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Compares treatment options for Overweight and/or Obesity
Official title Semaglutide Delivered Epi-Intradermally by Microarray Patch (VX-201) Versus Subcutaneous Administration in Healthy Overweight and Obese Participants
ClinicalTrials.gov ID: NCT07673900
What this study is testing
What is VX-201?
VX-201 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for overweight and/or obesity.
Also referred to as Sema MAP.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- To be eligible for study participation, all people must meet all the following
- Medically healthy with no clinically significant medical history, vital sign, or coagulation results at Screening; chemistry, hematology, or...
- 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...
You likely can't join if
- All people 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.
See the full eligibility criteria
- To be eligible for study participation, all people must meet all the following
- 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...
- 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
- All people 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.
- 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...
- Have a significant history of or current cardiovascular (myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, hepatic, renal, gastrointestinal (GI)...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tempe, Arizona, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tempe, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.