Trial Outcomes & Findings for A Study of MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease (MK-2060-011) (NCT NCT05656040)

Results Overview

Bleeding related AEs will include any sign or symptom of bleeding, even if not requiring intervention by a medical/healthcare professional, as well as clinically relevant nonmajor bleeding or major bleeding.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

14 participants

Primary outcome timeframe

Up to approximately 104 days

Results posted on

2025-09-10

Participant Flow

Adult participants with stage 4 chronic kidney disease (CKD4) were recruited.

Participant milestones

Participant milestones
Measure	MK-2060 30 mg Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1.	Placebo Participants receive placebo (normal saline) administered as a single subcutaneous dose on Day 1.
Overall Study STARTED	11	3
Overall Study COMPLETED	11	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease (MK-2060-011)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-2060 30 mg n=11 Participants Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1.	Placebo n=3 Participants Participants receive placebo (normal saline) administered as a single subcutaneous dose on Day 1.	Total n=14 Participants Total of all reporting groups
Age, Continuous	71.1 Years STANDARD_DEVIATION 9.4 • n=5 Participants	59.0 Years STANDARD_DEVIATION 17.4 • n=7 Participants	68.5 Years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 104 days

Population: All treated participants in Part 1 are included.

Bleeding related AEs will include any sign or symptom of bleeding, even if not requiring intervention by a medical/healthcare professional, as well as clinically relevant nonmajor bleeding or major bleeding.

Outcome measures

Outcome measures
Measure	MK-2060 30 mg n=11 Participants Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1.	Placebo n=3 Participants Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 1.
Part 1: Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to approximately 144 days

Population: Part 2 was never initiated.

Bleeding related AEs include any sign or symptom of bleeding, even if not requiring intervention by a medical/healthcare professional, as well as clinically relevant nonmajor bleeding or major bleeding.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to approximately 104 days

Population: Part 3 was never initiated.

Bleeding related AEs will include any sign or symptom of bleeding, even if not requiring intervention by a medical/healthcare professional, as well as clinically relevant nonmajor bleeding or major bleeding.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to approximately 104 days

Population: All treated participants in Part 1 are included.

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

Outcome measures

Outcome measures
Measure	MK-2060 30 mg n=11 Participants Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1.	Placebo n=3 Participants Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 1.
Part 1: Number of Participants Who Experience One or More AEs	5 Participants	2 Participants

PRIMARY outcome

Timeframe: Up to approximately 144 days

Population: Part 2 was never initiated.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to approximately 104 days

Population: Part 3 was never initiated.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to approximately 104 days

Population: All treated participants in Part 1 are included.

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

Outcome measures

Outcome measures
Measure	MK-2060 30 mg n=11 Participants Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1.	Placebo n=3 Participants Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 1.
Part 1: Number of Participants Who Discontinue Study Treatment to an AE	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to approximately 144 days

Population: Part 2 was never initiated.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to approximately 104 days

Population: Part 3 was never initiated.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose

Population: All Part 1 participants treated with MK-2060 and who have data available are included.

Blood was collected to determine the AUC0-inf of MK-2060 in plasma.

Outcome measures

Outcome measures
Measure	MK-2060 30 mg n=11 Participants Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1.	Placebo Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 1.
Part 1: Area Under the Concentration-Time Curve From 0 to Infinity (AUC0-inf) of MK-2060	14300 hr*nM Geometric Coefficient of Variation 40.9	—

PRIMARY outcome

Timeframe: Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose

Population: Part 2 was never initiated.

Blood was to be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose

Population: Part 3 was never initiated.

Blood was to be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Pre-dose, 1, 12, 24, 48, 120, and 168 hours post-dose

Population: All Part 1 participants treated with MK-2060 and who have data available are included.

Blood was collected to determine the AUC0-168 of MK-2060 in plasma.

Outcome measures

Outcome measures
Measure	MK-2060 30 mg n=11 Participants Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1.	Placebo Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 1.
Part 1: Area Under the Concentration-Time Curve From Time 0 to 168 Hours (AUC0-168) of MK-2060	727 hr*nM Geometric Coefficient of Variation 103.3	—

PRIMARY outcome

Timeframe: Pre-dose, 24, 72, and 168 hours post-dose

Population: Part 2 was never initiated.

Blood was to be collected at pre-specified time points to determine the AUC0-168 of MK-2060 in plasma from 0 to 168 hours.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Pre-dose, 1, 12, 24, 48, 120, and 168 hours post-dose

Population: Part 3 was never initiated.

Blood was to be collected at pre-specified time points to determine the AUC0-168 of MK-2060 in plasma from 0 to 168 hours.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose

Population: All Part 1 participants treated with MK-2060 and who have data available are included.

Blood was collected at pre-specified time points to determine the Cmax of MK-2060 in plasma.

