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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1308-1428 | Other Identifier | World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wegovy® | Participants will be treated with Wegovy according to the local labels in Spain, Switzerland and the United Kingdom (UK). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in body weight (kilograms [kg]) | Measured in kg. | From baseline (0 months) to the end of observation (24 months) |
| Percentage change in body weight (percentage [%]) | Measured in %. | From baseline (0 months) to the end of observation (24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in waist circumference (centimeters [cm]) | Measured in cm. | From baseline (0 months) to the end of observation (24 months) |
| Absolute change in waist-to-height ratio | Measured as ratio. |
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Inclusion criteria:
Exclusion criteria:
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Participants will be treated with Wegovy according to the local labels in Spain, Switzerland and the United Kingdom (UK).
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAP Sarrià | Barcelona | 08017 | Spain | |||
| CAP Sants |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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| From baseline (0 months) to the end of observation (24 months) |
| Percentage change in waist circumference (%) | Measured in %. | 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) | Measured as count of participants. | 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) | Measured as count of participants. | From baseline (0 months) to the end of observation (22 months) |
| Number of participants who achieve >=10 percent body weight reduction (Yes/No) | Measured as count of participants. | 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) | Measured as count of participants. | From baseline (0 months) to the end of observation (22 months) |
| Number of participants who achieve >=15 percent body weight reduction (Yes/No) | Measured as count of participants. | From baseline (0 months) to the end of observation (24 months) |
| Number of participants who achieve >=20 percent body weight reduction (Yes/No) | Measured as count of participants. | From baseline (0 months) to the end of observation (24 months) |
| Change in percentage of participant in each Body Mass Index (BMI) category | Measured as count of participants. | From baseline (0 months) to the end of observation (24 months) |
| Change in High Density Lipoprotein (HDL) Cholesterol (milligrams per decilitre [mg/dL]) | Measured in mg/dL. | From baseline (0 months) to the end of observation (24 months) |
| Change in HDL Cholesterol (millimoles per litre [mmol/L]) | Measured in mmol/L. | From baseline (0 months) to the end of observation (24 months) |
| Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL) | Measured in mg/dL. | From baseline (0 months) to the end of observation (24 months) |
| Change in LDL Cholesterol (mmol/L) | Measured in mmol/L. | From baseline (0 months) to the end of observation (24 months) |
| Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) | Measured in mg/dL. | From baseline (0 months) to the end of observation (24 months) |
| Change in VLDL Cholesterol (mmol/L) | Measured in mmol/L. | From baseline (0 months) to the end of observation (24 months) |
| Change in Free Fatty Acid (FFA) (mmol/L) | Measured in mmol/L. | From baseline (0 months) to the end of observation (24 months) |
| Change in Triglycerides (mg/dL) | Measured in mg/dL. | From baseline (0 months) to the end of observation (24 months) |
| Change in Triglycerides (mmol/L) | Measured in mmol/L. | From baseline (0 months) to the end of observation (24 months) |
| Change in Glycated Haemoglobin (HbA1c) (%) | Measured in %. | From baseline (0 months) to the end of observation (24 months) |
| Change in systolic blood pressure | Measured in millimeter of mercury (mmHg). | From baseline (0 months) to the end of observation (24 months) |
| Change in diastolic blood pressure | Measured in mmHg. | From baseline (0 months) to the end of observation (24 months) |
