Abstract: TH-PO1199
Efficacy and Safety of MT1013 vs. Etelcalcetide for Secondary Hyperparathyroidism in Patients on Hemodialysis
Session Information
- Late-Breaking Research Posters
November 06, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Bone and Mineral Metabolism
- 502 Bone and Mineral Metabolism: Clinical
Authors
- Wang, Linyuan, Shaanxi Micot Pharmaceutical Technology Co., Ltd, Xi'an, Shanxi Province, China
- Zhang, Ping, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
- Chen, Jianghua, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
- Wang, Xiangling, Shaanxi Micot Pharmaceutical Technology Co., Ltd, Xi'an, Shanxi Province, China
- Yu, Zhi, Shaanxi Micot Pharmaceutical Technology Co., Ltd, Xi'an, Shanxi Province, China
- Huang, Zhian, Shaanxi Micot Pharmaceutical Technology Co., Ltd, Xi'an, Shanxi Province, China
Background
MT1013, developed by Shaanxi Micot Pharmaceutical Technology Co., Ltd., is a first-in-class dual agonist targeting both the calcium-sensing receptor (CaSR) and osteogenic growth peptide (OGP). It is indicated for the treatment of SHPT in patients undergoing maintenance dialysis. In addition to its action on CaSR, MT1013 engages OGP—a target that promotes mesenchymal stem cell differentiation into osteoblasts and enhances bone formation. This dual mechanism further assists in regulating levels of iPTH, calcium, and phosphorus.
Methods
A head-to-head Phase II trial (NCT06690242) was conducted to compare two dose titration regimens of MT1013 with etelcalcetide and placebo, with 114 patients enrolled. All study drugs were administered intravenously three times per week. Efficacy and safety were assessed after 26 weeks of continuous treatment.
Results
After 26-week treatment, both MT1013 groups demonstrated efficacy comparable to etelcalcetide in achieving >30% or >50% reductions in iPTH levels. Specifically, >30% reduction rates were 83.9% (Group 1), 93.3% (Group 2), and 90.6% (etelcalcetide); >50% reduction rates were 74.2%, 76.7%, and 78.1%, respectively. After 26 weeks of treatment, the target achievement rates for iPTH (2–9×ULN), calcium (2.1–2.5 mmol/L), and phosphorus (1.13–1.78 mmol/L), both individually and compositely, were higher in the MT1013 groups than in the etelcalcetide group. The composite target achievement rate was 30.3% in MT1013 Group 1, 31.25% in MT1013 Group 2, and 12.12% in the etelcalcetide group. A trend toward superiority of MT1013 was also observed in the magnitude of FGF-23 reduction, with decreases of 34.87% and 38.26% in the two MT1013 groups, compared to 21.31% in the etelcalcetide group. Similarly, a higher proportion of subjects achieved a >30% reduction in FGF-23 in the MT1013 groups (60% and 66.67%) than in the etelcalcetide group (48%). These results suggest MT1013 may reduce cardiovascular risk and improve prognosis. It was well tolerated in CKD-SHPT patients, with no severe TEAEs, drug-related SAEs, or new safety signals.
Conclusion
MT1013 outperforms etelcalcetide with higher on-target rates for iPTH, Ca, and P. Its dual-targeting mechanism provides holistic control of mineral metabolism and FGF-23, offering potential for improved patient prognosis.
Funding
- Commercial Support – Shaanxi Micot Pharmaceutical Technology Co., Ltd