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New hope for thyroid eye disease: phase 3 drug trial launches in china

NCT ID NCT07211776

Disease control Sponsor: Zai Lab (Shanghai) Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study tests a new drug called ZL-1109 for people with moderate to severe thyroid eye disease, a condition that causes eye bulging and discomfort. About 99 Chinese adults will receive either the drug or a placebo to see if it safely reduces eye bulging by at least 2 millimeters. The trial is double-blinded, meaning neither participants nor doctors know who gets the real treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

108 people

The number who actually took part.

Started

Dec 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Have moderate to severe TED 2. Must meet the clinical diagnosis criteria of active TED 3. Must agree to use highly effective contraception as specified in the protocol 4. Female TED participants must have a negative serum pregnancy test at screening Key Exclusion Criteria: 1. Have received prior treatment with another anti-IGF-1R mAb or anti-thyroid stimulating hormone receptor (TSHR) mAb. 2. 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. 3. Have corneal decompensation in the study eye unresponsive to medical management. 4. Have a pre-existing ophthalmic in the study eye which in the opinion of the Investigator, would confound interpretation of the study results.

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Conditions

The condition(s) this trial relates to.

endocrine exophthalmos Graves Ophthalmopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Thyroid eye disease, ted

Contacts and locations

Locations

  • Site01001

    Shanghai, China

  • Site01002

    Hefei, China

  • Site01004

    Fuzhou, China

  • Site01005

    Luoyang, China

  • Site01006

    Beijing, China

  • Site01007

    Guangzhou, China

  • Site01008

    Foshan, China

  • Site01009

    Beijing, China

  • Site01010

    Beijing, China

  • Site01011

    Dalian, China

  • Site01012

    Shenyang, China

  • Site01013

    Tianjin, China

  • Site01016

    Wuxi, China

  • Site01017

    Nanchang, China

  • Site01018

    Hangzhou, China

  • Site01019

    Zhengzhou, China

  • Site01020

    Changsha, China

  • Site01022

    Chengdu, China

  • Site01023

    Taiyuan, China

  • Site01024

    Jinan, China

  • Site01026

    Yangzhou, China

  • Site01027

    Guiyang, China

  • Site01028

    Xi'an, China

  • Site01029

    Bengbu, China

  • Site01030

    Zhengzhou, China

  • Site01031

    Chongqing, China

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