RecruitingPhase 3NCT07122401

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

Sponsor

Shaanxi Micot Pharmaceutical Technology Co., Ltd.

Enrollment

424 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

Secondary Hyperparathyroidism, Chronic Kidney Disease

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called MT1013 for treating secondary hyperparathyroidism — a condition where the parathyroid glands become overactive, commonly seen in people with kidney failure who are on dialysis. **You may be eligible if...** - You are 18 years or older with a BMI between 18 and 35 - You are on regular dialysis (3 times per week for at least 12 weeks) - Your parathyroid hormone (PTH) levels are elevated above a certain threshold - Your blood calcium levels are within an acceptable range **You may NOT be eligible if...** - You have had parathyroid surgery or radiation to the neck - You have recently started or changed dialysis settings significantly - You have active serious infections, cancer, or other serious medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMT1013

MT1013 + dummy cinacalcet

DRUGCinacalcet

Cinacalcet + dummy MT1013

Locations(1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

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NCT07122401