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Recruiting NCT07673900

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

Conditions: Overweight and/or Obesity

Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 62
Sponsor: Terrestrial Bio, Inc.

Location: Celerion Clinical Research Tempe Arizona

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.

Eligibility Criteria

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 \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 \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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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07673900). StuddyBuddy aggregates publicly available trial information.