Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07211776 | A Study to Assess the Efficacy and Safety of ZL-1109 in Chinese Participants With Active Thyroid Eye Disease | PHASE3 | RECRUITING | 99 | — | — | Dec 5, 2025 | Jan 29, 2028 | Dec 29, 2025 | 27 | China |
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...