Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism

NCT07122401 | Recruiting Phase 3

• 1 other identifier: MT1013-III-C01
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Percentage of participants with > 50% reduction from baseline in mean intact parathyroid (iPTH)

  EAP（Week 22-27）

• Percentage of participants with > 30% reduction from baseline in mean iPTH

  EAP（Week 22-27）

Secondary Outcomes (4)

• Change From Baseline in Bone Mineral Density

  Week 27

• Change from baseline in serum calcium

  EAP（Week 22-27）

• Change From Baseline in serum phosphorus

  EAP（Week 22-27）

• Safety and Tolerance

  Up to Week 30

Study Arms (2)

MT1013

EXPERIMENTAL

MT1013 is administered intravenously (IV) for 26 weeks; Dummy cinacalcet will be administered orally for 26 weeks.

Drug: MT1013

Cinacalcet

ACTIVE COMPARATOR

Cinacalcet is administered orally for 26 weeks. Dummy MT1013 is administered intravenously (IV) for 26 weeks.

Drug: Cinacalcet

Interventions

MT1013 DRUG

MT1013 + dummy cinacalcet

MT1013

Cinacalcet DRUG

Cinacalcet + dummy MT1013

Cinacalcet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants capable of understanding written information ,willing to participate in, and provide a written informed consent;
• Male or female, at least 18 years old, 18 kg/m\^2 ≤BMI≤35 kg/m\^2;
• Receiving regular maintenance dialysis 3 times a week for at least 12 weeks prior to screening；
• Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L);
• Subjects must have a confirmed diagnosis of Secondary Hyperparathyroidism (SHPT), with a mean pre-dialysis serum intact parathyroid hormone (iPTH) level ≥ 400 pg/mL (42.4 pmol/L), based on measurements from two non-consecutive days before dialysis, within 14 days prior to randomization;
• Within 14 days prior to randomization, subjects must have serum calcium levels (measured pre-dialysis, or corrected serum calcium if albumin \<40 g/L) ≥ 8.4 mg/dL (2.1 mmol/L) on two non-consecutive pre-dialysis measurements.

You may not qualify if:

• Underwent parathyroidectomy within 6 months prior to screening, or anticipated parathyroidectomy, ablation or radiation during the study;
• Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
• New York Heart Association (NYHA) Class III or IV heart failure within 3 months prior to screening; Symptomatic arrhythmia within 6 months prior to screening; History of torsades de pointes (TdP).
• QTcF interval \>470 ms in males or \>480 ms in females on screening ECG, or other clinically significant ECG abnormalities as determined by the Investigator (e.g., third-degree atrioventricular block, sick sinus syndrome, multifocal frequent ventricular premature contractions, ventricular tachycardia, atrial fibrillation, etc.).
• Subjects with severe uncontrolled hypertension during the screening period are excluded, defined as systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>110 mmHg despite optimal medical therapy prior to enrollment (excluding transient blood pressure abnormalities during dialysis).
• History of seizure within 1 year prior to screening, or currently receiving treatment for seizure disorders;
• Received oral cinacalcet or ivocalcet within 14 days prior to screening, or received Etelcalcetide injection treatment within 4 months prior to screening;
• Any other condition that, in the Investigator's judgment, would make the subject unsuitable for participation in this study.

Sponsors & Collaborators

• Shaanxi Micot Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Renal Insufficiency, Chronic

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Central Study Contacts

Xiaoqiang Ding, MD

CONTACT

021-31587862; DING.XIAOQIANG@ZS-HOSPITAL.SH.CN

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 14, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): November 26, 2026
• Study Completion (Estimated): November 26, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

CN (1)