Clinical Trial

Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism

Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-12.
Status change: Not Yet Recruiting → Recruiting 2025-09-30
Trial Details
NCT Number NCT07122401
Lead Sponsor Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Conditions Secondary Hyperparathyroidism, Chronic Kidney Disease
Enrollment 424 participants
Start Date 2025-09-30
Primary Completion 2026-11-26 (estimated)
Study Completion 2026-11-26 (estimated)
Updated on ClinicalTrials.gov 2025-10-01