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

NCT06283641 | Completed

• 2 other identifiers: NN8022-7780U1111-1289-9747
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 15

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs) by preferred term (PT)

  Percent(%)

  From baseline (week 0) to week 26

Secondary Outcomes (29)

• Number of adverse drug reaction (ADRs)

  From baseline (week 0) to week 26

• Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs)

  From baseline (week 0) to week 26

• Number of unexpected AEs and unexpected ADRs

  From baseline (week 0) to week 26

• Number of unexpected SAEs and unexpected SADRs

  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

  From baseline (week 0) to week 26

Study Arms (1)

Saxenda®

Patients with obesity treated with Saxenda® for weight management in routine clinical practice in Taiwan

Drug: Liraglutide

Interventions

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.

Also known as: Saxenda®

Saxenda®

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are patients with obesity treated with Saxenda® for weight management in routine clinical practice in Taiwan

You may qualify if:

• 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.
• Patients should have baseline (pre-dosing) values, including body height, weight and initial dosage of Saxenda® .
• 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.
• 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.

You may not qualify if:

• Known or suspected hypersensitivity to Saxenda® , the active substance or any of the excipients
• Previous participation in this study. Participation is defined as having given informed consent in this study.
• Treatment with any investigational drug within 30 days prior to initiation of Saxenda® treatment.
• Female patient who is pregnant, breast-feeding, or intends to become pregnant.
• Patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (15)

Changhua Christian Hospital_Metabolic Dept.

Changhua, 500, Taiwan

Location

Ditmanson Medical Foundation Chia-Yi Christian Hospital

Chiayi City, 600, Taiwan

Location

HsinChu MacKay Memorial Hospital

Hsinchu, 300, Taiwan

Location

HsinChu Municipal MacKay Children's Hospital

Hsinchu, 300, Taiwan

Location

Ton-Yen General Hospital

Hsinchu County, 302, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

TZ Clinic

Pingtung County, 900, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

Kuang Tien General Hospital

Taichung, 433, Taiwan

Location

Tungs Taichung MetroHarbor Hospital

Taichung, 435, Taiwan

Location

National Taiwan University Hospital

Taipei, 100229, Taiwan

Location

National Taiwan University Hospital_main

Taipei, 100, Taiwan

Location

Genesis Clinic

Taipei, 104, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: April 8, 2024
• Primary Completion: January 13, 2025
• Study Completion: January 13, 2025
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

TW (15)