 Participants	62.0 Years STANDARD_DEVIATION 9.4 • n=7 Participants	62.0 Years STANDARD_DEVIATION 9.2 • n=5 Participants	60.9 Years STANDARD_DEVIATION 10.2 • n=4 Participants	60.6 Years STANDARD_DEVIATION 9.3 • n=21 Participants	61.5 Years STANDARD_DEVIATION 9.7 • n=10 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	35 Participants n=7 Participants	39 Participants n=5 Participants	38 Participants n=4 Participants	38 Participants n=21 Participants	188 Participants n=10 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	41 Participants n=7 Participants	37 Participants n=5 Participants	38 Participants n=4 Participants	38 Participants n=21 Participants	193 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=5 Participants	29 Participants n=7 Participants	31 Participants n=5 Participants	31 Participants n=4 Participants	37 Participants n=21 Participants	154 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=5 Participants	46 Participants n=7 Participants	45 Participants n=5 Participants	45 Participants n=4 Participants	38 Participants n=21 Participants	225 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants	21 Participants n=10 Participants
Race (NIH/OMB) Asian	18 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	13 Participants n=4 Participants	8 Participants n=21 Participants	63 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants	4 Participants n=21 Participants	24 Participants n=10 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants	48 Participants n=7 Participants	55 Participants n=5 Participants	44 Participants n=4 Participants	54 Participants n=21 Participants	250 Participants n=10 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants	5 Participants n=21 Participants	23 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Randomization Strata: Background Statin Dose No Statin Therapy	30 Participants n=5 Participants	29 Participants n=7 Participants	31 Participants n=5 Participants	30 Participants n=4 Participants	30 Participants n=21 Participants	150 Participants n=10 Participants
Randomization Strata: Background Statin Dose Low- to Moderate-intensity Statin Therapy	27 Participants n=5 Participants	27 Participants n=7 Participants	26 Participants n=5 Participants	26 Participants n=4 Participants	26 Participants n=21 Participants	132 Participants n=10 Participants
Randomization Strata: Background Statin Dose High-intensity Statin Therapy	20 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	20 Participants n=4 Participants	20 Participants n=21 Participants	99 Participants n=10 Participants
Randomization Strata: Renal Function eGFR ≥60 ml/min/1.73 m^2	71 Participants n=5 Participants	72 Participants n=7 Participants	72 Participants n=5 Participants	71 Participants n=4 Participants	71 Participants n=21 Participants	357 Participants n=10 Participants
Randomization Strata: Renal Function eGFR <60 ml/min/1.73 m^2	6 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	24 Participants n=10 Participants
Baseline Low-density Lipoprotein Cholesterol (LDL-C)	116.5 mg/dL STANDARD_DEVIATION 37.0 • n=5 Participants	117.3 mg/dL STANDARD_DEVIATION 36.4 • n=7 Participants	123.7 mg/dL STANDARD_DEVIATION 35.1 • n=5 Participants	119.4 mg/dL STANDARD_DEVIATION 36.7 • n=4 Participants	120.7 mg/dL STANDARD_DEVIATION 28.3 • n=21 Participants	119.5 mg/dL STANDARD_DEVIATION 34.8 • n=10 Participants

PRIMARY outcome

Timeframe: Baseline and up to Week 8

Population: All randomized participants who received at least one dose of study intervention, had at least one observation for the analysis endpoint, and had baseline data were analyzed.

Outcome measures

Outcome measures
Measure	MK-0616 6 mg n=75 Participants Participants received 6 mg of MK-0616 orally QD for 8 weeks	MK-0616 12 mg n=75 Participants Participants received 12 mg of MK-0616 orally QD for 8 weeks	MK-0616 18 mg n=74 Participants Participants received 18 mg of MK-0616 orally QD for 8 weeks	MK-0616 30 mg n=73 Participants Participants received 30 mg of MK-0616 orally QD for 8 weeks	Placebo n=72 Participants Participants received MK-0616-matching placebo orally QD for 8 weeks
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 8	-40.0 Percentage Change Interval -45.2 to -34.8	-54.5 Percentage Change Interval -59.8 to -49.2	-57.9 Percentage Change Interval -63.2 to -52.6	-59.7 Percentage Change Interval -65.0 to -54.5	1.2 Percentage Change Interval -4.1 to 6.5

PRIMARY outcome

Timeframe: Up to approximately 17 Weeks

Population: All randomized participants who received at least one dose of study intervention were analyzed.

An AE was 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. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced at least one AE was reported.