Outcome measures

Outcome measures
Measure	MK-2060 30 mg n=11 Participants Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1.	Placebo Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 1.
Part 1: Maximum Plasma Concentration (Cmax) of MK-2060	11.3 nM Geometric Coefficient of Variation 38.8	—

PRIMARY outcome

Timeframe: Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose

Population: Part 2 was never initiated.

Blood was to be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose

Population: Part 3 was never initiated.

Blood was to be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 168 hours post-dose

Population: All Part 1 participants treated with MK-2060 and who have data available are included.

Blood was collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma.

Outcome measures

Outcome measures
Measure	MK-2060 30 mg n=11 Participants Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1.	Placebo Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 1.
Part 1: Plasma Concentration at 168 Hours (C168) of MK-2060	7.19 nM Geometric Coefficient of Variation 79.7	—

PRIMARY outcome

Timeframe: 168 hours post-dose

Population: Part 2 was never initiated.

Blood was to be collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 168 hours post-dose

Population: Part 3 was never initiated.

Blood was to be collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose

Population: All Part 1 participants treated with MK-2060 and who have data available are included.

Blood was collected at pre-specified time points to determine the Tmax of MK-2060 in plasma.

Outcome measures

Outcome measures
Measure	MK-2060 30 mg n=11 Participants Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1.	Placebo Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 1.
Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-2060	312.82 hours Interval 143.67 to 648.88	—

PRIMARY outcome

Timeframe: Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose

Population: Part 2 was never initiated.

Blood was to be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose

Population: Part 3 was never initiated.

Blood was to be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose

Population: All Part 1 participants treated with MK-2060 and who have data available are included.

Blood was collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma.

Outcome measures

Outcome measures
Measure	MK-2060 30 mg n=11 Participants Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1.	Placebo Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 1.
Part 1: Terminal Half Life (t1/2) of MK-2060	677 hours Geometric Coefficient of Variation 26.3	—

PRIMARY outcome

Timeframe: Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose

Population: Part 2 was never initiated.

Blood was to be collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose

Population: Part 3 was never initiated.

Blood was to be collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose

Population: All Part 1 participants treated with MK-2060 and who have data available are included.

Blood was collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.

Outcome measures

Outcome measures
Measure	MK-2060 30 mg n=11 Participants Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1.	Placebo Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 1.
Part 1: Apparent Total Clearance (CL/F) of MK-2060	0.0141 Liters/hour Geometric Coefficient of Variation 40.9	—

PRIMARY outcome

Timeframe: Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose

Population: Part 2 was never initiated.

Blood was to be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose

Population: Part 3 was never initiated.

Blood was to be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose

Population: All Part 1 participants treated with MK-2060 and who have data available are included.

Blood was collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma

Outcome measures

Outcome measures
Measure	MK-2060 30 mg n=11 Participants Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1.	Placebo Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 1.
Part 1: Apparent Volume of Distribution (Vz/F) of MK-2060	13.8 Liters Geometric Coefficient of Variation 39.6	—

PRIMARY outcome

Timeframe: Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose

Population: Part 2 was never initiated.

Blood was to be collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose

Population: Part 3 was never initiated.

Blood was to be collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90)

Population: All Part 1 participants treated with MK-2060 and who have data available are included.

Blood was collected at pre-specified time points to determine the aPTT of MK-2060 in plasma. Positive and negative scores indicate increases and decreases, respectively, in aPTT compared to baseline.

Outcome measures

Outcome measures
Measure	MK-2060 30 mg n=9 Participants Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1.	Placebo n=3 Participants Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 1.
Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 Post Study (Day 90)	1.026 Mean fold change from baseline Standard Error 0.044	1.129 Mean fold change from baseline Standard Error 0.064
Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 Day 8	1.202 Mean fold change from baseline Standard Error 0.059	1.08 Mean fold change from baseline Standard Error 0.093
Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 Day 1: 1 Hour Postdose	1.047 Mean fold change from baseline Standard Error 0.028	0.977 Mean fold change from baseline Standard Error 0.037
Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 Day 1: 12 Hours Postdose	1.044 Mean fold change from baseline Standard Error 0.03	0.994 Mean fold change from baseline Standard Error 0.017
Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 Day 2	1.05 Mean fold change from baseline Standard Error 0.021	0.971 Mean fold change from baseline Standard Error 0.02
Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 Day 3	1.137 Mean fold change from baseline Standard Error 0.04	1.032 Mean fold change from baseline Standard Error 0.033
Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 Day 6	1.219 Mean fold change from baseline Standard Error 0.059	1.075 Mean fold change from baseline Standard Error 0.081
Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 Day 11	1.157 Mean fold change from baseline Standard Error 0.063	1.08 Mean fold change from baseline Standard Error 0.084
Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 Day 14	1.128 Mean fold change from baseline Standard Error 0.042	1.102 Mean fold change from baseline Standard Error 0.114
Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 Day 21	1.114 Mean fold change from baseline Standard Error 0.037	1.01 Mean fold change from baseline Standard Error 0.075
Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 Day 28	1.07 Mean fold change from baseline Standard Error 0.048	1.012 Mean fold change from baseline Standard Error 0.049
Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 Day 60	1.101 Mean fold change from baseline Standard Error 0.038	1.053 Mean fold change from baseline Standard Error 0.115

SECONDARY outcome

Timeframe: Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90)

Population: Part 2 was never initiated.

