drugset / Trial / NCT07122401

Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism

NCT07122401

Phase 3 Recruiting 424 enrolled Shaanxi Micot Pharmaceutical Technology Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-09-30
Primary completion
2026-11-26
Completion
2026-11-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cinacalcet Other / unclassified Oral
Subject MT1013 Peptide Intravenous