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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1306-1595 | Other Identifier | WHO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Once weekly Wegovy | Participants will be treated with commercially available semaglutide. The treating physician will initiate treatment with commercially available semaglutide prior to and independently from the decision to include the participant in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Semaglutide injection will be self-administered once weekly subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in body weight | Percent (%) | From baseline (week 0) to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in body weight | Kilogram (kg) | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Percentage change in body weight | Percent (%) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be treated with commercially available semaglutide. The treating physician will initiate treatment with commercially available semaglutide prior to and independently from the decision to include the participant in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daejeon Endo Internal Medicine Clinic | Daejeon | 35220 | South Korea |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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| From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Achievement in body weight reduction more than or equal to (≥) 5% | Count of patients | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Achievement in body weight reduction ≥ 10% | Count of patients | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Achievement in body weight reduction ≥ 15% | Count of patients | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Achievement in body weight reduction ≥ 20% | Count of patients | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Change in body composition of Lean body mass | Kg | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Change in body composition of Total fat mass | Kg | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Change in body composition of Lean body mass | Percent (%) | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Change in body composition of Total fat mass | Percent (%) | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Change in Body mass index (BMI) | Kilogram per meter square (kg/m^2) | 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) | Count of patients | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Change in the proportion of patients by BMI Class II obesity (30 to 34.9 kg/m^2) | Count of patients | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Change in the proportion of patients by BMI Class III obesity (≥35 kg/m^2) | Count of patients | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Change in waist circumference | Centimetre (cm) | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Change in cardiometabolic parameters - Systolic blood pressure (SBP) | Millimetres of mercury (mmHg) | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Change in cardiometabolic parameters - Diastolic blood pressure (DBP) | mmHg | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Change in cardiometabolic parameters - Fasting plasma glucose (FPG) | Milligram per deciliter (mg/dL) | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Change in cardiometabolic parameters - Haemoglobin A1c (HbA1c) | Percent (%) | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Change in cardiometabolic parameters - Lipids: total cholesterol (TCh) | mg/dL | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Change in cardiometabolic parameters - Lipids: high-density lipoprotein cholesterol (HDL-C) | mg/dL | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Change in cardiometabolic parameters - Lipids: low-density lipoprotein cholesterol (LDL-C) | mg/dL | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Change in cardiometabolic parameters - Lipids: triglycerides (TG) | mg/dL | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Change in cardiometabolic parameters - Lipids: free fatty acid (FFA) | mg/dL | From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks |
| Change in status of type two diabetes mellitus (T2DM) | Count of patients | Baseline (week 0) to 52 weeks [or end of the study (EOS)] |
| Change in status of Hypertension | Count of patients | Baseline (week 0) to 52 weeks (or EOS) |
| Change in status of Dyslipidemia | Count of patients | Baseline (week 0) to 52 weeks (or EOS) |
| Number of treatment-emergent adverse events (TEAEs) | Count of events | From baseline (week 0) to 52 weeks (or EOS) |
| Number of serious TEAEs | Count of events | From baseline (week 0) to 52 weeks (or EOS) |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |