NCT05060406

A Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 448 (estimated)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: Female
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, randomized, double-blind, placebo-controlled phase III clinical study will be conducted to evaluate the efficacy and safety of LY06006 in the treatment of postmenopausal women with osteoporosis at high risk for fracture, as well as an exploratory population pharmacokinetic analysis of LY06006.

Detailed description

It is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. Primary Objective: To evaluate the efficacy of LY06006 in the treatment of postmenopausal women with osteoporosis at high risk for fracture. Secondary Objectives: To evaluate the safety of LY06006. To evaluate the immunogenicity of LY06006. Population pharmacokinetic analysis of LY06006.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	LY06006	60 mg/1 ml, once every 6 months administered subcutaneously, two injections in total

Timeline

• Start date: 2019-06-30
• Primary completion: 2021-09-30
• Completion: 2021-12-31
• First posted: 2021-09-29
• Last updated: 2021-09-29

Locations

1 site across 1 country: China