Semaglutide Delivered Epi-Intradermally by Microarray Patch (VX-201) Versus Subcutaneous Administration in Healthy Overweight and Obese Participants

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Terrestrial Bio, Inc.
Study ID
NCT07673900
Phase
PHASE1
Status
Recruiting
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Conditions

  • Overweight and/or Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • VX-201 — COMBINATION_PRODUCT
    VX-201 is a needle free, shelf-stable, microneedle array patch (MAP) for delivery of semaglutide epi/intra-dermally
  • semaglutide SC — DRUG
    Semaglutide is a long acting GLP-1 analogue with low renal clearance and an elimination half-life of approximately 7 days following subcutaneous administration.

Study Details

VX-201-101 is a first-in-human Phase 1 clinical study evaluating VX-201, a needle-free microneedle (MN) array patch (MAP) that delivers semaglutide through the skin as an alternative to subcutaneous (SC) injection.

Key Dates

Start date
Jun 15, 2026
Status verified
Jun 2026
Primary completion
Feb 10, 2027
Completion
May 18, 2027

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VX-201 0.25 mg SAD Phase
    Subjects will receive a single 0.25 mg VX-201 dose
  • Active Comparator: Single 0.25 mg semaglutide SC dose
    Subjects will receive a single 0.25 mg semaglutide SC dose
  • Experimental: Multiple VX-201 1.7 and 2.5 mg dose
    Subjects will receive four weekly 1.7 mg VX-201 doses followed by four weekly 2.4 mg VX-201 doses
  • Active Comparator: Multiple semaglutide SC 1.7 and 2.5 mg dose
    Subjects will receive four weekly 1.7 mg of semaglutide SC doses followed by four weekly 2.4 mg semaglutide SC doses
  • Experimental: Single VX-201 0.5 mg dose
    Subjects will receive a single 0.5 mg VX-201 dose
  • Active Comparator: Single semaglutide SC 0.5 mg dose
    Subjects will receive a single 0.5 mg semaglutide SC dose

Primary Outcome Measure

Type, incidence, and severity of treatment emergent adverse events (TEAEs), including assessment of application site skin sensitivity, vital signs, electrocardiograms (ECGs), and clinical laboratory results) [ Time Frame: From enrollment until approximately 5 weeks after the last dose of study drug ]

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion Clinical ResearchTempeArizona85283
Jacob Landolt
[email protected]
1-866-445-7033
Bridgette Blazek, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Celerion Clinical Research· Tempe, AZ

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