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

NCT07211776 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2025-12-29

No results posted yet for this study

Summary

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

Conditions

  • Thyroid Eye Disease (TED)

Interventions

DRUG

ZL-1109 (VRDN-003)

ZL-1109 subcutaneous injection

DRUG

Placebo

Matching placebo subcutaneous injection

Sponsors & Collaborators

  • Zai Lab (Shanghai) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-05
Primary Completion
2027-03-14
Completion
2028-01-29
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07211776 on ClinicalTrials.gov