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

NCT07673900 | Recruiting Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: VX-201-101
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight and/or Obesity

Keywords

first in human; Phase 1; randomized; single ascending dose; multiple dose; open label; pharmacokinetics; microarray patch; semaglutide

Outcome Measures

Primary Outcomes (1)

• 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)

  From enrollment until approximately 5 weeks after the last dose of study drug

Study Arms (6)

VX-201 0.25 mg SAD Phase

EXPERIMENTAL

Subjects will receive a single 0.25 mg VX-201 dose

Combination Product: VX-201

Single 0.25 mg semaglutide SC dose

ACTIVE COMPARATOR

Subjects will receive a single 0.25 mg semaglutide SC dose

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

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

Drug: semaglutide SC

Single VX-201 0.5 mg dose

EXPERIMENTAL

Subjects will receive a single 0.5 mg VX-201 dose

Combination Product: VX-201

Single semaglutide SC 0.5 mg dose

ACTIVE COMPARATOR

Subjects will receive a single 0.5 mg semaglutide SC dose

Drug: semaglutide SC

Interventions

VX-201 COMBINATION_PRODUCT

VX-201 is a needle free, shelf-stable, microneedle array patch (MAP) for delivery of semaglutide epi/intra-dermally

Also known as: Sema MAP

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 SC DRUG

Semaglutide is a long acting GLP-1 analogue with low renal clearance and an elimination half-life of approximately 7 days following subcutaneous administration.

Also known as: semaglutide, Wegovy

Multiple semaglutide SC 1.7 and 2.5 mg dose; Single 0.25 mg semaglutide SC dose; Single semaglutide SC 0.5 mg dose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Terrestrial Bio, Inc.: lead
• Celerion: collaborator

Study Sites (1)

Celerion Clinical Research

Tempe, Arizona, 85283, United States

RECRUITING

MeSH Terms

Interventions

semaglutide

Study Officials

• Bridgette Blazek, MD

  Celerion

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynda G Tussey, PhD

CONTACT

1-339-330-0088; lynda@terrestrialbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: June 29, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): February 10, 2027
• Study Completion (Estimated): May 18, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)