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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
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.
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.
Age
50 - 85 years
Sex
FEMALE
Healthy Volunteers
No
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Start Date
June 30, 2019
Primary Completion Date
September 30, 2021
Completion Date
December 31, 2021
Last Updated
September 29, 2021
448
ESTIMATED participants
LY06006
DRUG
Lead Sponsor
Luye Pharma Group Ltd.
Collaborators
NCT05010590
NCT07329543
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05060380