NCT07211776

A Study to Assess the Efficacy and Safety of ZL-1109 in Chinese Participants With Active Thyroid Eye Disease

A Multicenter, Double-blinded, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ZL-1109 in Chinese Participants With Thyroid Eye Disease (TED)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Zai Lab (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Multicenter, Double-blinded, Randomized, Placebo-controlled Phase 3 Study of ZL-1109 in Chinese Participants with Thyroid Eye Disease (TED)

Detailed description

This is a multicenter, Phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety and tolerability of ZL-1109 in participants with active TED. The study will comprise a screening period of up to 28 days, a double-blinded randomized placebo-controlled period of 24 weeks and an extension period. For responders and non-responders who do not want to receive open-label treatment, the study period is 52 weeks from the first dose. For non-responders who consent to and are considered eligible to receive open-label treatment, the study period is 70 weeks from the first dose.

Conditions

• Thyroid Eye Disease (TED)

Interventions

Type	Name	Description
DRUG	ZL-1109 (VRDN-003)	ZL-1109 subcutaneous injection
DRUG	Placebo	Matching placebo subcutaneous injection

Timeline

• Start date: 2025-12-05
• Primary completion: 2027-03-14
• Completion: 2028-01-29
• First posted: 2025-10-08
• Last updated: 2025-12-29

Locations

27 sites across 1 country: China

Regulatory

• FDA-regulated drug study