clinical trial · NCT07122401
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Shaanxi Micot Pharmaceutical Technology Co., Ltd.·phase3·recruiting·n = 424
Secondary Hyperparathyroidism, Chronic Kidney DiseaseMT1013Cinacalcet
brief summary
MT1013 is a first-in-class dual-target agonist. This study is a multicenter, randomized, double-blind, double-dummy phase III clinical study being conducetd to evaluate the efficacy and safety of MT1013 compared with active control cinacalcet in secondary hyperparathyroidism patients on maintenance dialysis. Subjects will be 1:1 randomized to receive MT1013 or cinacalcet for 26 weeks. Evaluations of iPTH, Ca, P, BMD, and biomarkers will be done across the study period, to compare efficacy and safety of MT1013 to cinacalcet.
started
Sep 30, 2025
primary completion
Nov 26, 2026
completion
Nov 26, 2026
last updated
Oct 1, 2025
official title
A Multicenter, Randomized, Double-blind, Double-dummy, Phase III Study to Evaluate the Efficacy and Safety of MT1013 Versus Cinacalcet as Active Control in Secondary Hyperparathyroidism Patients on Maintenance Dialysis
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol