Thyroid Eye Disease (TED)Phase 3NCT07211776
A Study to Assess the Efficacy and Safety of ZL-1109 in Chinese Participants With Active Thyroid Eye Disease
A Phase 3 study testing ZL-1109 (VRDN-003) in people with Thyroid Eye Disease (TED), run by Zai Lab (Shanghai) Co., Ltd. at 26 sites in China.
Trial summary
A Multicenter, Double-blinded, Randomized, Placebo-controlled Phase 3 Study of ZL-1109 in Chinese Participants with Thyroid Eye Disease (TED) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Eye Disease (TED)
- What is being tested?
- ZL-1109 (VRDN-003)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 26 sitesChina
- Study dates
- 5 Dec 2025to 29 Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites
Site01006
Beijing
Site01009
Beijing
Site01010
Beijing
Site01029
Bengbu
Site01020
Changsha
Site01022
Chengdu
Site01031
Chongqing
Site01011
Dalian
Site01008
Foshan
Site01004
Fuzhou
Site01007
Guangzhou
Site01027
Guiyang
Site01018
Hangzhou
Site01002
Hefei
Site01024
Jinan
Site01005
Luoyang
Site01017
Nanchang
Site01001
Shanghai
Site01012
Shenyang
Site01023
Taiyuan
Site01013
Tianjin
Site01016
Wuxi
Site01028
Xi'an
Site01026
Yangzhou
Site01019
Zhengzhou
Site01030
Zhengzhou
About this study
Official title: 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)
A Multicenter, Double-blinded, Randomized, Placebo-controlled Phase 3 Study of ZL-1109 in Chinese Participants with Thyroid Eye Disease (TED)
Read the 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)
- Being tested
- ZL-1109 (VRDN-003), Placebo
- Keywords
- Thyroid Eye Disease (TED)
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZL-1109 (VRDN-003)Drug
ZL-1109 subcutaneous injection
PlaceboDrug
Matching placebo subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Randomized controlled period: ZL-1109 every 4 weeks | Experimental | Participants will receive ZL-1109 per protocol defined dosing regimen. Receives: Drug: ZL-1109 (VRDN-003) |
| Randomized controlled period: ZL-1109 every 8 weeks | Experimental | Participants will receive ZL-1109 and placebo per protocol defined dosing regimen. Receives: Drug: ZL-1109 (VRDN-003); Drug: Placebo |
| Randomized controlled period: Placebo every 4 weeks | Placebo comparator | Participants will receive placebo per protocol defined dosing regimen. Receives: Drug: Placebo |
| OLE treatment period: ZL-1109 every 4 weeks | Other | Participants who not responded would receive ZL-1109 per protocol defined dosing regimen. Receives: Drug: ZL-1109 (VRDN-003) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: At Week 24
Secondary outcomes (7)
Change from baseline in proptosis in the study eye
Change from baseline in proptosis in the study eye
Measured: At Week 24
Overall 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]) AND ≥ 2 points reduction in CAS from baseline in the study eye [without a corresponding increase of ≥2 points in the fellow eye]
Measured: At Week 24
Change from baseline in Clinical Activity Score (CAS) in the study eye
Change from baseline in CAS in the study eye [range, 0 to 7, with higher scores indicating greater level of inflammation]
Measured: At Week 24
Proportion of participants with a Clinical Activity Score (CAS) of 0 or 1 in the study eye
Proportion of participants with a CAS of 0 or 1 in the study eye
Measured: At Week 24
Diplopia Responder Rate for participants with baseline Diplopia Score greater than 0
Proportion of participants with a reduction in Diplopia Score of ≥1 from baseline (for participants with baseline Diplopia Score greater than 0)
Measured: At Week 24
Diplopia Resolution Rate for participants with baseline Diplopia Score greater than 0
Proportion of participants with a reduction in Diplopia Score to 0 from baseline (for participants with baseline Diplopia Score greater than 0)
Measured: At Week 24
Clinical Activity Responder Rate in the study eye
Clinical Activity Responder Rate in the study eye (i.e., ≥ 2 points reduction in CAS from baseline in the study eye [without a corresponding increase of ≥2 points in the fellow eye])
Measured: At Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start5 Dec 2025
- Primary completion14 Mar 2027 (estimated)
- Study completion29 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye Disease (TED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of the three study arms.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211776
- Sponsor's protocol ID
- ZL-1109-002
- Status last verified
- Sep 2026
- First submitted
- 1 Oct 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07211776
- Acronym / sponsor ID
- ZL-1109-002
- Conditions
- Thyroid Eye Disease (TED)
- Keywords
- Thyroid Eye Disease (TED)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 14 Mar 2027 (estimated)
- Study completion
- 29 Jan 2028 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomized to one of the three study arms.
| Arm | Type | Receives |
|---|---|---|
| Randomized controlled period: ZL-1109 every 4 weeks | Experimental | Drug: ZL-1109 (VRDN-003)Participants will receive ZL-1109 per protocol defined dosing regimen. |
| Randomized controlled period: ZL-1109 every 8 weeks | Experimental | Drug: ZL-1109 (VRDN-003), Drug: PlaceboParticipants will receive ZL-1109 and placebo per protocol defined dosing regimen. |
| Randomized controlled period: Placebo every 4 weeks | Placebo comparator | Drug: PlaceboParticipants will receive placebo per protocol defined dosing regimen. |
| OLE treatment period: ZL-1109 every 4 weeks | Other | Drug: ZL-1109 (VRDN-003)Participants who not responded would receive ZL-1109 per protocol defined dosing regimen. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZL-1109 (VRDN-003)ZL-1109 subcutaneous injection | Drug | OLE treatment period: ZL-1109 every 4 weeks, Randomized controlled period: ZL-1109 every 4 weeks, Randomized controlled period: ZL-1109 every 8 weeks |
| PlaceboMatching placebo subcutaneous injection | Drug | Randomized controlled period: Placebo every 4 weeks, Randomized controlled period: ZL-1109 every 8 weeks |
Primary outcome
Proptosis Responder Rate in the study eye
Time frame: At Week 24
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]
7 secondary outcomes
Change from baseline in proptosis in the study eye
Time frame: At Week 24
Overall Responder Rate in the study eye
Time frame: At Week 24
Change from baseline in Clinical Activity Score (CAS) in the study eye
Time frame: At Week 24
Proportion of participants with a Clinical Activity Score (CAS) of 0 or 1 in the study eye
Time frame: At Week 24
Diplopia Responder Rate for participants with baseline Diplopia Score greater than 0
Time frame: At Week 24
Diplopia Resolution Rate for participants with baseline Diplopia Score greater than 0
Time frame: At Week 24
Clinical Activity Responder Rate in the study eye
Time frame: At Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ZL-1109 (VRDN-003) in people with Thyroid Eye Disease (TED), run by Zai Lab (Shanghai) Co., Ltd. at 26 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proptosis Responder Rate in the study eye (time frame: At Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.