No-Needle weight loss patch enters human testing
NCT ID NCT07673900
First seen Jun 29, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This early-stage study tests a new way to deliver semaglutide—a drug used for weight management—using a small, needle-free patch that sticks to the skin. The patch, called VX-201, aims to provide the same benefits as injections without the need for needles. The trial includes healthy adults who are overweight or obese and compares the patch to standard semaglutide injections to see if it is safe and how well the drug enters the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- semaglutide (delivered via microneedle patch)
- What this could lead to
- If successful, this could offer a needle-free alternative to daily or weekly injections for weight management, making treatment easier and more comfortable.
- What could go wrong
- This is an early Phase 1 study focused on safety and dosing, so it is too soon to know if the patch works as well as injections. Skin reactions or inconsistent drug absorption are possible risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 62 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Celerion Clinical Research
RECRUITINGTempe, Arizona, 85283, United States
Contact Email: •••••@•••••
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