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

NCT05656040 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 2060-011MK-2060-011
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 4

Brief Summary

This was intended as a three-part study of MK-2060 in participants with chronic and/or end-stage kidney disease (Parts 2 and 3 were not initiated due to reasons not related to safety). The purpose of Part 1 of the study was to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous dose of MK-2060 in stage 4 chronic kidney disease (CKD4) \[Part2 was intended to evaluate multiple subcutaneous doses in CKD4 participants and Part 3 was intended to evaluate a single subcutaneous dose of MK-2060 in participants with end-stage kidney disease (ESRD)\]. The primary hypothesis for Part 1 was that the true geometric mean of the area under the concentration-time curve from 0 to infinity (AUC0-inf) after a single-dose of MK-2060 in adult CKD4 participants would be at least 11300 nM\*hr.

Conditions

End-Stage Renal Disease; End-Stage Kidney Disease; Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (33)

• Part 1: Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE)

  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.

  Up to approximately 104 days

• Part 2: Number of Participants Who Experience One or More Bleeding Related AEs

  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.

  Up to approximately 144 days

• Part 3: Number of Participants Who Experience One or More Bleeding Related AEs

  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.

  Up to approximately 104 days

• Part 1: Number of Participants Who Experience One or More AEs

  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.

  Up to approximately 104 days

• Part 2: Number of Participants Who Experience One or More AEs

  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.

  Up to approximately 144 days

• Part 3: Number of Participants Who Experience One or More AEs

  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.

  Up to approximately 104 days

• Part 1: Number of Participants Who Discontinue Study Treatment to an AE

  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.

  Up to approximately 104 days

• Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE

  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.

  Up to approximately 144 days

• Part 3: Number of Participants Who Discontinue Study Due to an AE

  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.

  Up to approximately 104 days

• Part 1: Area Under the Concentration-Time Curve From 0 to Infinity (AUC0-inf) of MK-2060

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

  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

• Part 2: AUC0-inf of MK-2060

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

  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

• Part 3: AUC0-inf of MK-2060

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

  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

• Part 1: Area Under the Concentration-Time Curve From Time 0 to 168 Hours (AUC0-168) of MK-2060

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

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

• Part 2: AUC0-168 of MK-2060

  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.

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

• Part 3: AUC0-168 of MK-2060

  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.

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

• Part 1: Maximum Plasma Concentration (Cmax) of MK-2060

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

  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

• Part 2: Cmax of MK-2060

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

  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

• Part 3: Cmax of MK-2060

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

  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

• Part 1: Plasma Concentration at 168 Hours (C168) of MK-2060

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

  168 hours post-dose

• Part 2: C168 of MK-2060

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

  168 hours post-dose

• Part 3: C168 of MK-2060

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

  168 hours post-dose

• Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-2060

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

  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

• Part 2: Tmax of MK-2060

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

  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

• Part 3: Tmax of MK-2060

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

  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

• Part 1: Terminal Half Life (t1/2) of MK-2060

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

  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

• Part 2: t1/2 of MK-2060

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

  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

• Part 3: t1/2 of MK-2060

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

  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

• Part 1: Apparent Total Clearance (CL/F) of MK-2060

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

  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

• Part 2: CL/F of MK-2060

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

  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

• Part 3: CL/F of MK-2060

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

  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

• Part 1: Apparent Volume of Distribution (Vz/F) of MK-2060

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

  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

• Part 2: Vz/F of MK-2060

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

  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

• Part 3: Vz/F of MK-2060

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

  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

Secondary Outcomes (3)

• Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060

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

• Part 2: Percent Change From Baseline in aPTT of MK-2060

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

• Part 3: Percent Change From Baseline in aPTT of MK-2060

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

Study Arms (2)

MK-2060 30 mg

EXPERIMENTAL

Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1.

Biological: MK-2060

Placebo

PLACEBO COMPARATOR

Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 1.

Drug: Placebo

Interventions

MK-2060 BIOLOGICAL

MK-2060 lyophilized powder diluted in normal saline and administered subcutaneously

MK-2060 30 mg

Placebo DRUG

Normal saline administered subcutaneously

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At the time of screening, has stage 4 or 5 chronic kidney disease (Parts 1 and 2) or end-state kidney disease on peritoneal dialysis (Part 3).
• Has a body mass index (BMI) ≥ 18 and ≤ 45 kg/m\^2.

You may not qualify if:

• Has a history of cancer, including adenocarcinoma, except adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignances which have been successfully treated ≥ 5 years prior to prestudy with appropriate follow-up.
• Has a history of deep vein thrombosis or pulmonary embolism, a history of vascular access thrombosis within 1 month prior to enrollment, or has a personal or family history of bleeding disorder.
• Has a history of gastrointestinal (GI) bleeding, duodenal polyps, or gastric ulcer in the last 5 years or severe hemorrhoidal bleed in the last 3 months.
• Has a history of or current frequent epistaxis within the last 3 months or active gingivitis.
• Has ongoing anticoagulant therapy or antiplatelet therapy. Aspirin is permitted.
• Has planned significant dental procedures at the time of screening or pre-dose or other planned surgical procedures within duration of participation of study.
• Is positive for hepatitis B surface antigen or human immunodeficiency virus (HIV).
• Has had major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pre-study visit.
• Has a history (participant recall) of receiving any human immunoglobulin preparation such as intravenous immunoglobulin (IVIG) or RhoGAM within the last year.
• Has a history (participant recall) of receiving any biological therapy (including human blood products or monoclonal antibodies; excluding erythropoietin and insulin) within the last 3 months or vaccination within the last 1 month, except the seasonal flu and pneumococcal vaccine or COVID-19 vaccine.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (4)

Velocity Clinical Research, New Smyrna Beach ( Site 0003)

Edgewater, Florida, 32132, United States

Location

Advanced Pharma CR, LLC ( Site 0006)

Miami, Florida, 33147, United States

Location

Genesis Clinical Research, LLC ( Site 0004)

Tampa, Florida, 33603, United States

Location

Alliance for Multispecialty Research, LLC ( Site 0002)

Knoxville, Tennessee, 37920, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 19, 2022
• Study Start: February 8, 2023
• Primary Completion: August 12, 2024
• Study Completion: August 12, 2024
• Last Updated: September 10, 2025
• Results First Posted: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (4)