A Two-year Prospective, Observational Study of Wegovy in Real-world Clinical Practice

Обзор

This observational study will explore how Wegovy® (Semaglutide) is used in everyday situations, how it might affect things like weight, body mass index (BMI) and waist circumference, and what kind of impact it could have on overall quality of life. The overall purpose of this study is to understand how Wegovy impacts weight when used as part of regular medical care. Participants will be treated with Wegovy as prescribed to the participant by their doctor, in accordance with normal clinical practice. The study will last for about two years.

Вмешательства

• Препарат Semaglutide
  Participants will be treated with commercially available Wegovy according to routine clinical practice and is purely at the discretion of the treating physician. Only individuals receiving Wegovy reimbursed by the healthcare system in their respective countries are included in the study.

Первичные конечные точки

• Absolute change in body weight (kilograms [kg]) [Срок оценки: From baseline (0 months) to the end of observation (24 months)]
• Percentage change in body weight (percentage [%]) [Срок оценки: From baseline (0 months) to the end of observation (24 months)]

Вторичные конечные точки (12)

• Absolute change in waist circumference (centimeters [cm]) [Срок оценки: From baseline (0 months) to the end of observation (24 months)]
• Absolute change in waist-to-height ratio [Срок оценки: From baseline (0 months) to the end of observation (24 months)]
• Percentage change in waist circumference (%) [Срок оценки: From baseline (0 months) to the end of observation (24 months)]
• Number of participants who achieve greater than or equal to (>=) 5 percent body weight reduction (Yes/No) [Срок оценки: From baseline (0 months) to the end of observation (24 months)]
• For Switzerland: Number of participants who achieve >=7 percent body weight reduction (Yes/No) [Срок оценки: From baseline (0 months) to the end of observation (22 months)]
• Number of participants who achieve >=10 percent body weight reduction (Yes/No) [Срок оценки: From baseline (0 months) to the end of observation (24 months)]
• For Switzerland: Number of participants who achieve >=12 percent body weight reduction (Yes/No) [Срок оценки: From baseline (0 months) to the end of observation (22 months)]
• Number of participants who achieve >=15 percent body weight reduction (Yes/No) [Срок оценки: From baseline (0 months) to the end of observation (24 months)]
• Number of participants who achieve >=20 percent body weight reduction (Yes/No) [Срок оценки: From baseline (0 months) to the end of observation (24 months)]
• Change in percentage of participant in each Body Mass Index (BMI) category [Срок оценки: From baseline (0 months) to the end of observation (24 months)]
• Change in High Density Lipoprotein (HDL) Cholesterol (milligrams per decilitre [mg/dL]) [Срок оценки: From baseline (0 months) to the end of observation (24 months)]
• Change in HDL Cholesterol (millimoles per litre [mmol/L]) [Срок оценки: From baseline (0 months) to the end of observation (24 months)]

Критерии участия

Критерии включения

• Signed consent obtained before any study-related activities (study-related activities are any pro-cedure related to recording of data according to the protocol).
• Are eligible for Wegovy and are due to initiate treatment for the first time within the study period; the decision to initiate treatment with commercially available Wegovy has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
• Male or female, age above or equal to 18 years at time of signing informed consent.
• Have at least one reported weight measurement documented at baseline or within 28 days prior to baseline.
• Participants must be able to complete the electronic patient reported outcome (ePRO) questionnaires on a compatible electronic device with internet access.
• Fulfil the respective reimbursement criteria in the visit prior to / at baseline in Switzerland and United Kingdom (UK).

Критерии исключения

• Previous participation in this study. Participation is defined as having given informed consent in this study.
• Presence of a documented refusal or unwillingness to participate in research.
• Previous treatment with other obesity management pharmacotherapy or any glucagon like pep-tide-1 (GLP- 1) receptor agonist up to 90 days prior to baseline in Switzerland and UK.
• Previous treatment with other obesity management pharmacotherapy or any GLP- 1 receptor agonist up to 30 days prior to baseline in Spain.
• Pregnant or women of childbearing potential and not using a highly effective contraceptive method.
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation with the study requirements.
• Individuals who have reported plans to move out in the next 12 months to an area not serviced by their current site.
• Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) in Spain and UK.
• Participant has had a prior serious allergic reaction to semaglutide or any of the ingredients in Wegovy.
• Have had Saxenda reimbursed by basic mandatory health insurance for a cumulative period of more than 12 months prior to baseline in Switzerland.
• Documented history of diabetes mellitus type 1 and type 2 in Spain.
• Presence of diabetic complications and/or at risk of hypoglycaemia (with a documented history of frequent hypoglycaemia) in Spain.

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

Испания · 15 центров

• CAP Sarrià — Barcelona
• CAP Sants — Barcelona
• Hospital Vall d'Hebron — Barcelona
• Centro de Salud Cartagena Casco Antiguo — Cartagena
• Hospital Vithas Sevilla — Castilleja de la Cuesta
• Hospital Univ. Virgen de la Arrixaca — El Palmar (Murcia)
• Clínica de Endocrinología y Nutrición Dr. Bellido — Ferrol
• Ginegetafe S.L. — Getafe (Madrid)
• … и ещё 7 центров

Швейцария · 9 центров

• Praxis Dr. Schäfer, Bern — Bern
• Hôpitaux Universitaires de Genève HUG — Geneva
• Luzerner Kantonsspital — Lucerne
• Clinica Moncucco — Lugano
• Centre médical de l'obésité et du diabète — Neuchâtel
• Kantonsspital Olten — Olten
• Praxis Prof. Dr. med. G. Rudofsky — Olten
• Stoffwechselzentrum St. Gallen — Sankt Gallen
• … и ещё 1 центр

Великобритания · 6 центров

• Sandwell Health Campus — West Bromwich
• Barnsley Hospital — Barnsley
• Hull Royal Infirmary — Hull
• St Thomas' Hospital - Diabetes — London
• Luton and Dunstable University Hospital — Luton
• St George's Hospital — Tooting

Идентификаторы

NCT: NCT07055607 · NN9536-8189 · U1111-1308-1428

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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