Outcome measures

Outcome measures
Measure	MK-0616 6 mg n=77 Participants Participants received 6 mg of MK-0616 orally QD for 8 weeks	MK-0616 12 mg n=76 Participants Participants received 12 mg of MK-0616 orally QD for 8 weeks	MK-0616 18 mg n=76 Participants Participants received 18 mg of MK-0616 orally QD for 8 weeks	MK-0616 30 mg n=76 Participants Participants received 30 mg of MK-0616 orally QD for 8 weeks	Placebo n=75 Participants Participants received MK-0616-matching placebo orally QD for 8 weeks
Percentage of Participants Who Experienced One or More Adverse Events (AEs)	44.2 Percentage of Participants	39.5 Percentage of Participants	43.4 Percentage of Participants	42.1 Percentage of Participants	44.0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to approximately 9 Weeks

Population: All randomized participants who received at least one dose of study intervention were analyzed.

Outcome measures

Outcome measures
Measure	MK-0616 6 mg n=77 Participants Participants received 6 mg of MK-0616 orally QD for 8 weeks	MK-0616 12 mg n=76 Participants Participants received 12 mg of MK-0616 orally QD for 8 weeks	MK-0616 18 mg n=76 Participants Participants received 18 mg of MK-0616 orally QD for 8 weeks	MK-0616 30 mg n=76 Participants Participants received 30 mg of MK-0616 orally QD for 8 weeks	Placebo n=75 Participants Participants received MK-0616-matching placebo orally QD for 8 weeks
Percentage of Participants Who Discontinued Study Intervention Due to AEs	2.6 Percentage of Participants	0.0 Percentage of Participants	2.6 Percentage of Participants	2.6 Percentage of Participants	1.3 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and up to Week 8

Population: All randomized participants who received at least one dose of study intervention, had at least one observation for the analysis endpoint, and had baseline data were analyzed.

Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in ApoB. The least square mean and 95% CI were obtained from fitting a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in ApoB at week 8 was reported.

Outcome measures

Outcome measures
Measure	MK-0616 6 mg n=76 Participants Participants received 6 mg of MK-0616 orally QD for 8 weeks	MK-0616 12 mg n=75 Participants Participants received 12 mg of MK-0616 orally QD for 8 weeks	MK-0616 18 mg n=74 Participants Participants received 18 mg of MK-0616 orally QD for 8 weeks	MK-0616 30 mg n=74 Participants Participants received 30 mg of MK-0616 orally QD for 8 weeks	Placebo n=72 Participants Participants received MK-0616-matching placebo orally QD for 8 weeks
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 8	-32.8 Percentage Change Interval -37.6 to -27.9	-45.8 Percentage Change Interval -50.7 to -40.9	-48.7 Percentage Change Interval -53.6 to -43.8	-51.8 Percentage Change Interval -56.7 to -47.0	0.0 Percentage Change Interval -4.9 to 4.9

SECONDARY outcome

Timeframe: Baseline and up to Week 8

Population: All randomized participants who received at least one dose of study intervention, had at least one observation for the analysis endpoint, and had baseline data were analyzed.

Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in non-HDL-C. The least square mean and 95% CI were obtained from fitting a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in non-HDL-C at week 8 was reported.

Outcome measures

Outcome measures
Measure	MK-0616 6 mg n=74 Participants Participants received 6 mg of MK-0616 orally QD for 8 weeks	MK-0616 12 mg n=76 Participants Participants received 12 mg of MK-0616 orally QD for 8 weeks	MK-0616 18 mg n=74 Participants Participants received 18 mg of MK-0616 orally QD for 8 weeks	MK-0616 30 mg n=73 Participants Participants received 30 mg of MK-0616 orally QD for 8 weeks	Placebo n=72 Participants Participants received MK-0616-matching placebo orally QD for 8 weeks
Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 8	-34.4 Percentage Change Interval -39.6 to -29.2	-49.0 Percentage Change Interval -54.3 to -43.7	-51.8 Percentage Change Interval -57.1 to -46.4	-54.3 Percentage Change Interval -59.6 to -49.1	1.5 Percentage Change Interval -3.9 to 6.8

SECONDARY outcome

Timeframe: Week 8

Population: All randomized participants who received at least one dose of study intervention and had at least one observation for the analysis endpoint were analyzed.

LDL-C goal was defined as: LDL-C \<70 mg/dL (\<1.81 mmol/L) in participants with clinical atherosclerotic cardiovascular disease (ASCVD), LDL-C \<100 mg/dL (\<2.59 mmol/L) in participants with an ASCVD risk-equivalent and/or a 10-year risk of having an ASCVD event that is ≥7.5%, OR LDL-C \<130 mg/dL (\<3.37mmol/L) in participants with a 10-year risk of having an ASCVD event that is ≥5.0% and \<7.5%. The percentage of participants with LDL-C value at goal at week 8 were reported.

