Study to Evaluate the Safety and Effectiveness of Saxenda® for Weight Management in Routine Clinical Practice in Taiwan.

Completed

• Conditions: Obesity
• Interventions: Drug: Liraglutide

• Registration Number: NCT06283641
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-28
• Study Start: 2024-04-08
• Primary Completion: 2025-01-13
• Study Completion: 2025-01-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Saxenda®	Liraglutide	Patients with obesity treated with Saxenda® for weight management in routine clinical practice in Taiwan

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs) by preferred term (PT)	From baseline (week 0) to week 26	Percent(%)

Secondary Outcome Measures

Name	Time	Method
Body weight loss Percent (%) (Adult)	From baseline (week 0) to week 13	Percent (%)
Change in body mass index (BMI) (%) (Adolescent)	From baseline (week 0) to week 26	Percent (%)
Number of adverse drug reaction (ADRs)	From baseline (week 0) to week 26	Number of events
Body weight loss Kilogram(Kg) (Adult)	From baseline (week 0) to week 13	Kilogram(Kg)
Number of unexpected SAEs and unexpected SADRs	From baseline (week 0) to week 26	Number of events
Body weight loss (kg) (Adolescent)	From baseline (week 0) to week 26	Kilogram(Kg)
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
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 (%) (Adult)	From baseline (week 0) to week 26	Percent (%)
The proportion of adult subjects losing more than 10% of baseline body weight	At Week 26	Percent (%)
Change in body mass index (BMI) (kg/m^2) (Adolescent)	From baseline (week 0) to week 26	Kilogram(Kg) divided by meters squared(m2)
The proportion of adolescent subjects losing at least 4% of baseline BMI	At Week 26	Percent(%)
Body weight loss (kg) (Adult)	From baseline (week 0) to week 26	Kilogram(Kg)
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 (%)
The proportion of adult subjects losing at least 5% of baseline body weight	At Week 26	Percent (%)
The proportion of adolescent subjects losing at least 10% of baseline BMI	At Week 26	Percent(%)
Change in body mass index standard deviation score (BMI SDS) (Adolescent)	From baseline (week 0) to week 26	Change in body mass index standard deviation(BMI SDS)
Body weight loss (%) (Adolescent)	From baseline (week 0) to week 26	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(%)

Trial Locations

Locations (14)

Changhua Christian Hospital; 🇨🇳 Changhua City, Taiwan

HsinChu Municipal MacKay Children's Hospital; 🇨🇳 Hsinchu City, Taiwan

HsinChu MacKay Memorial Hospital; 🇨🇳 Hsinchu City, Taiwan

Ditmanson Medical Foundation Chia-Yi Christian Hospital; 🇨🇳 Chiayi City, Taiwan

Ton-Yen General Hospital; 🇨🇳 Hsinchu County, Taiwan

Kuang Tien General Hospital; 🇨🇳 Taichung City, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei City, Taiwan

Chang Gung Memorial Hospital Linkou; 🇨🇳 Taoyuan City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Genesis Clinic; 🇨🇳 Taipei City, Taiwan

TZ Clinic; 🇨🇳 Pingtung County, Taiwan

Taipei Medical University Hospital; 🇨🇳 Taipei city, Taiwan

Tungs Taichung MetroHarbor Hospital; 🇨🇳 Taichung city, Taiwan