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

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.

Start Date30 Sep 2025

Sponsor / Collaborator

Shaanxi Micot Technology Co., Ltd.

NCT06690242

/ RecruitingPhase 2

A Multicenter, Randomized,Positive Controlled, and Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of MT1013 Injection in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Undergoing Maintenance Hemodialysis

This is a randomized, positive controlled, and placebo-controlled phase II clinical study to evaluate the efficacy and safety of MT1013 injection in the treatment of chronic kidney disease with secondary hyperparathyroidism (SHPT) undergoing maintenance hemodialysis (MHD) subjects.

Start Date18 Nov 2024

Sponsor / Collaborator

Shaanxi Micot Technology Co., Ltd.

NCT06976177

/ RecruitingPhase 2

A Multi-center, Open, Single-arm Phase IIb Clinical Study to Evaluate the Safety and Efficacy of MT1013 Injection for the Treatment of Secondary Hyperparathyroidism (SHPT) Patients With Chronic Kidney Disease Undergoing Maintenance Dialysis

This is a multi-center, open, single-arm phase IIb clinical study comprising 2 parts, which Part A will enroll about 110 subjects, and Part B will enroll about 190 subjects to investigate long-term efficacy and safety of MT1013 after treatment.The treatment duration for Part A MAD study is 52 weeks and the duration for Part B study is 26 weeks.

Start Date07 Jun 2024

Sponsor / Collaborator

Shaanxi Micot Technology Co., Ltd.

100 Clinical Results associated with MT-1013

100 Translational Medicine associated with MT-1013

100 Patents (Medical) associated with MT-1013

100 Deals associated with MT-1013

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Kidney Diseases	Phase 3	China	Shaanxi Micot Technology Co., Ltd.	30 Sep 2025
Hyperparathyroidism, Secondary	Phase 3	China	Shaanxi Micot Technology Co., Ltd.	07 Aug 2025
Hypercalcemia	Phase 2	United States	Shaanxi Micot Technology Co., Ltd.	-
Hypercalcemia	Phase 2	China	Shaanxi Micot Technology Co., Ltd.	-

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