Efficacy and Safety of JMT103 in the Treatment of Postmenopausal Women With Osteoporosis

Summary

This study is to evaluate the efficacy and safety of JMT103 in the treatment of postmenopausal women with osteoporosis.

Timeline

Start

2022-04-21

Primary completion

2023-12-31

Completion

2024-03-31

Outcome

Met primary endpoint

paper narlumosbart demonstrated superiority over placebo in increasing BMD at 12 months following administration at 6-month intervals PMID 40686685 ↗

paper all showed significant increases compared with the placebo group PMID 40686685 ↗

paper with LS mean differences (99% confidence interval [CI]) of 4.20% (1.92∼6.48), 5.90% (3.63∼8.16), and 5.11% (2.84∼7.39), respectively (all P < 0.001) PMID 40686685 ↗

Publications

• Chi Y, Li Y, Cheng Q, Cai H, Zeng Y, Sheng H, Song B, Li H, Shen L, Li M, Xing Y, Cheng M, Ma Y, Wang D, Zhu M, Lu W, Yan S, Zhang X, Yuan J, Yang B, Li J, Wang J, Wu Z, Xia W. Efficacy and safety of narlumosbart, an anti-RANKL monoclonal antibody, in postmenopausal women with osteoporosis: a multi-center, randomized, double-blind, placebo- and active-controlled, phased II study. EClinicalMedicine. 2025 Jul 4;85:103329. doi: 10.1016/j.eclinm.2025.103329. eCollection 2025 Jul.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Denosumab	Monoclonal antibody	60 mg	Subcutaneous
Subject	JMT103	Monoclonal antibody	45 mg	Subcutaneous
Subject	JMT103	Monoclonal antibody	60 mg	Subcutaneous
Subject	JMT103	Monoclonal antibody	90 mg	Subcutaneous

Indications