Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-2060 · 7 trials · 8 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.
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 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.
A bleeding related AE includes any sign or symptom of bleeding even if not requiring intervention by a medical/ healthcare professional, to clinically-relevant non major 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.
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. |
| Panel A: MK-2060 Dose 1 | EXPERIMENTAL | MK-2060 dose 1 was administered as a single intravenous (IV) infusion dose on Day 1. |
| Panel B: MK-2060 Dose 2 | EXPERIMENTAL | MK-2060 dose 2 was administered as a single IV infusion dose on Day 1. There was at least a 21-day period between dosing in Panel A and B. |
| Panel C: MK-2060 Dose 3 | EXPERIMENTAL | MK-2060 dose 3 was administered as a single IV infusion dose on Day 1. There was at least a 21-day period between dosing in Panel B and C. |
| 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 being studied for use in patients with end-stage renal disease (ESRD) who are receiving hemodialysis. It is being evaluated to address complications related to renal dialysis and venous thrombosis in this patient population.
MK-2060 is an anti-factor XI monoclonal antibody. It targets factor XI, a protein involved in blood clotting, to potentially reduce thrombotic events without increasing bleeding risk in patients with end-stage renal disease on hemodialysis.
MK-2060 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK on the New York Stock Exchange. Merck is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
MK-2060 is currently in Phase 2 clinical development. It has completed Phase 1 trials and one Phase 2 trial, with all trials completed to date. The drug remains investigational and has not been approved by regulatory authorities.
MK-2060 has been studied in several completed trials, including NCT03873038, a Phase 1 safety and pharmacokinetics study in older ESRD patients on hemodialysis; NCT05027074, a Phase 2 global study in ESRD patients receiving hemodialysis; NCT05335005, a Phase 1 co-administration study with clopidogrel; and NCT05656040, a Phase 1 study in chronic and/or end-stage kidney disease.
Yes, MK-2060 is described as an anti-factor XI monoclonal antibody in its clinical trial titles. It is designed to target factor XI, a coagulation protein, and is being investigated for its potential role in managing thrombotic risk in patients with kidney disease.