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)
1 other identifier
interventional
108
1 country
26
Brief Summary
A Multicenter, Double-blinded, Randomized, Placebo-controlled Phase 3 Study of ZL-1109 in Chinese Participants with Thyroid Eye Disease (TED)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2025
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2025
CompletedFirst Posted
Study publicly available on registry
October 8, 2025
CompletedStudy Start
First participant enrolled
December 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 29, 2028
September 9, 2026
September 1, 2026
1.3 years
October 1, 2025
September 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proptosis Responder Rate in the study eye
Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the study eye \[without a corresponding increase of ≥2 mm in the fellow eye\]
At Week 24
Secondary Outcomes (7)
Change from baseline in proptosis in the study eye
At Week 24
Overall Responder Rate in the study eye
At Week 24
Change from baseline in Clinical Activity Score (CAS) in the study eye
At Week 24
Proportion of participants with a Clinical Activity Score (CAS) of 0 or 1 in the study eye
At Week 24
Diplopia Responder Rate for participants with baseline Diplopia Score greater than 0
At Week 24
- +2 more secondary outcomes
Study Arms (4)
Randomized controlled period: ZL-1109 every 4 weeks
EXPERIMENTALParticipants will receive ZL-1109 per protocol defined dosing regimen.
Randomized controlled period: ZL-1109 every 8 weeks
EXPERIMENTALParticipants will receive ZL-1109 and placebo per protocol defined dosing regimen.
Randomized controlled period: Placebo every 4 weeks
PLACEBO COMPARATORParticipants will receive placebo per protocol defined dosing regimen.
OLE treatment period: ZL-1109 every 4 weeks
OTHERParticipants who not responded would receive ZL-1109 per protocol defined dosing regimen.
Interventions
ZL-1109 subcutaneous injection
Matching placebo subcutaneous injection
Eligibility Criteria
You may qualify if:
- Have moderate to severe TED
- Must meet the clinical diagnosis criteria of active TED
- Must agree to use highly effective contraception as specified in the protocol
- Female TED participants must have a negative serum pregnancy test at screening
You may not qualify if:
- Have received prior treatment with another anti-IGF-1R mAb or anti-thyroid stimulating hormone receptor (TSHR) mAb.
- Have received systemic corticosteroids or steroid eye drops for any condition, or other immunosuppressive drugs for any condition, including TED, or radioactive iodine (RAI) treatment within a certain period prior to first dose.
- Have corneal decompensation in the study eye unresponsive to medical management.
- Have a pre-existing ophthalmic in the study eye which in the opinion of the Investigator, would confound interpretation of the study results.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Site01006
Beijing, China
Site01009
Beijing, China
Site01010
Beijing, China
Site01029
Bengbu, China
Site01020
Changsha, China
Site01022
Chengdu, China
Site01031
Chongqing, China
Site01011
Dalian, China
Site01008
Foshan, China
Site01004
Fuzhou, China
Site01007
Guangzhou, China
Site01027
Guiyang, China
Site01018
Hangzhou, China
Site01002
Hefei, China
Site01024
Jinan, China
Site01005
Luoyang, China
Site01017
Nanchang, China
Site01001
Shanghai, China
Site01012
Shenyang, China
Site01023
Taiyuan, China
Site01013
Tianjin, China
Site01016
Wuxi, China
Site01028
Xi'an, China
Site01026
Yangzhou, China
Site01019
Zhengzhou, China
Site01030
Zhengzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants, Investigator, Outcomes Assessor and Sponsor will be masked.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2025
First Posted
October 8, 2025
Study Start
December 5, 2025
Primary Completion (Estimated)
March 14, 2027
Study Completion (Estimated)
January 29, 2028
Last Updated
September 9, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share
The study team does not plan to make individual participant data underlying the published results publicly available. This decision is based on two key considerations: (1) the absence of informed consent at the participant level for reuse of data beyond the pre-specified analyses outlined in the study protocol; (2) applicable privacy regulations in relevant jurisdictions which restrict the further dissemination of personally identifiable information. Aggregate-level data supporting the primary findings of the study will be made available through supplementary materials accompanying the publication, and may also be shared upon reasonable request to the corresponding author for purposes such as meta-analysis or regulatory review, provided that a formal data use agreement is executed.