NCT05776069 · Vega Therapeutics, Inc
Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)
What this study is about
The VIVID study is structured in a master protocol format comprised of multiple parts that evaluate given through a vein (IV) (IV) and injected under the skin (SC) VGA039 in healthy volunteers and subjects with von Willebrand Disease (VWD) and other bleeding disorders.
View original scientific description
The VIVID study is structured in a master protocol format comprised of multiple parts that evaluate intravenous (IV) and subcutaneous (SC) VGA039 in healthy volunteers and subjects with von Willebrand Disease (VWD) and other bleeding disorders.
Interventions
DRUG
VGA039
Single doses of VGA039
OTHER
Placebo
Single doses of Placebo
DRUG
VGA039
Multiple doses of VGA039
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]
Time frame: From start of study drug administration until 15 or 8 weeks after IV or SC study drug administration, respectively
Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs), including dose-limiting toxicities (DLTs).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 criteria
- 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. *
Where
- Los Angeles, California
- Sacramento, California
- Aurora, Colorado
- Atlanta, Georgia
- Morrisville, North Carolina
- Pittsburgh, Pennsylvania
- Nashville, Tennessee
- Dallas, Texas
- Seattle, Washington
- Milwaukee, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 26, 2025 · Source of record for eligibility and locations