| Percentage change in the prevalence of obesity-related conditions | Obesity-related conditions will be assessed as Yes/No in the following categories: Myocardial infarction (MI), Stroke, Heart failure with reduced Ejection Fraction (HFrEF) and Heart Failure with preserved Ejection Fraction (HFpEF), Atherosclerotic cardiovascular disease (ASCVD) defined as at least one of coronary artery disease, peripheral artery disease, cerebrovascular disease and atherosclerosis, Metabolic dysfunction-associated steatotic liver disease (MASLD), Metabolic dysfunction-associated steatohepatitis (MASH), Chronic kidney disease (CKD), Obstructive sleep apnoea, Poly-cystic ovary syndrome (PCOS), Infertility, Urinary incontinence, Lower back pain, Knee / hip oste-oarthritis, Musculoskeletal pain, Asthma, Chronic Obstructive Pulmonary Disease (COPD), Clini-cian-diagnosed mood disorder, Clinician-diagnosed eating disorder. | From baseline (0 months) to the end of observation (24 months) |
| Percentage change in the total daily dosage of concomitant drugs (Yes/No) | Total daily dosage of concomitant drugs were assessed as Yes/No among the following: Antidiabetic medication, Antihypertensive medication, Lipid-lowering medication, Pain medica-tion, Psychotropic medication, Antithrombotic agents, Thyroid hormone medication, Proton pump inhibitor. | From baseline (0 months) to the end of observation (24 months) |
| Percentage change in the usage of additional treatments for weight loss (Yes/No) | Usage of additional treatments for weight loss will be assessed as Yes/No among the following: Bariatric surgery, Clinical practice / healthcare-provided diet plan, Alternative diet plan, Exercise regime, Behavioural and alternative therapy, Digital health app. | From baseline (0 months) to the end of observation (24 months) |
| Median time to Wegovy® maintenance dose | Measured in weeks. | From baseline to the date of reported maintenance dose during the observation period (24 months) |
| Median time to each Wegovy® dose escalation | Measured in weeks. | 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 | Measured in milligrams (mg). | 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 | Measured as percentage of participants. | From baseline (0 months) to the end of observation (24 months) |
| Median persistence time of Wegovy® treatment | Measured in weeks. | From baseline (0 months) to the end of observation (24 months) |
| Change in percentage of participants who discontinued | Measured as percentage of participants. | From baseline (0 months) to the end of observation (24 months) |
| Percentage of participants who discontinued/withdrawn | Measured as percentage of participants. Reason for discountinued/withdrawn due to Lack of efficacy as per reimbursement criteria (UK, CH only), Lack of efficacy as per clinical judgment, Lack of efficacy as per subject's judgment, Non-serious gastro intestinal event (nausea, vomiting, diarrhea, constipation and/or abdominal pain), Adverse reaction ((AR) not otherwise specified in the listed reasons), Patient's request, Pregnancy,Financial constraints (cost of medication, change in eligibility for reimbursement) (CH and ES only), Reaching a BMI of less than (<) 25 kilograms per meter square (kg/m^2), death and other. | 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) | Measured as percentage of participants. | 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) | Measured as percentage of participants. | From baseline (0 months) to the end of observation (22 months) |
| For Switzerland: Percentage of participants who stopped treatment (Yes/No) | Measured as percentage of participants. | 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) | Measured as percentage of participants. | 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) | Measured as percentage of participants. | 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 | Measured as percentage of participants. | From baseline (0 months) to the end of observation (22 months) |
| Absolute change in the EuroQoL-5-Dimension (5-Level) (EQ-5D-5L) | EQ-5D-5L consists of 2 components, EQ-5D descriptive system and EQ visual analogue scale (EQ-VAS). EQ-5D 5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension will have 5 levels: no, slight, moderate, severe and extreme problems. Respondent is asked to indicate the health state by ticking the box next to the most appropriate statement in each of the five dimensions. Decision will result in a 1-digit number that expresses the level for that dimension. Digits for five dimensions can be combined into a 5-digit number that describes patient's health state. EQ-5D health states can be converted into a single summary number (index value) which will reflect how good/bad a health state is according to valuation set in general population of a country/region. Index score records an average health status according to dimensions using an algorithm,ranges 0-1 with higher score indicating better health status. | From baseline (0 months) to the end of observation (24 months) |
