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Phase 3Status unknownAge-related condition

Comparative Efficacy, Safety, PK, and Immunogenicity Study

A Randomized, Double-blind, Parallel-group, Active-controlled Comparative Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of LY06006 Compared With EU-Prolia in Postmenopausal Women With Osteoporosis

Sponsor
Luye Pharma Group Ltd. (Industry)
Enrolment
392 planned
Conditions
Osteoporosis, Postmenopausal
Interventions
Denosumab
Ages
adults, older adults
Registry
NCT05853354, EUCTR2022-002312-23

Full record on ClinicalTrials.gov

From the registry

this comparative clinical study is designed to demonstrate that LY06006 and EU-Prolia have no clinically meaningful differences in clinical efficacy, pharmacodynamic (PD), safety, PK, and immunogenicity in postmenopausal women with osteoporosis.

Primary outcomes

  • To demonstrate equivalent efficacy between LY06006 and EU-Prolia, in terms of BMD in female participants with postmenopausal osteoporosis;
  • EU Marketing Authorization only: To demonstrate similar PD between LY06006 and EU-Prolia, in terms of the bone resorption marker sCTX in female participants with postmenopausal osteoporosis

History

  1. Study completion

  2. Primary completion

  3. Last registry update

  4. Registered

  5. Started