Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ZL-1109 (VRDN-003)
ZL-1109 · 1 trial · 1 indication
Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the study eye \[without a corresponding increase of ≥2 mm in the fellow eye\]
| Arm | Type | Description |
|---|---|---|
| Randomized controlled period: ZL-1109 every 4 weeks | EXPERIMENTAL | Participants will receive ZL-1109 per protocol defined dosing regimen. |
| Randomized controlled period: ZL-1109 every 8 weeks | EXPERIMENTAL | Participants will receive ZL-1109 and placebo per protocol defined dosing regimen. |
| Randomized controlled period: Placebo every 4 weeks | PLACEBO_COMPARATOR | Participants will receive placebo per protocol defined dosing regimen. |
| OLE treatment period: ZL-1109 every 4 weeks | OTHER | Participants who not responded would receive ZL-1109 per protocol defined dosing regimen. |
| Name | Type | Description |
|---|---|---|
| ZL-1109 (VRDN-003) | DRUG | ZL-1109 subcutaneous injection |
| Placebo | DRUG | Matching placebo subcutaneous injection |
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 Criteri...
ZL-1109 is being developed for the treatment of thyroid eye disease (TED), also known as Graves' orbitopathy. It is an investigational small molecule designed to target the IGF-1R pathway. ZL-1109 is currently in Phase 3 clinical development for active thyroid eye disease in Chinese participants.
ZL-1109 targets IGF-1R, the insulin-like growth factor 1 receptor. By binding to this receptor, ZL-1109 is designed to interfere with the signaling that contributes to inflammation and tissue expansion in thyroid eye disease. This mechanism is being evaluated in a Phase 3 trial for active TED.
ZL-1109 is being developed by Zai Lab Limited, a biopharmaceutical company traded on the Nasdaq under the ticker ZLAB. Zai Lab is conducting a Phase 3 clinical trial of ZL-1109 in Chinese participants with active thyroid eye disease.
ZL-1109 is in Phase 3 clinical development. The ongoing trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of ZL-1109 in Chinese participants with active thyroid eye disease. The trial is currently active but not recruiting.
ZL-1109 is being studied in one Phase 3 clinical trial, NCT07211776, titled "A Study to Assess the Efficacy and Safety of ZL-1109 in Chinese Participants With Active Thyroid Eye Disease." The trial has an enrollment of 108 participants, is randomized, double-blind, and placebo-controlled, and is being conducted in China.
Yes, ZL-1109 is also known as ZL-1109 (VRDN-003). The two names refer to the same investigational drug candidate. ZL-1109 is the name used by Zai Lab, which is developing it for thyroid eye disease.