Study S001981

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 record

Registration

Registration: NCT07673900
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: RECRUITING
Enrollment: 62
Start: 2026-06-15
Primary completion: 2027-02-10
Lead sponsor: Terrestrial Bio, Inc.
Conditions: Overweight and/or Obesity
Interventions: COMBINATION_PRODUCT:VX-201; DRUG:semaglutide SC
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

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]

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