Clinical trial 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.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Overweight
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-06-18
Enrollment: 758
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese patients and overweight patients with obesity-related comorbidities

Brief 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.


Eligibility 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

Primary outcomes:
measure: Incidence of adverse events (AEs) by preferred term (PT)
timeFrame: From baseline to week 13 (± 3 weeks)
measure: Incidence of adverse events (AEs) by preferred term (PT)
timeFrame: From baseline to week 26 (± 3 weeks)
Secondary outcomes:
measure: Number of adverse drug reaction (ADRs)
timeFrame: From baseline to week 13 (± 3 weeks)
measure: Number of adverse drug reaction (ADRs)
timeFrame: From baseline to week 26 (± 3 weeks)
measure: Number of serious adverse events (SAEs) and serious adverse drug reations (SADRs)
timeFrame: From baseline to week 13 (± 3 weeks)
measure: Number of serious adverse events (SAEs) and serious adverse drug reations (SADRs)
timeFrame: From baseline to week 26 (± 3 weeks)
measure: Number of unexpected AEs and unexpected ADRs
timeFrame: From baseline to week 13 (± 3 weeks)
measure: Number of unexpected AEs and unexpected ADRs
timeFrame: From baseline to week 26 (± 3 weeks)
measure: Number of unexpected SAEs and unexpected SADRs
timeFrame: From baseline to week 13 (± 3 weeks)
measure: Number of unexpected SAEs and unexpected SADRs
timeFrame: From baseline to week 26 (± 3 weeks)
measure: Dose of liraglutide after administration initiation
timeFrame: week 13 (± 3 weeks)
measure: Dose of liraglutide after administration initiation
timeFrame: week 26 (± 3 weeks)
measure: Body weight loss (%) from week 0 to week 13
timeFrame: Week 0, week 13
measure: Body weight loss (%) from week 0 to week 26
timeFrame: Week 0, week 26
measure: Body weight loss (kg) from week 0 to week 13
timeFrame: Week 0, week 13
measure: Body weight loss (kg) from week 0 to week 26
timeFrame: Week 0, week 26
measure: The proportion of patients losing at least 5% of week 0 body weight at week 13
timeFrame: Week 0, week 13
measure: The proportion of patients losing at least 5% of week 0 body weight at week 26
timeFrame: Week 0, week 26
measure: The proportion of patients losing more than 10% of week 0 body weight at week 13
timeFrame: Week 0, week 13
measure: The proportion of patients losing more than 10% of week 0 body weight at week 26
timeFrame: Week 0, week 26
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Busan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Busan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Busan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Busan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Busan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Daegu
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Gangwon-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Gwangju
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Incheon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seongnam-si
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Suwon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Yangsan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References: