Obesity
Conditions
Brief summary
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.
Interventions
DRUGLiraglutide
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.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Inclusion criteria
1. Male or Female of Taiwanese patients, age above or equal to 12 years who are under Saxenda® treatment or are scheduled to treat with Saxenda® according to approved label in Taiwan based on the clinical judgment of their treating physician. 2. Patients should have baseline (pre-dosing) values, including body height, weight and initial dosage of Saxenda® . 3. The decision to initiate treatment or to have started with commercially available Saxenda® has been made by the patient/Legally Acceptable Representative (LAR) and the physician independently from the decision to join this study. 4. Informed consent obtained before collection of clinical data for this study. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
Exclusion criteria
1. Known or suspected hypersensitivity to Saxenda® , the active substance or any of the excipients 2. Previous participation in this study. Participation is defined as having given informed consent in this study. 3. Treatment with any investigational drug within 30 days prior to initiation of Saxenda® treatment. 4. Female patient who is pregnant, breast-feeding, or intends to become pregnant. 5. Patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). 6. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) by preferred term (PT) | From baseline (week 0) to week 26 | Percent(%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs) | From baseline (week 0) to week 26 | Number of events |
| Number of unexpected AEs and unexpected ADRs | From baseline (week 0) to week 26 | Number of events |
| Number of unexpected SAEs and unexpected SADRs | From baseline (week 0) to week 26 | Number of events |
| 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 | From baseline (week 0) to week 26 | Milligram(mg) |
| Body weight loss Percent (%) (Adult) | From baseline (week 0) to week 13 | Percent (%) |
| Body weight loss (%) (Adult) | From baseline (week 0) to week 26 | Percent (%) |
| Body weight loss Kilogram(Kg) (Adult) | From baseline (week 0) to week 13 | Kilogram(Kg) |
| Body weight loss (kg) (Adult) | From baseline (week 0) to week 26 | Kilogram(Kg) |
| The proportion of adult subjects losing at least 5% of baseline body weight | At Week 13 | Percent (%) |
| Number of adverse drug reaction (ADRs) | From baseline (week 0) to week 26 | Number of events |
| The proportion of losing at least 5% of baseline body weight from adult subjects whose maintenance dose of 3 mg, 12- week Saxenda® | At Week 26 | Percent (%) |
| Change in body mass index (BMI) (kg/m^2) (Adolescent) | From baseline (week 0) to week 13 | Kilogram(Kg) divided by meters squared(m2) |
| Change in body mass index (BMI) (%) (Adolescent) | From baseline (week 0) to week 13 | Percent (%) |
| Change in body mass index standard deviation score (BMI SDS) (Adolescent) | From baseline (week 0) to week 13 | Change in body mass index standard deviation score (BMI SDS) |
| Body weight loss (%) (Adolescent) | From baseline (week 0) to week 13 | Percent (%) |
| Body weight loss (kg) (Adolescent) | From baseline (week 0) to week 13 | Kilogram(Kg) |
| The proportion of adolescent subjects losing at least 4% of baseline BMI | At Week 13 | Percent(%) |
| The proportion of adolescent subjects losing at least 10% of baseline BMI | At Week 13 | Percent(%) |
| 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® | At Week 26 | Percent(%) |
| The proportion of adult subjects losing more than 10% of baseline body weight | At Week 13 | Percent (%) |
Countries
Taiwan
Outcome results
None listed