Blood was to be collected at pre-specified time points to determine the aPTT of MK-2060 in plasma.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90)

Population: Part 3 was never initiated.

Blood was to be collected at pre-specified time points to determine the aPTT of MK-2060 in plasma.

Outcome measures

Outcome data not reported

Adverse Events

MK-2060 30 mg

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MK-2060 30 mg n=11 participants at risk Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1.	Placebo n=3 participants at risk Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 1.
Blood and lymphatic system disorders Anaemia	9.1% 1/11 • Number of events 1 • Up to approximately 104 days All treated participants are included.	0.00% 0/3 • Up to approximately 104 days All treated participants are included.
Cardiac disorders Cardiac failure congestive	9.1% 1/11 • Number of events 1 • Up to approximately 104 days All treated participants are included.	0.00% 0/3 • Up to approximately 104 days All treated participants are included.
Renal and urinary disorders Acute kidney injury	9.1% 1/11 • Number of events 1 • Up to approximately 104 days All treated participants are included.	0.00% 0/3 • Up to approximately 104 days All treated participants are included.

Other adverse events

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 If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
Publication restrictions are in place

Restriction type: OTHER

Measure	MK-2060 30 mg n=11 participants at risk Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1.	Placebo n=3 participants at risk Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 1.
Ear and labyrinth disorders Eustachian tube obstruction	0.00% 0/11 • Up to approximately 104 days All treated participants are included.	33.3% 1/3 • Number of events 1 • Up to approximately 104 days All treated participants are included.
Ear and labyrinth disorders Vertigo positional	9.1% 1/11 • Number of events 1 • Up to approximately 104 days All treated participants are included.	0.00% 0/3 • Up to approximately 104 days All treated participants are included.
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • Number of events 1 • Up to approximately 104 days All treated participants are included.	0.00% 0/3 • Up to approximately 104 days All treated participants are included.
Gastrointestinal disorders Nausea	9.1% 1/11 • Number of events 1 • Up to approximately 104 days All treated participants are included.	0.00% 0/3 • Up to approximately 104 days All treated participants are included.
Gastrointestinal disorders Vomiting	9.1% 1/11 • Number of events 1 • Up to approximately 104 days All treated participants are included.	0.00% 0/3 • Up to approximately 104 days All treated participants are included.
General disorders Asthenia	9.1% 1/11 • Number of events 1 • Up to approximately 104 days All treated participants are included.	0.00% 0/3 • Up to approximately 104 days All treated participants are included.
General disorders Injection site erythema	9.1% 1/11 • Number of events 1 • Up to approximately 104 days All treated participants are included.	0.00% 0/3 • Up to approximately 104 days All treated participants are included.
Infections and infestations Respiratory tract infection	9.1% 1/11 • Number of events 1 • Up to approximately 104 days All treated participants are included.	0.00% 0/3 • Up to approximately 104 days All treated participants are included.
Injury, poisoning and procedural complications Meniscus injury	9.1% 1/11 • Number of events 1 • Up to approximately 104 days All treated participants are included.	0.00% 0/3 • Up to approximately 104 days All treated participants are included.
Investigations Occult blood positive	0.00% 0/11 • Up to approximately 104 days All treated participants are included.	33.3% 1/3 • Number of events 1 • Up to approximately 104 days All treated participants are included.
Investigations White blood cell count increased	0.00% 0/11 • Up to approximately 104 days All treated participants are included.	33.3% 1/3 • Number of events 1 • Up to approximately 104 days All treated participants are included.
Musculoskeletal and connective tissue disorders Back pain	9.1% 1/11 • Number of events 1 • Up to approximately 104 days All treated participants are included.	0.00% 0/3 • Up to approximately 104 days All treated participants are included.
Musculoskeletal and connective tissue disorders Muscle spasms	9.1% 1/11 • Number of events 1 • Up to approximately 104 days All treated participants are included.	0.00% 0/3 • Up to approximately 104 days All treated participants are included.
Nervous system disorders Tremor	9.1% 1/11 • Number of events 1 • Up to approximately 104 days All treated participants are included.	0.00% 0/3 • Up to approximately 104 days All treated participants are included.
Renal and urinary disorders Acute kidney injury	9.1% 1/11 • Number of events 1 • Up to approximately 104 days All treated participants are included.	0.00% 0/3 • Up to approximately 104 days All treated participants are included.
Skin and subcutaneous tissue disorders Pruritus	9.1% 1/11 • Number of events 1 • Up to approximately 104 days All treated participants are included.	0.00% 0/3 • Up to approximately 104 days All treated participants are included.