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

Novo Nordisk

Status: Completed

Conditions: Obesity

Treatments: Drug: Liraglutide

Study type: Observational

Funder types: Industry

Identifiers

NCT06283641

U1111-1289-9747 (Other Identifier)

NN8022-7780

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Saxenda®

Description:

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

Treatment:

Drug: Liraglutide