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

What Was Tested

The trial (phase 1) is built around Semaglutide.

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.

It had six arms (groups): one (experimental), one (active comparator), one (experimental), one (active comparator) and one (experimental).

The registry classes the interventions as combination product and drug.

Who Took Part

62 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: To be eligible for study participation, all subjects must meet all the following inclusion criteria:. 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.

The full record lists 5 inclusion and 24 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Semaglutide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2026-06-15 with completion listed for 2027-02-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (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).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 62 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.