| Absolute change in the EQ Visual Analogue Score (EQ-VAS) | Measured as score points. The EQ-VAS will record the respondent's self-rated health on a vertical visual analogue scale. The scale is numbered from 0 to 100, with lower score indicating worst health and higher score indicating best health. | From baseline (0 months) to the end of observation (24 months) |
| Absolute change in the Adelphi Adherence Questionnaire (ADAQ) score | Measured as score points. ADAQ is an 11-item instrument that measures adherence to medication. The instrument includes 4 items that assess adherence behaviours and 7 items that assess drivers of non adherence. Each item yields a score ranging from 0 to 4 and item scores are then averaged to produce the ADAQ score. The ADAQ score is a measure of medication adherence ranging from 0 to 4, with lower scores representing greater adherence. | From baseline (0 months) to the end of observation (24 months) |
| Absolute change in treatment satisfaction questionnaire for medication 9 (TSQM-9) domain scores | Measured as score points. TSQM-9 is a 9-item instrument that measures a patient's satisfaction with their medication. The instrument assesses three domains: effectiveness, convenience and global satisfaction. Each domain will produce a score ranging from 0 to 100, with higher scores reflecting higher satisfaction on that domain. | 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) | Measured as score points. WPAI is a self-administered instrument used to assess the impact of disease on work productivity and regular activities during the past seven days. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, that is, worse outcomes. | 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 | Measured as score points. WPAI is a self-administered instrument used to assess the impact of disease on work productivity and regular activities during the past seven days. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, that is, worse outcomes. | From baseline (0 months) to the end of observation (24 months) |
| Absolute change in percentage of activity impairment due to weight problem using WPAI | Measured as score points. WPAI is a self-administered instrument used to assess the impact of disease on work productivity and regular activities during the past seven days. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, that is, worse outcomes. | From baseline (0 months) to the end of observation (24 months) |
| Barcelona |
| 08028 |
| Spain |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Centro de Salud Cartagena Casco Antiguo | Cartagena | 30201 | Spain |
| Hospital Vithas Sevilla | Castilleja de la Cuesta | 41950 | Spain |
| Hospital Univ. Virgen de la Arrixaca | El Palmar (Murcia) | 30120 | Spain |
| Clínica de Endocrinología y Nutrición Dr. Bellido | Ferrol | 15401 | Spain |
| Ginegetafe S.L. | Getafe (Madrid) | 28901 | Spain |
| Centro de Salud La Cuesta | La Cuesta (Santa Cruz de Tenerife) | 38320 | Spain |
| Hospital Univ. de Gran Canaria Doctor Negrín | Las Palmas de Gran Canaria | 35010 | Spain |
| Hospital Universitario Sanitas Virgen del Mar | Madrid | 28016 | Spain |
| Hospital Quirónsalud Málaga | Málaga | 29004 | Spain |
| Hospital Univ. Central de Asturias | Oviedo | 33011 | Spain |
| Hospital Son Espases | Palma de Mallorca | 07120 | Spain |
| Hospiten Roca_Ginecología | San Bartolomé de Tirajana (Las Palmas) | 35100 | Spain |
| Praxis Dr. Schäfer, Bern | Bern | 3013 | Switzerland |
| Hôpitaux Universitaires de Genève HUG | Geneva | 1211 | Switzerland |
| Luzerner Kantonsspital | Lucerne | 6004 | Switzerland |
| Clinica Moncucco | Lugano | 6900 | Switzerland |
| Centre médical de l'obésité et du diabète | Neuchâtel | 2000 | Switzerland |
| Kantonsspital Olten | Olten | 4600 | Switzerland |
| Praxis Prof. Dr. med. G. Rudofsky | Olten | 4600 | Switzerland |
| Stoffwechselzentrum St. Gallen | Sankt Gallen | 9016 | Switzerland |
| Universitätsspital Zürich | Zurich | 8091 | Switzerland |
| Sandwell Health Campus | West Bromwich | West Midlands | B71 4HJ | United Kingdom |
| Barnsley Hospital | Barnsley | S75 2EP | United Kingdom |
| Hull Royal Infirmary | Hull | HU3 2JZ | United Kingdom |
| St Thomas' Hospital - Diabetes | London | SE1 7EH | United Kingdom |
| Luton and Dunstable University Hospital | Luton | LU4 0DZ | United Kingdom |
| St George's Hospital | Tooting | SW17 0RE | United Kingdom |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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