Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant

Официальное название

A Randomized, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Semaglutide Implant

Обзор

The study will evaluate the safety, tolerability and drug levels of a semaglutide implant placed just under the skin for a period of 4 weeks compared to 4 weekly injections of semaglutide (Wegovy) in overweight/obese participants who are otherwise healthy..

Подробное описание

This open label, randomized, parallel-group study will evaluate participants with a body mass index (BMI) between 27 and 40 kg/m2 (inclusive). Safety, tolerability and PK data will be collected and evaluated for the 4-week treatment period. Participants will undergo a Screening Visit and those who meet eligibility will be randomized (1:1) to one of 2 study groups:

* Group 1: Semaglutide Implant (NPM-139) * Group 2: Semaglutide 0.25 mg SC once weekly All participants will be domiciled for at least 48 hours following insertion of the implant (Group 1) or first dose of semaglutide 0.25 mg (Group 2).

Subsequently, participants will return to the clinic weekly until study end. At each of these visits, participants will have blood samples drawn for PK. After sample collections, site staff will administer semaglutide injections to participants in Group 2.

After 4 weeks of treatment (end of study), final PK samples will be collected and participants with implants will undergo a brief implant removal procedure under local anesthetic.

Вмешательства

• Комбинированный продукт Semaglutide Implant (NPM-139)
  Semaglutide Implant (NPM-139) is a drug/device combination product consisting of a subdermal titanium implant \~23 mm long and 2 mm in diameter, containing a sterile liquid formulation of semaglutide that is released from the implant at a substantially constant rate over at least 15 weeks.
• Препарат Semaglutide (Wegovy) weekly injection
  Semaglutide (Wegovy) is a clear, colorless solution provided as Wegovy FlexTouch four-dose pens: 0.25 mg/0.5 mL. It is injected SC in the abdomen, thigh or upper arm once/week.

Первичные конечные точки

• Area under the plasma concentration-time curve (AUC) [Срок оценки: 4 weeks]
• Maximum plasma concentration (Cmax) [Срок оценки: 4 weeks]
• Time to maximum semaglutide concentration (Tmax) [Срок оценки: 4 weeks]
• Adverse Events [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• BMI between 27 and 40 kg/m2 (inclusive)
• HbA1c </= 6.0% and FPG </+ 6.7 mmil/L
• eGFR >/= 60 mL/m2
• No significant health issues in the opinion of the Investigator that would preclude study participation, as determined by medical history and physical examination

Критерии исключения

• Type 1 or Type 2 Diabetesa
• A clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the Investigator
• Treatment with glucose lowering agent(s) within 3 months before Screening

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07430059 · VANI-NP-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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