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NCT Number: 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 Study of ZL-1109 in Chinese Participants with Thyroid Eye Disease (TED)

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Key information

Conditions

Thyroid Eye Disease (TED) Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Graves Ophthalmopathy Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site01006, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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:

  • 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.

Treatment and study plan

ZL-1109 (VRDN-003)

Drug

ZL-1109 subcutaneous injection

Placebo

Drug

Matching placebo subcutaneous injection

Primary outcomes

  1. 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]

Secondary outcomes

  1. Change from baseline in proptosis in the study eye

    Time frame: At Week 24

    Change from baseline in proptosis in the study eye

  2. Overall 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]) AND ≥ 2 points reduction in CAS from baseline in the study eye [without a corresponding increase of ≥2 points in the fellow eye]

  3. Change from baseline in Clinical Activity Score (CAS) in the study eye

    Time frame: At Week 24

    Change from baseline in CAS in the study eye [range, 0 to 7, with higher scores indicating greater level of inflammation]

  4. Proportion of participants with a Clinical Activity Score (CAS) of 0 or 1 in the study eye

    Time frame: At Week 24

    Proportion of participants with a CAS of 0 or 1 in the study eye

  5. Diplopia Responder Rate for participants with baseline Diplopia Score greater than 0

    Time frame: At Week 24

    Proportion of participants with a reduction in Diplopia Score of ≥1 from baseline (for participants with baseline Diplopia Score greater than 0)

  6. Diplopia Resolution Rate for participants with baseline Diplopia Score greater than 0

    Time frame: At Week 24

    Proportion of participants with a reduction in Diplopia Score to 0 from baseline (for participants with baseline Diplopia Score greater than 0)

  7. Clinical Activity Responder Rate in the study eye

    Time frame: At Week 24

    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])

Study contacts

Contact information is provided by the study sponsor or research team.

ZL-1109-002 Study Team

CONTACT

[email protected]

86 021-61632588

Sponsors and collaborators

Lead sponsor

Zai Lab (Shanghai) Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 8, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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