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

Официальное название

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

Обзор

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.

Вмешательства

• Комбинированный продукт VX-201
  VX-201 is a needle free, shelf-stable, microneedle array patch (MAP) for delivery of semaglutide epi/intra-dermally
• Препарат semaglutide SC
  Semaglutide is a long acting GLP-1 analogue with low renal clearance and an elimination half-life of approximately 7 days following subcutaneous administration.

Первичные конечные точки

• 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) [Срок оценки: From enrollment until approximately 5 weeks after the last dose of study drug]

Критерии участия

Критерии включения

• To be eligible for study participation, all subjects must meet all the following inclusion criteria:

• 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

Критерии исключения

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
• 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 enrolled in this study
• 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 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Celerion Clinical Research — Tempe

Идентификаторы

NCT: NCT07673900 · VX-201-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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