NCT07236476

Identify Effective Doses of LY01021 in Controlled Ovarian Hyperstimulation (COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)

A Multicentre, Open-label, Dose-finding, Phase 2 Study to Investigate the Efficacy, and Safety of Different Doses of LY01021 in Controlled Ovarian Hyperstimulation(COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: Female
• Age: 20 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentre, open-label, dose-finding, phase 2 study that will recruit approximately 90 female subjects undergoing COH for in vitro fertilization (IVF) or intracytoplasmic single sperm injection (ICSI). Three LY01021 dose groups of 40 mg QD, 30 mg QD, and 20 mg QD will be included, with not exceed 45 subjects in each group to investigate the efficacy and safety.

Conditions

• Assisted Reproduction

Interventions

Type	Name	Description
DRUG	LY01021	LY01021 should be taken orally once a day.

Timeline

• Start date: 2024-10-09
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-11-19
• Last updated: 2025-11-19

Locations

1 site across 1 country: China