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.

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03560336
• Other study ID #: NN8022-4380
• Secondary ID: U111-1199-8606
• Status: Completed
• Start date: July 5, 2018
• Est. completion date: December 2, 2020

Study information

• Verified date: July 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 758
• Est. completion date: December 2, 2020
• Est. primary completion date: December 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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).

Locations

Country	Name	City	State
Korea, Republic of	Novo Nordisk Investigational Site	Busan
Korea, Republic of	Novo Nordisk Investigational Site	Busan
Korea, Republic of	Novo Nordisk Investigational Site	Busan
Korea, Republic of	Novo Nordisk Investigational Site	Busan
Korea, Republic of	Novo Nordisk Investigational Site	Busan
Korea, Republic of	Novo Nordisk Investigational Site	Busan
Korea, Republic of	Novo Nordisk Investigational Site	Daegu
Korea, Republic of	Novo Nordisk Investigational Site	Daejeon
Korea, Republic of	Novo Nordisk Investigational Site	Daejeon
Korea, Republic of	Novo Nordisk Investigational Site	Gangwon-do
Korea, Republic of	Novo Nordisk Investigational Site	Gwangju
Korea, Republic of	Novo Nordisk Investigational Site	Gyeonggi-do
Korea, Republic of	Novo Nordisk Investigational Site	Gyeonggi-do
Korea, Republic of	Novo Nordisk Investigational Site	Gyeonggi-do
Korea, Republic of	Novo Nordisk Investigational Site	Gyeonggi-do
Korea, Republic of	Novo Nordisk Investigational Site	Incheon
Korea, Republic of	Novo Nordisk Investigational Site	Seongnam-si
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Suwon
Korea, Republic of	Novo Nordisk Investigational Site	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs) by preferred term (PT)	Count of events	From baseline to week 13 (± 3 weeks)
Primary	Incidence of adverse events (AEs) by preferred term (PT)	Count of events	From baseline to week 26 (± 3 weeks)
Secondary	Number of adverse drug reaction (ADRs)	Count of events	From baseline to week 13 (± 3 weeks)
Secondary	Number of adverse drug reaction (ADRs)	Count of events	From baseline to week 26 (± 3 weeks)
Secondary	Number of serious adverse events (SAEs) and serious adverse drug reations (SADRs)	Count of events	From baseline to week 13 (± 3 weeks)
Secondary	Number of serious adverse events (SAEs) and serious adverse drug reations (SADRs)	Count of events	From baseline to week 26 (± 3 weeks)
Secondary	Number of unexpected AEs and unexpected ADRs	Count of events	From baseline to week 13 (± 3 weeks)
Secondary	Number of unexpected AEs and unexpected ADRs	Count of events	From baseline to week 26 (± 3 weeks)
Secondary	Number of unexpected SAEs and unexpected SADRs	Count of events	From baseline to week 13 (± 3 weeks)
Secondary	Number of unexpected SAEs and unexpected SADRs	Count of events	From baseline to week 26 (± 3 weeks)
Secondary	Dose of liraglutide after administration initiation	Measured in mg	week 13 (± 3 weeks)
Secondary	Dose of liraglutide after administration initiation	Measured in mg	week 26 (± 3 weeks)
Secondary	Body weight loss (%) from week 0 to week 13	Measured in percentage	Week 0, week 13
Secondary	Body weight loss (%) from week 0 to week 26	Measured in percentage	Week 0, week 26
Secondary	Body weight loss (kg) from week 0 to week 13	Measured in kg	Week 0, week 13
Secondary	Body weight loss (kg) from week 0 to week 26	Measured in kg	Week 0, week 26
Secondary	The proportion of patients losing at least 5% of week 0 body weight at week 13	Proportion of patients	Week 0, week 13
Secondary	The proportion of patients losing at least 5% of week 0 body weight at week 26	Proportion of patients	Week 0, week 26
Secondary	The proportion of patients losing more than 10% of week 0 body weight at week 13	Proportion of patients	Week 0, week 13
Secondary	The proportion of patients losing more than 10% of week 0 body weight at week 26	Proportion of patients	Week 0, week 26