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Набор по приглашению NCT07280221

WEgovy Real World Assessment of Weight Loss in Korea

— Наблюдательное Obesity

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. 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

WEgovy Real World Assessment of Weight Loss in Korea (WE-WALK): a Multi-centre, Prospective, Single-arm, Nonintervention Study to Investigate the Effectiveness and Safety of Once-weekly Semaglutide 2.4 mg for People Living With Obesity in Routine Clinical Practice in Korea

Обзор

This study is to investigate the effectiveness and safety of Wegovy (semaglutide) in Korean patients living with obesity in routine clinical practice. The purpose of this study is to investigate the change in body weight and other clinical characteristics related to body weight in patients living with obesity. Participants will be treated with Wegovy (semaglutide) as prescribed by their doctor, in accordance with normal clinical practice. The study will last for about 52 weeks.

Вмешательства

  • Препарат Semaglutide
    Semaglutide injection will be self-administered once weekly subcutaneously.

Первичные конечные точки

  • Percentage change in body weight [Срок оценки: From baseline (week 0) to 24 weeks]
Вторичные конечные точки (12)
  • Absolute change in body weight [Срок оценки: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks]
  • Percentage change in body weight [Срок оценки: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks]
  • Achievement in body weight reduction more than or equal to (≥) 5% [Срок оценки: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks]
  • Achievement in body weight reduction ≥ 10% [Срок оценки: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks]
  • Achievement in body weight reduction ≥ 15% [Срок оценки: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks]
  • Achievement in body weight reduction ≥ 20% [Срок оценки: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks]
  • Change in body composition of Lean body mass [Срок оценки: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks]
  • Change in body composition of Total fat mass [Срок оценки: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks]
  • Change in body composition of Lean body mass [Срок оценки: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks]
  • Change in body composition of Total fat mass [Срок оценки: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks]
  • Change in Body mass index (BMI) [Срок оценки: From baseline (week 0) up to 8, 16, 24, 32, 40, 52 weeks]
  • Change in the proportion of patients by BMI Class I obesity (25 to 29.9 kg/m^2) [Срок оценки: From baseline (week 0) to 8, 16, 24, 32, 40, 52 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 Wegovy (semaglutide) has been made by the patient and the treating physician before and independently from the decision to include the patient in this study.
  • Initiating treatment with Wegovy (semaglutide) for the first time and according to locally approved label.
  • Male or female, aged ≥ 19 years at the time of signing the informed consent.

Критерии исключения

  • Previous participation in clinical studies including treatment with Wegovy (semaglutide). Participation is defined as providing informed consent in a previous study.
  • Female patient 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 co-operation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

South Korea · 1 центр
  • Daejeon Endo Internal Medicine Clinic — Daejeon

Идентификаторы

NCT: NCT07280221 · NN9536-7850 · U1111-1306-1595

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