MK-2060 / Merck (MSD) - LARVOL DELTA

A phase 2b trial of efficacy and safety of factor XI inhibition with MK-2060 for preventing arteriovenous graft thrombosis in haemodialysis patients (ERA 2025) - No abstract available

Clinical • Late-breaking abstract • P2b data • Cardiovascular • Hematological Disorders • Thrombosis

Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007) (clinicaltrials.gov) - P2 | N=506 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Nephrology • Thrombosis

Single-Ascending Dose Study of MK-2060 in Healthy Chinese Male Adult Participants (MK-2060-009) (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

A Study of MK-2060 in Healthy Participants (MK-2060-016) (clinicaltrials.gov) - P1 | N=64 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Hematological Disorders • Thrombosis

Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007) (clinicaltrials.gov) - P2 | N=506 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Oct 2024 ➔ Feb 2025 | Trial primary completion date: Jul 2024 ➔ Oct 2024

Trial completion date • Trial primary completion date • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Nephrology • Thrombosis

A Study of MK-2060 in Healthy Participants (MK-2060-016) (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Hematological Disorders • Thrombosis

A Study of MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease (MK-2060-011) (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed | N=33 ➔ 14

Enrollment change • Trial completion • Chronic Kidney Disease • Nephrology • Renal Disease

A Study of MK-2060 in Healthy Participants (MK-2060-016) (clinicaltrials.gov) - P1 | N=64 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1 trial • Cardiovascular • Hematological Disorders • Thrombosis • Venous Thromboembolism

A Study of MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease (MK-2060-011) (clinicaltrials.gov) - P1 | N=33 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Kidney Disease • Nephrology • Renal Disease

Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012) (clinicaltrials.gov) - P1 | N=17 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Chronic Kidney Disease • Nephrology • Renal Disease

A Study of MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease (MK-2060-011) (clinicaltrials.gov) - P1 | N=33 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | N=12 ➔ 33

Enrollment change • Chronic Kidney Disease • Nephrology • Renal Disease

A Study of MK-2060 in Participants With Chronic Kidney Disease (MK-2060-011) (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Feb 2024 ➔ Aug 2024 | Trial primary completion date: Feb 2024 ➔ Aug 2024

Trial completion date • Trial primary completion date • Chronic Kidney Disease • Nephrology • Renal Disease

Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012) (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Kidney Disease • Nephrology • Renal Disease

Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012) (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Nephrology • Renal Disease

Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012) (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1 trial • Chronic Kidney Disease • Nephrology • Renal Disease

Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007) (clinicaltrials.gov) - P2 | N=489 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Nephrology • Thrombosis

MK-2060 and Clopidogrel Co-administration Safety and Tolerability Study in Participants With End-Stage Renal Disease (ESRD) (MK-2060-008) (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Chronic Kidney Disease • Nephrology • Renal Disease

A Study of MK-2060 in Participants With Chronic Kidney Disease (MK-2060-011) (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Nephrology • Renal Disease

A Study of MK-2060 in Participants With Chronic Kidney Disease (MK-2060-011) (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1 trial • Chronic Kidney Disease • Nephrology • Renal Disease

Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007) (clinicaltrials.gov) - P2 | N=489 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Apr 2023 ➔ Oct 2024 | Trial primary completion date: Mar 2023 ➔ Jul 2024

Clinical data • Trial completion date • Trial primary completion date • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Nephrology • Thrombosis

MK-2060 and Clopidogrel Co-administration Safety and Tolerability Study in Participants With End-Stage Renal Disease (ESRD) (MK-2060-008) (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2023 ➔ Jan 2023 | Trial primary completion date: Sep 2023 ➔ Jan 2023

Enrollment closed • Trial completion date • Trial primary completion date • Chronic Kidney Disease • Nephrology • Renal Disease

"@Alcon to Buy @AeriePharma for About USD 753 Million. FDA Grants Fast Track Designation to @Merck's MK-2060 for ESRD. Aktis Oncology Raises USD 84 Million to Advance Novel Targeted Alpha Radiopharmaceuticals. (2/3)" (@delve_insight)

Fast track designation • FDA event • Chronic Kidney Disease • Oncology • Renal Disease

Merck Receives Fast Track Designation from the U.S. FDA for MK-2060, an Investigational Anticoagulant Therapy (Businesswire) - "Merck...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Merck’s investigational anticoagulant therapy MK-2060 for the reduction in risk of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD). According to the FDA, Fast Track is a process designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fulfill an unmet medical need."

Fast track designation • Thrombosis

"$MRK Merck Receives Fast Track Designation from the U.S. FDA for MK-2060, an Investigational Anticoagulant Therapy https://t.co/BlZjIm3saY" (@stock_titan)

Fast track designation • FDA event

MK-2060 and Clopidogrel Co-administration Safety and Tolerability Study in Participants With End-Stage Renal Disease (ESRD) (MK-2060-008) (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Nephrology • Renal Disease