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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1289-9747 | Other Identifier | World Health Organization (WHO) |
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This is a non-interventional study to evaluate the safety and effectiveness of Saxenda® in obese adults and adolescents in Taiwan. The participants will recieve Saxenda® treatment which is a medicine that doctors can already prescribe.
The study will last for about 26 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saxenda® | Patients with obesity treated with Saxenda® for weight management in routine clinical practice in Taiwan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | Participants will be treated with commercially available Saxenda® according to routine clinical practice at the discretion of the treating physician, following approved label in Taiwan. The decision to initiate treatment with commercially available Saxenda® has been made by the patient and the treating physician before and independently from the decision to participate in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) by preferred term (PT) | Percent(%) | From baseline (week 0) to week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse drug reaction (ADRs) | Number of events | From baseline (week 0) to week 26 |
| Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs) | Number of events |
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Inclusion Criteria:
Exclusion Criteria:
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Participants are patients with obesity treated with Saxenda® for weight management in routine clinical practice in Taiwan
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhua Christian Hospital_Metabolic Dept. | Changhua | 500 | Taiwan | |||
| Ditmanson Medical Foundation Chia-Yi Christian Hospital |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| From baseline (week 0) to week 26 |
| Number of unexpected AEs and unexpected ADRs | Number of events | From baseline (week 0) to week 26 |
| Number of unexpected SAEs and unexpected SADRs | Number of events | From baseline (week 0) to week 26 |
| Dose and exposure of liraglutide after initiation and reasons if not escalate to liraglutide 3.0 miligram (mg) for maintenance as specified in the product label | Milligram(mg) | From baseline (week 0) to week 26 |
| Body weight loss Percent (%) (Adult) | Percent (%) | From baseline (week 0) to week 13 |
| Body weight loss (%) (Adult) | Percent (%) | From baseline (week 0) to week 26 |
| Body weight loss Kilogram(Kg) (Adult) | Kilogram(Kg) | From baseline (week 0) to week 13 |
| Body weight loss (kg) (Adult) | Kilogram(Kg) | From baseline (week 0) to week 26 |
| The proportion of adult subjects losing at least 5% of baseline body weight | Percent (%) | At Week 13 |
| The proportion of adult subjects losing at least 5% of baseline body weight | Percent (%) | At Week 26 |
| The proportion of adult subjects losing more than 10% of baseline body weight | Percent (%) | At Week 13 |
| The proportion of adult subjects losing more than 10% of baseline body weight | Percent (%) | At Week 26 |
| The proportion of losing at least 5% of baseline body weight from adult subjects whose maintenance dose of 3 mg, 12- week Saxenda® | Percent (%) | At Week 26 |
| Change in body mass index (BMI) (kg/m^2) (Adolescent) | Kilogram(Kg) divided by meters squared(m2) | From baseline (week 0) to week 13 |
| Change in body mass index (BMI) (kg/m^2) (Adolescent) | Kilogram(Kg) divided by meters squared(m2) | From baseline (week 0) to week 26 |
| Change in body mass index (BMI) (%) (Adolescent) | Percent (%) | From baseline (week 0) to week 13 |
| Change in body mass index (BMI) (%) (Adolescent) | Percent (%) | From baseline (week 0) to week 26 |
| Change in body mass index standard deviation score (BMI SDS) (Adolescent) | Change in body mass index standard deviation score (BMI SDS) | From baseline (week 0) to week 13 |
| Change in body mass index standard deviation score (BMI SDS) (Adolescent) | Change in body mass index standard deviation(BMI SDS) | From baseline (week 0) to week 26 |
| Body weight loss (%) (Adolescent) | Percent (%) | From baseline (week 0) to week 13 |
| Body weight loss (%) (Adolescent) | Percent (%) | From baseline (week 0) to week 26 |
| Body weight loss (kg) (Adolescent) | Kilogram(Kg) | From baseline (week 0) to week 13 |
| Body weight loss (kg) (Adolescent) | Kilogram(Kg) | From baseline (week 0) to week 26 |
| The proportion of adolescent subjects losing at least 4% of baseline BMI | Percent(%) | At Week 13 |
| The proportion of adolescent subjects losing at least 4% of baseline BMI | Percent(%) | At Week 26 |
| The proportion of adolescent subjects losing at least 10% of baseline BMI | Percent(%) | At Week 13 |
| The proportion of adolescent subjects losing at least 10% of baseline BMI | Percent(%) | At Week 26 |
| The proportion of losing at least 4% of baseline BMI from adolescent subjects whose maintenance dose of 3 mg or maximum tolerated dose, 12- week Saxenda® | Percent(%) | At Week 26 |
| Chiayi City |
| 600 |
| Taiwan |
| HsinChu MacKay Memorial Hospital | Hsinchu | 300 | Taiwan |
| HsinChu Municipal MacKay Children's Hospital | Hsinchu | 300 | Taiwan |
| Ton-Yen General Hospital | Hsinchu County | 302 | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| TZ Clinic | Pingtung County | 900 | Taiwan |
| China Medical University Hospital | Taichung | 404 | Taiwan |
| Kuang Tien General Hospital | Taichung | 433 | Taiwan |
| Tungs Taichung MetroHarbor Hospital | Taichung | 435 | Taiwan |
| National Taiwan University Hospital | Taipei | 100229 | Taiwan |
| National Taiwan University Hospital_main | Taipei | 100 | Taiwan |
| Genesis Clinic | Taipei | 104 | Taiwan |
| Taipei Medical University Hospital | Taipei | 110 | Taiwan |
| Chang Gung Memorial Hospital, Linkou | Taoyuan | 333 | Taiwan |
| 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 |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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