Overweight and/or ObesityPhase 1NCT07673900
Semaglutide Delivered Epi-Intradermally by Microarray Patch (VX-201) Versus Subcutaneous Administration in Healthy Overweight and Obese Participants
A Phase 1 study testing VX-201 and semaglutide SC in people with Overweight and/or Obesity, run by Terrestrial Bio, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Overweight and/or Obesity
- What is being tested?
- VX-201 and semaglutide SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2026to 18 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- To be eligible for study participation, all subjects must meet all the following inclusion criteria:
- 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
- Age 18 to 60 years, inclusive, at the time of Screening
- 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
- 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
Who cannot join
- All subjects meeting any of the following criteria will be excluded from this study:
- Any disorder which in the investigator's opinion might jeopardize the subject's safety, evaluation of results, or compliance with the protocol
- Any of the following obesity or glycemia-related history:
- Treatment with a GLP-1 receptor agonist within 90 days before screening
- Treatment with any medication for the indication of obesity within the past 90 days before screening
- A self-reported change in body weight > 5 kg (11 lb) within 90 days before screening irrespective of medical records.
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- Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device
- HbA1c ≥ 6.5% as measured at screening
- History of type 1 or type 2 diabetes mellitus
- 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
- 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
- Estimated glomerular filtration rate <80 mL/min as determined by the Mosteller body surface area correction equation at Screening
- Have a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- Presence of acute pancreatitis within the past 90 days prior to the day of screening or history or presence of chronic pancreatitis
- 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
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method
- Any prescription medications (except for hormonal contraception associated with inhibition of ovulation as described Exclusion 9) within 14 days of Screening
- Previously participated in another dose level group in the study
- Known hypersensitivity to semaglutide
- 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
- 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
- Excessive tattoos, skin blemishes, or excessive hair near patch administration site
- 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
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Celerion Clinical Research
Tempe, Arizona, 85283
Site Director, 1-866-445-7033, studies@celerion.com
Bridgette Blazek, MD
About this study
Official title: 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.
- Conditions
- Overweight and/or Obesity
- Being tested
- VX-201, semaglutide SC
- Keywords
- first in human, Phase 1, randomized, single ascending dose, multiple dose, open label, pharmacokinetics, microarray patch, semaglutide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VX-201Combination product
Also called Sema MAP
VX-201 is a needle free, shelf-stable, microneedle array patch (MAP) for delivery of semaglutide epi/intra-dermally
semaglutide SCDrug
Also called semaglutide, Wegovy
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 group | Role | What they receive |
|---|---|---|
| VX-201 0.25 mg SAD Phase | Experimental | Subjects will receive a single 0.25 mg VX-201 dose Receives: Combination Product: VX-201 |
| Single 0.25 mg semaglutide SC dose | Active comparator | Subjects will receive a single 0.25 mg semaglutide SC dose Receives: Drug: semaglutide SC |
| Multiple VX-201 1.7 and 2.5 mg dose | Experimental | Subjects will receive four weekly 1.7 mg VX-201 doses followed by four weekly 2.4 mg VX-201 doses Receives: Combination Product: VX-201 |
| Multiple semaglutide SC 1.7 and 2.5 mg dose | Active comparator | Subjects will receive four weekly 1.7 mg of semaglutide SC doses followed by four weekly 2.4 mg semaglutide SC doses Receives: Drug: semaglutide SC |
| Single VX-201 0.5 mg dose | Experimental | Subjects will receive a single 0.5 mg VX-201 dose Receives: Combination Product: VX-201 |
| Single semaglutide SC 0.5 mg dose | Active comparator | Subjects will receive a single 0.5 mg semaglutide SC dose Receives: Drug: semaglutide SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From enrollment until approximately 5 weeks after the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start15 Jun 2026
- Primary completion10 Feb 2027 (estimated)
- Study completion18 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and/or ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Terrestrial Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Bridgette Blazek, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673900
- Sponsor's protocol ID
- VX-201-101
- Status last verified
- Jul 2026
- First submitted
- 21 Jun 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07673900
- Acronym / sponsor ID
- VX-201-101
- Conditions
- Overweight and/or Obesity
- Keywords
- first in human, Phase 1, randomized, single ascending dose, multiple dose, open label, pharmacokinetics, microarray patch
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Terrestrial Bio, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 10 Feb 2027 (estimated)
- Study completion
- 18 May 2027 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| VX-201 0.25 mg SAD Phase | Experimental | Combination Product: VX-201Subjects will receive a single 0.25 mg VX-201 dose |
| Single 0.25 mg semaglutide SC dose | Active comparator | Drug: semaglutide SCSubjects will receive a single 0.25 mg semaglutide SC dose |
| Multiple VX-201 1.7 and 2.5 mg dose | Experimental | Combination Product: VX-201Subjects will receive four weekly 1.7 mg VX-201 doses followed by four weekly 2.4 mg VX-201 doses |
| Multiple semaglutide SC 1.7 and 2.5 mg dose | Active comparator | Drug: semaglutide SCSubjects will receive four weekly 1.7 mg of semaglutide SC doses followed by four weekly 2.4 mg semaglutide SC doses |
| Single VX-201 0.5 mg dose | Experimental | Combination Product: VX-201Subjects will receive a single 0.5 mg VX-201 dose |
| Single semaglutide SC 0.5 mg dose | Active comparator | Drug: semaglutide SCSubjects will receive a single 0.5 mg semaglutide SC dose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- To be eligible for study participation, all subjects must meet all the following inclusion criteria:
Key exclusion criteria (25 listed)
- Any disorder which in the investigator's opinion might jeopardize the subject's safety, evaluation of results, or compliance with the protocol
- Any of the following obesity or glycemia-related history:
- 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
- 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
- Estimated glomerular filtration rate <80 mL/min as determined by the Mosteller body surface area correction equation at Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VX-201Also: Sema MAPVX-201 is a needle free, shelf-stable, microneedle array patch (MAP) for delivery of semaglutide epi/intra-dermally | Combination product | Multiple VX-201 1.7 and 2.5 mg dose, Single VX-201 0.5 mg dose, VX-201 0.25 mg SAD Phase |
| semaglutide SCAlso: semaglutide, WegovySemaglutide is a long acting GLP-1 analogue with low renal clearance and an elimination half-life of approximately 7 days following subcutaneous administration. | Drug | Multiple semaglutide SC 1.7 and 2.5 mg dose, Single 0.25 mg semaglutide SC dose, Single semaglutide SC 0.5 mg dose |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bridgette Blazek, MD principal investigator
Celerion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VX-201 and semaglutide SC in people with Overweight and/or Obesity, run by Terrestrial Bio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lynda G Tussey, PhD (1-339-330-0088, lynda@terrestrialbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.