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Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism

NCT07122401 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2025-10-01

No results posted yet for this study

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

DRUG

MT1013

MT1013 + dummy cinacalcet

DRUG

Cinacalcet

Cinacalcet + dummy MT1013

Sponsors & Collaborators

  • Shaanxi Micot Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07122401 on ClinicalTrials.gov