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

June 24, 2026 updated by: Terrestrial Bio, Inc.

A Randomized, Phase 1 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Epi/Intra-dermally Administered Semaglutide (VX-201) Compared to Subcutaneous Administration in Healthy Overweight and Obese Participants: Single and Multiple Dose Assessment

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Recruiting
        • Celerion Clinical Research
        • Contact:
        • Principal Investigator:
          • Bridgette Blazek, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • To be eligible for study participation, all subjects must meet all the following inclusion criteria:

    1. Medically healthy with no clinically significant medical history, vital sign, or coagulation results at Screening; chemistry, hematology, or urinalysis at Screening and Day -1 (SAD)/Day 0 (MD) as deemed by the Investigator
    2. Age 18 to 60 years, inclusive, at the time of Screening
    3. Body mass index ≥25 to <35 kg/m2 if participating in the SAD phase or ≥27 to <40 kg/m2 if participating in the MD phase, at the time of Screening
    4. Must be able to communicate well with the Investigator, understand and comply with the requirements of the study (including required confinement periods), and understand and provide written consent

Exclusion Criteria:

All subjects meeting any of the following criteria will be excluded from this study:

  1. Any disorder which in the investigator's opinion might jeopardize the subject's safety, evaluation of results, or compliance with the protocol

  2. Any of the following obesity or glycemia-related history:

    1. Treatment with a GLP-1 receptor agonist within 90 days before screening
    2. Treatment with any medication for the indication of obesity within the past 90 days before screening
    3. A self-reported change in body weight > 5 kg (11 lb) within 90 days before screening irrespective of medical records.
    4. Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device
    5. HbA1c ≥ 6.5% as measured at screening
    6. History of type 1 or type 2 diabetes mellitus
  3. Have a history of heart block, or a pulse rate (PR) interval >200 milliseconds (msec), or any abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
  4. Have a significant history of or current cardiovascular (myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study medication, or interfering with the interpretation of data
  5. Estimated glomerular filtration rate <80 mL/min as determined by the Mosteller body surface area correction equation at Screening
  6. Have a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
  7. Presence of acute pancreatitis within the past 90 days prior to the day of screening or history or presence of chronic pancreatitis
  8. Active malignancy or history of malignancy of any organ system (other than localized squamous cell or basal cell carcinoma of the skin that have been excised or resolved), treated or untreated, within the past 5 years
  9. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method
  10. Any prescription medications (except for hormonal contraception associated with inhibition of ovulation as described Exclusion 9) within 14 days of Screening
  11. Previously participated in another dose level group in the study
  12. Known hypersensitivity to semaglutide
  13. Known or suspected alcohol or drugs/chemical substance abuse within one year prior to the day of screening, or positive drug or alcohol screen results at Screening or Day-1
  14. Positive result for human immunodeficiency virus (HIV) or presence of actively replicating viral hepatitis due to hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at Screening
  15. Excessive tattoos, skin blemishes, or excessive hair near patch administration site
  16. Participation in any clinical study with an investigational or approved drug/device within 30 days or 5 half-lives (whichever is longer) before Screening or is planning to participate in another clinical study while enrolled in this study
  17. Donated or lost >200 mL of blood within 60 days before Day -1, donated plasma within 7 days before Day -1, or plans to donate blood or plasma during the study
  18. Is directly affiliated with the study at the study site or is an immediate family member (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the study site, or is employed by Terrestrial Bio (that is an employee, temporary contract worker, or designee responsible for the conduct of the study) or is an immediate family member of an employee of Terrestrial Bio

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VX-201 0.25 mg SAD Phase
Subjects will receive a single 0.25 mg VX-201 dose
Combination product: VX-201
VX-201 is a needle free, shelf-stable, microneedle array patch (MAP) for delivery of semaglutide epi/intra-dermally
Other Names:
  • Sema MAP
Active Comparator: Single 0.25 mg semaglutide SC dose
Subjects will receive a single 0.25 mg semaglutide SC dose
Drug: semaglutide SC
Semaglutide is a long acting GLP-1 analogue with low renal clearance and an elimination half-life of approximately 7 days following subcutaneous administration.
Other Names:
  • Wegovy
  • semaglutide
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
Combination product: VX-201
VX-201 is a needle free, shelf-stable, microneedle array patch (MAP) for delivery of semaglutide epi/intra-dermally
Other Names:
  • Sema MAP
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
Drug: semaglutide SC
Semaglutide is a long acting GLP-1 analogue with low renal clearance and an elimination half-life of approximately 7 days following subcutaneous administration.
Other Names:
  • Wegovy
  • semaglutide
Experimental: Single VX-201 0.5 mg dose
Subjects will receive a single 0.5 mg VX-201 dose
Combination product: VX-201
VX-201 is a needle free, shelf-stable, microneedle array patch (MAP) for delivery of semaglutide epi/intra-dermally
Other Names:
  • Sema MAP
Active Comparator: Single semaglutide SC 0.5 mg dose
Subjects will receive a single 0.5 mg semaglutide SC dose
Drug: semaglutide SC
Semaglutide is a long acting GLP-1 analogue with low renal clearance and an elimination half-life of approximately 7 days following subcutaneous administration.
Other Names:
  • Wegovy
  • semaglutide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From enrollment until approximately 5 weeks after the last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Terrestrial Bio, Inc.

Collaborators

Celerion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2026

Primary Completion (Estimated)

February 10, 2027

Study Completion (Estimated)

May 18, 2027

Study Registration Dates

First Submitted

June 21, 2026

First Submitted That Met QC Criteria

June 24, 2026

First Posted (Actual)

June 29, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX-201-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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