Status
Completed
Phase
Not applicable
Enrollment
300
Locations
15
Results
Not posted
Publications
0
Study 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
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.
Timeline
First posted
Feb 28, 2024
Study start
Apr 8, 2024
Primary completion
Jan 13, 2025
Study completion
Jan 13, 2025
Results posted
Not reported
Registry updated
Jan 9, 2026
Outcomes
Incidence of adverse events (AEs) by preferred term (PT)
Time frame · From baseline (week 0) to week 26
Percent(%)
Number of adverse drug reaction (ADRs)
Time frame · From baseline (week 0) to week 26
Number of events
Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs)
Time frame · From baseline (week 0) to week 26
Number of events
Number of unexpected AEs and unexpected ADRs
Time frame · From baseline (week 0) to week 26
Number of events
Number of unexpected SAEs and unexpected SADRs
Time frame · 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
Time frame · From baseline (week 0) to week 26
Milligram(mg)
Body weight loss Percent (%) (Adult)
Time frame · From baseline (week 0) to week 13
Percent (%)
Body weight loss (%) (Adult)
Time frame · From baseline (week 0) to week 26
Percent (%)
Body weight loss Kilogram(Kg) (Adult)
Time frame · From baseline (week 0) to week 13
Kilogram(Kg)
Body weight loss (kg) (Adult)
Time frame · From baseline (week 0) to week 26
Kilogram(Kg)
The proportion of adult subjects losing at least 5% of baseline body weight
Time frame · At Week 13
Percent (%)
Eligibility
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
Study locations
Taiwan. Showing up to 24 locations stored in the fast local snapshot.
Changhua Christian Hospital_Metabolic Dept.
Changhua, Taiwan
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City, Taiwan
HsinChu MacKay Memorial Hospital
Hsinchu, Taiwan
HsinChu Municipal MacKay Children's Hospital
Hsinchu, Taiwan
Ton-Yen General Hospital
Hsinchu County, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
TZ Clinic
Pingtung County, Taiwan
China Medical University Hospital
Taichung, Taiwan
Kuang Tien General Hospital
Taichung, Taiwan
Tungs Taichung MetroHarbor Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
National Taiwan University Hospital_main
Taipei, Taiwan
Genesis Clinic
Taipei, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan
Publications
No PMID-linked publications were present in this registry snapshot.
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