drugset / Trial / NCT06804590

A Study on Efficacy, Safety and Immunogenicity of 9MW0311 in Postmenopausal Women With Osteoporosis

NCT06804590

Phase 3 Recruiting 278 enrolled Mabwell (Shanghai) Bioscience Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a multicenter, randomized, double-blinded, parallel-group Phase III clinical study to compare the clinical efficacy, safety, and immunogenicity of 9MW0311 and Prolia® in Chinese postmenopausal women with osteoporosis at high risk for fracture.

Timeline

Start
2024-11-16
Primary completion
2026-04-30
Completion
2026-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Denosumab Monoclonal antibody 60 mg Subcutaneous