Outcome measures

Outcome measures
Measure	MK-0616 6 mg n=77 Participants Participants received 6 mg of MK-0616 orally QD for 8 weeks	MK-0616 12 mg n=76 Participants Participants received 12 mg of MK-0616 orally QD for 8 weeks	MK-0616 18 mg n=76 Participants Participants received 18 mg of MK-0616 orally QD for 8 weeks	MK-0616 30 mg n=76 Participants Participants received 30 mg of MK-0616 orally QD for 8 weeks	Placebo n=75 Participants Participants received MK-0616-matching placebo orally QD for 8 weeks
Percentage of Participants With LDL-C Value at Goal at Week 8	80.5 Percentage of Participants	85.5 Percentage of Participants	90.8 Percentage of Participants	90.8 Percentage of Participants	9.3 Percentage of Participants

Adverse Events

MK-0616 6 mg

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

MK-0616 12 mg

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

MK-0616 18 mg

Serious events: 2 serious events

Other events: 15 other events

Deaths: 1 deaths

MK-0616 30 mg

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MK-0616 6 mg n=77 participants at risk Participants received 6 mg of MK-0616 orally QD for 8 weeks	MK-0616 12 mg n=76 participants at risk Participants received 12 mg of MK-0616 orally QD for 8 weeks	MK-0616 18 mg n=76 participants at risk Participants received 18 mg of MK-0616 orally QD for 8 weeks	MK-0616 30 mg n=76 participants at risk Participants received 30 mg of MK-0616 orally QD for 8 weeks	Placebo n=75 participants at risk Participants received MK-0616-matching placebo orally QD for 8 weeks
Cardiac disorders Acute left ventricular failure	0.00% 0/77 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	1.3% 1/76 • Number of events 1 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/75 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.
General disorders Non-cardiac chest pain	1.3% 1/77 • Number of events 1 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/75 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.
Hepatobiliary disorders Cholecystitis	0.00% 0/77 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	1.3% 1/76 • Number of events 1 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/75 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations COVID-19	0.00% 0/77 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	1.3% 1/76 • Number of events 1 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/75 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/77 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	1.3% 1/76 • Number of events 1 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/75 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/77 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	1.3% 1/76 • Number of events 1 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/75 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/77 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	1.3% 1/76 • Number of events 1 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/75 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/77 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	1.3% 1/76 • Number of events 1 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/75 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/77 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	1.3% 1/76 • Number of events 1 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/75 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.
Vascular disorders Deep vein thrombosis	0.00% 0/77 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	1.3% 1/76 • Number of events 1 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/75 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.

Other adverse events

Other adverse events
Measure	MK-0616 6 mg n=77 participants at risk Participants received 6 mg of MK-0616 orally QD for 8 weeks	MK-0616 12 mg n=76 participants at risk Participants received 12 mg of MK-0616 orally QD for 8 weeks	MK-0616 18 mg n=76 participants at risk Participants received 18 mg of MK-0616 orally QD for 8 weeks	MK-0616 30 mg n=76 participants at risk Participants received 30 mg of MK-0616 orally QD for 8 weeks	Placebo n=75 participants at risk Participants received MK-0616-matching placebo orally QD for 8 weeks
Gastrointestinal disorders Diarrhoea	6.5% 5/77 • Number of events 5 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	1.3% 1/76 • Number of events 1 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	3.9% 3/76 • Number of events 3 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	1.3% 1/76 • Number of events 2 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	1.3% 1/75 • Number of events 1 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.
Gastrointestinal disorders Dyspepsia	1.3% 1/77 • Number of events 1 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	6.6% 5/76 • Number of events 5 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	3.9% 3/76 • Number of events 3 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	1.3% 1/75 • Number of events 1 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.
Gastrointestinal disorders Nausea	1.3% 1/77 • Number of events 1 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	1.3% 1/76 • Number of events 1 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	5.3% 4/76 • Number of events 4 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	2.6% 2/76 • Number of events 2 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/75 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.
General disorders Fatigue	0.00% 0/77 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	3.9% 3/76 • Number of events 3 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	1.3% 1/76 • Number of events 1 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/76 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	6.7% 5/75 • Number of events 5 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations COVID-19	7.8% 6/77 • Number of events 6 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	1.3% 1/76 • Number of events 1 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	6.6% 5/76 • Number of events 5 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	5.3% 4/76 • Number of events 4 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	9.3% 7/75 • Number of events 7 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/77 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	5.3% 4/76 • Number of events 5 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	1.3% 1/76 • Number of events 1 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	2.6% 2/76 • Number of events 2 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.	1.3% 1/75 • Number of events 1 • Up to approximately 17 weeks The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.

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