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A Safety, Tolerability and Efficacy Study of Veligrotug (VRDN 001) in Healthy Volunteers and Participants With Thyroid Eye Disease (TED) ( THRIVE )

NCT05176639 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2025-07-18

No results posted yet for this study

Summary

The investigational drug, veligrotug (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 establish the safety, tolerability, and efficacy of veligrotug, and the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of veligrotug in active TED patients who received 10 mg/kg.

Conditions

  • Thyroid Eye Disease

Interventions

DRUG

VRDN-001 Phase 3 Cohort (THRIVE)

5 IV Infusions of veligrotug (VRDN-001) 10mg/kg

DRUG

VRDN-001 Placebo

5 IV Infusions of veligrotug (VRDN-001) placebo

Sponsors & Collaborators

  • Viridian Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-03
Primary Completion
2024-07-15
Completion
2025-03-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05176639 on ClinicalTrials.gov