Recruiting
Phase 1
Phase 2

VGA039

Sponsor:

Vega Therapeutics, Inc

Code:

NCT05776069

Conditions

Von Willebrand Diseases

Eligibility Criteria

Sex: All

Age: 12 - 60

Healthy Volunteers: Accepted

Interventions

VGA039

Placebo

VGA039

Study Details

Brief summary:

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.

Conditions

Von Willebrand Diseases

Study ID

NCT05776069

Start date

Mar 16, 2023

Status verified date

Aug, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 60

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

116 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Part 1

Cohorts 1-8 IV or SC VGA039 or Placebo dose to be determined

experimental: Part 2

Cohorts A-H IV or SC VGA039 dose to be determined

experimental: Part 3

Cohorts MD-1 to MD-4, SC VGA039 multiple doses, dose to be determined

experimental: Part 4

Cohorts of VGA039 single dose for surgical prophylaxis

experimental: Part 5

Multiple doses of VGA039 in open label extension

Interventions

VGA039

Single doses of VGA039

Placebo

Single doses of Placebo

VGA039

Multiple doses of VGA039

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Clinical Trials

650-466-8041medinfo@star-therapeutics.com

Locations

Orthopedic Institute for Children (UCLA)

Recruiting

Los Angeles, California, United States, 90007

UC Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

University of Colorado School of Medicine

Recruiting

Aurora, Colorado, United States, 80045

Hemophilia of Georgia Center for Bleeding & Clotting Disorders of Emory

Recruiting

Atlanta, Georgia, United States, 30308

Science 37, Inc.

Recruiting

Morrisville, North Carolina, United States, 27560

Contacts

Science 37 Recruitment Team

984-377-3737recruitment@science37.com

Hemophilia Center of Western PA

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75235

Washington Center for Bleeding Disorders

Recruiting

Seattle, Washington, United States, 98101

Versiti Comprehensive Center for Bleeding Disorders

Recruiting

Milwaukee, Wisconsin, United States, 53233

Hamilton Health Sciences Corporation

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Queens University

Recruiting

Kingston, Ontario, Canada, K7L 3N6

St. Michaels Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

More Information

Sponsor

Vega Therapeutics, Inc

Last update posted

Aug 26, 2025

Last verified

Aug, 2025

Keywords

  • Von Willebrand Disorder
  • VWD
  • Star Therapeutics
  • Vega Therapeutics
  • VIVID
  • VIVID-1
  • VIVID-2
  • VIVID-3
  • VIVID-5
  • Bleeding disorders
  • VGA039
  • Blood coagulation disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Vega Therapeutics, Inc on 2025-08-26.