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Набор по приглашению NCT07018544

A Multicentre, Prospective, Single-arm, Non-interventional Regulatory Post-marketing Surveillance (rPMS) Study to Investigate the Safety and Effectiveness of Wegovy® (Semaglutide) in Patients With Obesity and Patients With Overweight in Routine Clinical Practice in Korea

— Наблюдательное Obesity and Overweight

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: semaglutide.
Кому может быть актуально
Состояния в реестре: Obesity and Overweight. Базовые параметры: от 19 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Multicentre, Prospective, Single-arm, Non-interventional Regulatory Post-marketing Surveillance (rPMS) Study to Investigate the Safety and Effectiveness of Wegovy® (Semaglutide) in Patients With Obesity and Patients With Overweight in Routine Clinical Practice in Korea.

Обзор

This study is conducted to investigate the safety and effectiveness of semaglutide in participants with obesity and overweight in routine clinical practice. Participants will get semaglutide as prescribed by a doctor. This study will last for about 4 years and participants will participate in the study for approximately 26 weeks.

Вмешательства

  • Другое semaglutide
    Participants will be treated with commercially available semaglutide according to routine clinical practice at the discretion of the treating physician.

Первичные конечные точки

  • Number (incidence) of AEs [Срок оценки: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
Вторичные конечные точки (12)
  • Number (incidence) of ADRs [Срок оценки: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • Number (incidence) of SAEs [Срок оценки: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • Number (incidence) of SADRs [Срок оценки: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • Number (incidence) of unexpected AEs [Срок оценки: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • Number (incidence) of unexpected ADRs [Срок оценки: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • Number (incidence) of unexpected SAEs [Срок оценки: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • Number (incidence) of unexpected SADRs [Срок оценки: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • Total dose of semaglutide [Срок оценки: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • Body weight loss [Срок оценки: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • Body weight loss [Срок оценки: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • The proportion of participants losing greater than or equal to 5% body weight [Срок оценки: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • The proportion of participants losing greater than or equal to 10% body weight [Срок оценки: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]

Критерии участия

Критерии включения

  • Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
  • The decision to initiate treatment with commercially available semaglutide has been made by the participants and the treating physician before and independently from the decision to include the participant in this study.
  • Male or female adults, age above or equal to 19 years who is scheduled to start treatment with semaglutide based on the clinical judgment of their treating physician as specified in the Korean-prescribing Information (approved label in Korea) at the time of signing informed consent.

Критерии исключения

  • Participants who are or have previously been on semaglutide therapy before enrollment.
  • Known or suspected hypersensitivity to the active substance or any of the excipients of semaglutide.
  • Previous participation in this study. Participation is defined as having given informed consent in this study.
  • Female participant who is pregnant, breast-feeding, or intends to become pregnant and is of childbearing potential not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice).
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

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

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

South Korea · 8 центров
  • MyongJi Hospital — Goyang-si
  • Kosin University Gospel Hospital — Busan
  • Yonsei Hanaro Clinic — Chungcheongnam-do
  • Daejeon Endo Internal Medicine Clinic — Daejeon
  • Ajou University Hospital — Gyeonggi-do
  • Samsung Medical Center — Seoul
  • Hplus Yangji Hospital — Seoul
  • Pusan National University Yangsan Hospital — Yangsan

Идентификаторы

NCT: NCT07018544 · NN9536-7543 · U1111-1281-9419

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