Obesity
Conditions
Brief summary
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.
Interventions
DRUGSemaglutide
Semaglutide injection will be self-administered once weekly subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). 2. 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. 3. Initiating treatment with Wegovy (semaglutide) for the first time and according to locally approved label. 4. Male or female, aged ≥ 19 years at the time of signing the informed consent.
Exclusion criteria
1. Previous participation in clinical studies including treatment with Wegovy (semaglutide). Participation is defined as providing informed consent in a previous study. 2. 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). 3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change in body weight | From baseline (week 0) to 24 weeks | Percent (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change in body weight | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | Kilogram (kg) |
| Percentage change in body weight | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | Percent (%) |
| Achievement in body weight reduction more than or equal to (≥) 5% | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | Count of patients |
| Achievement in body weight reduction ≥ 10% | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | Count of patients |
| Achievement in body weight reduction ≥ 15% | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | Count of patients |
| Achievement in body weight reduction ≥ 20% | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | Count of patients |
| Change in body composition of Lean body mass | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | Kg |
| Change in body composition of Total fat mass | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | Kg |
| Change in Body mass index (BMI) | From baseline (week 0) up to 8, 16, 24, 32, 40, 52 weeks | Kilogram per meter square (kg/m\^2) |
| Change in the proportion of patients by BMI Class I obesity (25 to 29.9 kg/m^2) | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | Count of patients |
| Change in the proportion of patients by BMI Class II obesity (30 to 34.9 kg/m^2) | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | Count of patients |
| Change in the proportion of patients by BMI Class III obesity (≥35 kg/m^2) | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | Count of patients |
| Change in waist circumference | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | Centimetre (cm) |
| Change in cardiometabolic parameters - Diastolic blood pressure (DBP) | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | mmHg |
| Change in cardiometabolic parameters - Fasting plasma glucose (FPG) | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | Milligram per deciliter (mg/dL) |
| Change in cardiometabolic parameters - Haemoglobin A1c (HbA1c) | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | Percent (%) |
| Change in cardiometabolic parameters - Lipids: total cholesterol (TCh) | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | mg/dL |
| Change in cardiometabolic parameters - Lipids: high-density lipoprotein cholesterol (HDL-C) | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | mg/dL |
| Change in cardiometabolic parameters - Lipids: low-density lipoprotein cholesterol (LDL-C) | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | mg/dL |
| Change in cardiometabolic parameters - Lipids: triglycerides (TG) | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | mg/dL |
| Change in cardiometabolic parameters - Lipids: free fatty acid (FFA) | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | mg/dL |
| Change in status of type two diabetes mellitus (T2DM) | Baseline (week 0) to 52 weeks [or end of the study (EOS)] | Count of patients |
| Change in status of Hypertension | Baseline (week 0) to 52 weeks (or EOS) | Count of patients |
| Change in status of Dyslipidemia | Baseline (week 0) to 52 weeks (or EOS) | Count of patients |
| Number of treatment-emergent adverse events (TEAEs) | From baseline (week 0) to 52 weeks (or EOS) | Count of events |
| Number of serious TEAEs | From baseline (week 0) to 52 weeks (or EOS) | Count of events |
| Change in cardiometabolic parameters - Systolic blood pressure (SBP) | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks | Millimetres of mercury (mmHg) |
Countries
South Korea
Outcome results
None listed