NCT07122401

Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 424 (estimated)
• Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Secondary Hyperparathyroidism, Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	MT1013	MT1013 + dummy cinacalcet
DRUG	Cinacalcet	Cinacalcet + dummy MT1013

Timeline

• Start date: 2025-09-30
• Primary completion: 2026-11-26
• Completion: 2026-11-26
• First posted: 2025-08-14
• Last updated: 2025-10-01

Locations

1 site across 1 country: China