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) - P2 | "Approximately 36% of the participants received daily low-dose aspirin, 58% had diabetes, and 19% had a history of coronary artery disease. The results from this phase 2b trial will provide important insights into the efficacy and safety of FXI inhibition with MK-2060 for the prevention of AVG thrombosis in patients with ESKD on haemodialysis. Findings from this study could potentially inform future anticoagulation strategies regarding the balance between thrombosis prevention and bleeding risk with FXI inhibition."

Clinical • Late-breaking abstract • P2b data • Cardiovascular • Coronary Artery Disease • Diabetes • Diabetic Nephropathy • Hematological Disorders • Metabolic Disorders • Nephrology • Thrombosis

A Study of MK-2060 in Healthy Participants (MK-2060-016) (clinicaltrials.gov) - P1 | N=23 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed | N=64 ➔ 23

Enrollment change • Trial completion • 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