NCT05656040

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

A Single-and Multiple Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Subcutaneous MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	MK-2060	MK-2060 lyophilized powder diluted in normal saline and administered subcutaneously
DRUG	Placebo	Normal saline administered subcutaneously

Timeline

• Start date: 2023-02-08
• Primary completion: 2024-08-12
• Completion: 2024-08-12
• First posted: 2022-12-19
• Last updated: 2025-09-10
• Results posted: 2025-09-10

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study