Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-2060 · 6 trials · 7 indications
An AVG thrombosis event is defined as the sudden occlusion of the participant's AVG requiring thrombectomy/thrombolysis, or clinical evidence of thrombosis with surgical, radiological or pathological conformation of an AVG thrombosis. A blinded independent clinical adjudication committee (CAC) adjudicated AVG thrombosis events. A time-to-event methodology was used to evaluate the results. The incidence rate is presented.
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. The number of participants that experience an AE will be reported.
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. The number of participants that discontinue the study due to an AE will be reported.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The number of participants who experienced an AE is reported.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The number of participants who discontinued study due to an AE is reported.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Blood was collected to determine the AUC0-inf of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma.
Blood was collected to determine the AUC0-168 of MK-2060 in plasma.
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.
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.
Blood was collected at pre-specified time points to determine the Cmax of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma.
Blood was collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma.
Blood was to be collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma.
Blood was to be collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma.
Blood was collected at pre-specified time points to determine the Tmax of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma.
Blood was collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma.
Blood was collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.
Blood was collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma
Blood was to be collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma
Blood was to be collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma
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 non major bleeding or major bleeding.
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.
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.
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. The percentage of participants that experienced an AE was summarized.
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. The percentage of participants who experienced an AE was summarized.
A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants who experienced an SAE was summarized.
An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants who experienced an SAE was summarized.
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. The solicited systemic AEs assessed included but not limited to fever, vital sign (VS) changes (tachycardia/hypotension), pruritis, urticarial (hives), lip swelling, angioedema, bronchospasm, stridor, hoarseness, and shortness of breath.
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. The solicited systemic AEs assessed included but not limited to fever, vital sign (VS) changes (tachycardia/hypotension), pruritis, urticarial (hives), lip swelling, angioedema, bronchospasm, stridor, hoarseness, and shortness of breath.
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. The solicited injection-site AEs assessed were pain, tenderness, erythema/redness, and induration/swelling.
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. The solicited injection-site AEs assessed were pain, tenderness, erythema/redness, and induration/swelling.
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. The percentage of participants that discontinued the study due to an AE was summarized.
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. The percentage of participants that had study drug discontinued regardless of study completion status was summarized.
| Arm | Type | Description |
|---|---|---|
| MK-2060 20 mg | EXPERIMENTAL | MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1 |
| MK-2060 6 mg | EXPERIMENTAL | MK-2060 6 mg administered via intravenous (IV) infusion during dialysis as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1 |
| Placebo | PLACEBO_COMPARATOR | Placebo (normal saline) administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1 |
| Panel A: MK-2060 IV (20 minutes) | EXPERIMENTAL | Participants will receive a single dose of MK-2060 via intravenous (IV) infusion over 20 minutes on Day 1. |
| Panel B: MK-2060 IV (10 minutes) | EXPERIMENTAL | Participants will receive a single dose of MK-2060 via IV infusion over 10 minutes on Day 1. |
| Panel C: MK-2060 IV (5 minutes) | EXPERIMENTAL | Participants will receive a single dose of MK-2060 via syringe over 5 minutes on Day 1. |
| Panel D: MK-2060 IV (2.5 minutes) | EXPERIMENTAL | Participants will receive a single dose of MK-2060 via syringe over 2.5 minutes on Day 1. |
| Panel E: MK-2060 IV (1 minute) | EXPERIMENTAL | Participants will receive a single dose of MK-2060 via syringe over 1 minute on Day 1. |
| MK-2060 | EXPERIMENTAL | Participants receive MK-2060 50 mg via a single intravenous (IV) infusion over 60-minutes. |
| MK-2060 30 mg | EXPERIMENTAL | Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1. |
| Part 1: Panel A- MK-2060 (8 mg) | EXPERIMENTAL | Participants will receive a single 8-mg dose of MK-2060 via intravenous (IV) infusion. |
| Part 1: Panel B- MK-2060 (20 mg) | EXPERIMENTAL | Participants will receive a single 20-mg dose of MK-2060 via IV infusion. |
| Part 1: Panel C- MK-2060 (40 mg) | EXPERIMENTAL | Participants will receive a single 40-mg dose of MK-2060 via IV infusion. |
| Part 1: Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo via IV infusion. |
| Part 2: MK-2060 25-mg Loading/ 25-mg Maintenance | EXPERIMENTAL | Participants will receive three doses of up to 25 mg MK-2060 via IV infusion in the first week (Week 1), followed by a single dose of up to 25 mg MK-2060 via IV infusion weekly for 3 weeks (Weeks 2-4) |
| Part 2: Placebo | PLACEBO_COMPARATOR | Participants will receive three doses of placebo via IV infusion in the first week and then a single dose of placebo via IV infusion weekly for 3 weeks (Weeks 2-4) |
| Name | Type | Description |
|---|---|---|
| MK-2060 | DRUG | MK-2060 lyophilized powder diluted in normal saline and administered via IV infusion |
| Placebo | DRUG | Normal saline administered via IV infusion |
Inclusion Criteria: * Current diagnosis of ESRD. * Receiving hemodialysis (including hemodiafiltration) ≥3 times per week for a minimum of 3 hours per session via a mature normally functioning, uninfected AVG with at least 75% of the sessions meeting these criteria over the 4 weeks prior to randomi...
MK-2060 is an investigational monoclonal antibody developed by Merck & Company, Inc. (ticker MRK) for nephrology indications. It is being studied in end-stage renal disease, renal dialysis, and venous thrombosis. The program is in Phase 2 development, and the clinical trials completed to date have enrolled a total of 549 participants.
MK-2060 is being developed for use in end-stage renal disease and renal dialysis, where patients face elevated thrombotic risk, as well as in venous thrombosis. It remains investigational and has not been established as a treatment. Studies have enrolled adults with chronic kidney disease and end-stage kidney disease, including dialysis patients.
MK-2060 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsors the clinical program, including the Phase 1 studies conducted in the United States, Japan, Israel, and Romania, and the Phase 2 development stage for the asset in nephrology indications.
MK-2060 is in Phase 2 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA. Four clinical trials have been completed, and no trials are currently active. The completed studies include Phase 1 trials in healthy participants and in patients with chronic and end-stage kidney disease.
Completed MK-2060 trials include NCT06582602 in healthy participants with venous thrombosis, NCT05769595 in older Japanese participants on dialysis, NCT05656040 in participants with chronic and/or end-stage kidney disease, and NCT05335005, which studied co-administration with clopidogrel in end-stage renal disease. All four were randomized, double-blind, and placebo-controlled.
Across the four completed MK-2060 clinical trials, 549 participants were enrolled in total. Individual study sizes ranged from 12 participants in the clopidogrel co-administration study to 23 in the healthy participant study. All trials were randomized, double-blind, and placebo-controlled, and none were biomarker-selected.