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Evaluating VGA039 in Healthy Volunteers and Patients with Von Willebrand Disease

A Multi-Modular Trial to Evaluate VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease and Other Bleeding Disorders (VIVID)

Phase1; Phase2 Interventional Vega Therapeutics, Inc · NCT05776069

This study is testing a new treatment called VGA039 to see if it is safe and effective for healthy people and those with von Willebrand Disease.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment116 (estimated)
Ages12 Years to 60 Years
SexAll
SponsorVega Therapeutics, Inc Industry-sponsored
Locations25 sites (Los Angeles, California and 24 other locations)
Trial IDNCT05776069 on ClinicalTrials.gov

What this trial studies

The VIVID study is a multi-part clinical trial assessing the safety and efficacy of VGA039, administered both intravenously and subcutaneously, in healthy volunteers and patients with von Willebrand Disease (VWD). It includes a randomized, double-blind, placebo-controlled phase for healthy participants, followed by open-label phases for VWD patients. Participants will be monitored for 15 weeks for intravenous dosing and 8 weeks for subcutaneous dosing. The study aims to explore both single and multiple doses, as well as surgical prophylaxis applications of VGA039.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 12 to 60 with a diagnosis of symptomatic von Willebrand Disease.

Not a fit: Patients with known pro-thrombotic disorders or those who have recently used hormonal contraceptives may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with von Willebrand Disease, potentially improving their management of bleeding episodes.

How similar studies have performed: While this approach is novel in its specific application, similar studies have shown promise in evaluating treatments for bleeding disorders.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria (All Subjects)

* Subjects, 18 to 60 years of age, inclusive for Parts 1 and 2
* Subjects, 12 to 60 years of age, inclusive for Parts 3 and 5
* No clinically significant laboratory, ECG, or vital signs results.

Additional Key Inclusion Criteria (for Subjects in Part 1 Only) • Body mass index of 18-32 kg/m2

Additional Key Inclusion Criteria (for Subjects in Part 2 Only)

* Subjects with VWD who are symptomatic, defined as having a history of bleeding or bruising.
* Hemoglobin level ≥ 8 g/dL and platelet count ≥ 150 × 109/L at Screening.

Exclusion Key Criteria (All Subjects)

* Use of hormonal contraceptives within 56 days prior to administration of the study drug.
* Subjects with detection of FV Leiden or Prothrombin G20210A mutation, protein C or S deficiency, antithrombin deficiency, or antiphospholipid antibody syndrome at Screening.
* Subjects with other known pro-thrombotic disorders or abnormal findings in any prior laboratory thrombophilia evaluation.
* History of arterial or venous thrombosis, including superficial thrombophlebitis, or embolism.
* Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular disease, cerebrovascular disease, peripheral vascular disease, or metabolic dysfunction.

Additional Key Exclusion Criterion (Subjects in Part 1 Only)

• Baseline FVIII activity \> 150 IU/dL.

Additional Key Exclusion Criteria (Subjects in Parts 2, 3, 4 and 5 Only)

* Baseline FVIII activity \> 50 IU/dL.
* Any acute, clinically significant bleeding event requiring surgical or procedural intervention within 7 days prior to receiving study drug.

Where this trial is running

Los Angeles, California and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Von Willebrand DiseasesVon Willebrand DisorderVWDStar TherapeuticsVega TherapeuticsVIVIDVIVID-1VIVID-2
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.