NCT07055607Enrolling By Invitation不适用
A Two-year Prospective, Observational Study of Wegovy in Real-world Clinical Practice
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,250
- 试验地点
- 32
- 主要终点
- Absolute change in body weight (kilograms [kg])
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Wegovy®
Participants will be treated with Wegovy according to the local labels in Spain, Switzerland and the United Kingdom (UK).
干预措施: Semaglutide (Drug)
结局指标
主要结局
Absolute change in body weight (kilograms [kg])
时间窗: From baseline (0 months) to the end of observation (24 months)
Measured in kg.
Percentage change in body weight (percentage [%])
时间窗: From baseline (0 months) to the end of observation (24 months)
Measured in %.
次要结局
- Absolute change in waist circumference (centimeters [cm])(From baseline (0 months) to the end of observation (24 months))
- Absolute change in waist-to-height ratio(From baseline (0 months) to the end of observation (24 months))
- Percentage change in waist circumference (%)(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)(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)(From baseline (0 months) to the end of observation (22 months))
- Number of participants who achieve >=10 percent body weight reduction (Yes/No)(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)(From baseline (0 months) to the end of observation (22 months))
- Number of participants who achieve >=15 percent body weight reduction (Yes/No)(From baseline (0 months) to the end of observation (24 months))
- Change in High Density Lipoprotein (HDL) Cholesterol (milligrams per decilitre [mg/dL])(From baseline (0 months) to the end of observation (24 months))
- Number of participants who achieve >=20 percent body weight reduction (Yes/No)(From baseline (0 months) to the end of observation (24 months))
- Change in percentage of participant in each Body Mass Index (BMI) category(From baseline (0 months) to the end of observation (24 months))
- Change in HDL Cholesterol (millimoles per litre [mmol/L])(From baseline (0 months) to the end of observation (24 months))
- Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL)(From baseline (0 months) to the end of observation (24 months))
- Change in LDL Cholesterol (mmol/L)(From baseline (0 months) to the end of observation (24 months))
- Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL)(From baseline (0 months) to the end of observation (24 months))
- Change in VLDL Cholesterol (mmol/L)(From baseline (0 months) to the end of observation (24 months))
- Change in Free Fatty Acid (FFA) (mmol/L)(From baseline (0 months) to the end of observation (24 months))
- Change in Triglycerides (mg/dL)(From baseline (0 months) to the end of observation (24 months))
- Change in Triglycerides (mmol/L)(From baseline (0 months) to the end of observation (24 months))
- Change in Glycated Haemoglobin (HbA1c) (%)(From baseline (0 months) to the end of observation (24 months))
- Change in systolic blood pressure(From baseline (0 months) to the end of observation (24 months))
- Change in diastolic blood pressure(From baseline (0 months) to the end of observation (24 months))
- Percentage change in the prevalence of obesity-related conditions(From baseline (0 months) to the end of observation (24 months))
- Percentage change in the total daily dosage of concomitant drugs (Yes/No)(From baseline (0 months) to the end of observation (24 months))
- Percentage change in the usage of additional treatments for weight loss (Yes/No)(From baseline (0 months) to the end of observation (24 months))
- Median time to Wegovy® maintenance dose(From baseline to the date of reported maintenance dose during the observation period (24 months))
- Median time to each Wegovy® dose escalation(Date from the start of the previous dose to the date of each subsequent escalation during the observation period (24 months))
- Maximum dose of Wegovy® for weight management(After baseline to any given time during the observation period (24 months))
- For UK and Spain: Change in percentage of participants on Wegovy® with each of drug-related adverse reaction(From baseline (0 months) to the end of observation (24 months))
- Median persistence time of Wegovy® treatment(From baseline (0 months) to the end of observation (24 months))
- Change in percentage of participants who discontinued(From baseline (0 months) to the end of observation (24 months))
- Percentage of participants who discontinued/withdrawn(From baseline (0 months) to the end of observation (24 months))
- For Switzerland: Percentage of participants who continued under reimbursement by basic mandatory health insurance (Yes/No)(From baseline (0 months) to the end of observation (22 months))
- For Switzerland: Percentage of participants who switched to out-of-pocket payment (or any other arrangement) (Yes/No)(From baseline (0 months) to the end of observation (22 months))
- For Switzerland: Percentage of participants who stopped treatment (Yes/No)(From baseline (0 months) to the end of observation (22 months))
- For Spain: Percentage of participants who have continued under out-of-pocket payment (Yes/No)(From baseline (0 months) to the end of observation (12 months))
- For Spain: Percentage of participants who have switched to reimbursement by the Public Health System (Yes/No)(From baseline (0 months) to the end of observation (12 months))
- For Switzerland: Change in percentage of participants fulfilling the necessary weight loss reimbursement criteria(From baseline (0 months) to the end of observation (22 months))
- Absolute change in the EQ Visual Analogue Score (EQ-VAS)(From baseline (0 months) to the end of observation (24 months))
- Absolute change in the EuroQoL-5-Dimension (5-Level) (EQ-5D-5L)(From baseline (0 months) to the end of observation (24 months))
- Absolute change in the Adelphi Adherence Questionnaire (ADAQ) score(From baseline (0 months) to the end of observation (24 months))
- Absolute change in treatment satisfaction questionnaire for medication 9 (TSQM-9) domain scores(From baseline (0 months) to the end of observation (24 months))
- Absolute change in percentage of work time missed (absenteeism) due to weight problem using Work Productivity and Activity Impairment Questionnaire (WPAI)(From baseline (0 months) to the end of observation (24 months))
- Absolute change in percentage of time impaired while working (presenteeism) due to weight problem using WPAI(From baseline (0 months) to the end of observation (24 months))
- Absolute change in percentage of activity impairment due to weight problem using WPAI(From baseline (0 months) to the end of observation (24 months))
研究者
研究点 (32)
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