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NCT06384547 · ClinicalTrials.gov registry record · Phase 3
A Randomized, Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED)
A Phase 3 study, sponsored by Viridian Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 231
- Enrollment target
NCT06384547: Completed Phase 3 study, sponsored by Viridian Therapeutics.
NCT06384547 is a Phase 3 study that has completed, run by Viridian Therapeutics. The registered enrollment target is 231 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06384547, a Phase 3 study, has completed, sponsored by Viridian Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 231 participants
- Enrollment target
Study Summary
The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease (TED). The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in patients with TED.
Primary Outcome
An adverse event (AE) was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAE was defined as an AE occurring on or after the day of the first dose of study medication through the end of the study. A summary of all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Interventions
- DRUG VRDN-001 10 mg/kg
- DRUG VRDN-001 3 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2024-05-23 |
| Est. Completion | 2026-01-19 |
| Phase | Phase 3 |
What the finished NCT06384547 record still lists
NCT06384547 is an interventional study that assigns participants to a tested intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which VRDN-001 10 mg/kg is the first listed.
NCT06384547 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06384547 about?
NCT06384547 is a clinical study titled "A Randomized, Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED)". The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye d...
What is the current status of trial NCT06384547?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 231 participants. The study started on 2024-05-23. Estimated completion is 2026-01-19.
What interventions are being tested in trial NCT06384547?
The interventions under investigation include: VRDN-001 10 mg/kg (DRUG), VRDN-001 3 mg/kg (DRUG).
Who is sponsoring clinical trial NCT06384547?
This trial is sponsored by Viridian Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06384547's enrollment target sits among peer trials
231 1300th of 2000 higher than 697 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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