A Regulatory Post-marketing Surveillance (rPMS) Study to Evaluate the Safety and Effectiveness of Saxenda®(Liraglutide 3.0 mg) in Obese Patients and Overweight Patients With Obesity-related Comorbidities in Routine Clinical Practice in Korea.

Novo Nordisk

Status: Completed

Conditions: Overweight; Obesity

Treatments: Drug: Liraglutide

Study type: Observational

Funder types: Industry

Identifiers

NCT03560336

NN8022-4380

U111-1199-8606 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to collect information about the safety and effectiveness of Saxenda® in obese patients and overweight patients with obesity-related comorbidities. The participant will attend the clinic or hospital according to usual practice and receive medical care, as agreed with the study doctor. The participation is expected to be approximately for 26 weeks.

Enrollment: 758 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: - The decision to initiate treatment with commercially available Saxenda® has been made by the patient/Legally Acceptable Representative (LAR) and the physician before and independently from the decision to include the patient in this study - Informed consent obtained before any study-related activities Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study - Male or Female of Native Korean, age greater than or equal to 18 years who is scheduled to start treatment with Saxenda® based on the clinical judgment of physician as specified in the Korean-Prescribing Information (local label) Exclusion Criteria: - Patients who are or have previously been on Saxenda® therapy - 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 enrolment into the study - Female patient who is pregnant, breast-feeding, or intends to become pregnant and is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by Korea regulation or practice) - Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation

Trial design

758 participants in 1 patient group

Overall Population

Description:

Patients will be treated with commercially available liraglutide 3.0 mg according to routine clinical practice at the discretion of the treating physician

Treatment:

Drug: Liraglutide