Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07122401

Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism

Led by Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Updated on 2025-10-01

424

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to understand written information, willing to participate, and provide written informed consent
  • Male or female, at least 18 years old, with a body mass index (BMI) between 18 and 35 kg/m²
  • Receiving regular maintenance dialysis three times a week for at least 12 weeks before screening
  • Dialysate calcium concentration of at least 1.25 mmol/L (2.5 mEq/L)
  • Confirmed diagnosis of secondary hyperparathyroidism with mean pre-dialysis intact parathyroid hormone (iPTH) level of 400 pg/mL or higher based on two measurements before dialysis within 14 days prior to randomization
  • Serum calcium levels of 8.4 mg/dL (2.1 mmol/L) or higher on two non-consecutive pre-dialysis measurements within 14 days prior to randomization
Not Eligible

You will not qualify if you...

  • Parathyroidectomy within 6 months before screening or planned parathyroidectomy, ablation, or radiation during the study
  • History of gastrointestinal bleeding or peptic ulcer within 6 months before screening
  • New York Heart Association Class III or IV heart failure within 3 months before screening, symptomatic arrhythmia within 6 months, or history of torsades de pointes
  • QTcF interval over 470 ms in males or over 480 ms in females on screening ECG, or other significant ECG abnormalities
  • Severe uncontrolled hypertension during screening, defined as systolic blood pressure over 180 mmHg and/or diastolic blood pressure over 110 mmHg despite optimal medical therapy
  • History of seizure within 1 year before screening or currently treated for seizure disorders
  • Use of oral cinacalcet or ivocalcet within 14 days before screening, or Etelcalcetide injection within 4 months before screening
  • Any other condition that makes participation unsuitable according to the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Zhongshan Hospital

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

X

Xiaoqiang Ding, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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