NCT03560336

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.

Prospective, Multicentre, Open-label, Single-arm, Non-interventional 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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 758 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Obesity
• Overweight

Interventions

Type	Name	Description
DRUG	Liraglutide	Patients will initiate treatment with liraglutide according to the approved label in Korea. Patients will initiate 0.6 mg daily and weekly increase the dose by 0.6 mg until reaching 3.0 mg daily. Patients will then continue to stay on 3.0 mg/day (total treatment duration: 26 weeks).

Timeline

• Start date: 2018-07-05
• Primary completion: 2020-12-02
• Completion: 2020-12-02
• First posted: 2018-06-18
• Last updated: 2021-07-09

Locations

28 sites across 1 country: South Korea