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.
- Registration Number
- NCT03560336
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 758
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Overall Population Liraglutide Patients will be treated with commercially available liraglutide 3.0 mg according to routine clinical practice at the discretion of the treating physician
- Primary Outcome Measures
Name Time Method Incidence of adverse events (AEs) by preferred term (PT) From baseline to week 26 (± 3 weeks) Count of events
- Secondary Outcome Measures
Name Time Method Number of adverse drug reaction (ADRs) From baseline to week 26 (± 3 weeks) Count of events
Number of serious adverse events (SAEs) and serious adverse drug reations (SADRs) From baseline to week 26 (± 3 weeks) Count of events
Number of unexpected AEs and unexpected ADRs From baseline to week 26 (± 3 weeks) Count of events
Body weight loss (%) from week 0 to week 13 Week 0, week 13 Measured in percentage
Body weight loss (kg) from week 0 to week 26 Week 0, week 26 Measured in kg
The proportion of patients losing more than 10% of week 0 body weight at week 13 Week 0, week 13 Proportion of patients
The proportion of patients losing more than 10% of week 0 body weight at week 26 Week 0, week 26 Proportion of patients
The proportion of patients losing at least 5% of week 0 body weight at week 26 Week 0, week 26 Proportion of patients
Number of unexpected SAEs and unexpected SADRs From baseline to week 26 (± 3 weeks) Count of events
Dose of liraglutide after administration initiation week 26 (± 3 weeks) Measured in mg
Body weight loss (%) from week 0 to week 26 Week 0, week 26 Measured in percentage
Body weight loss (kg) from week 0 to week 13 Week 0, week 13 Measured in kg
The proportion of patients losing at least 5% of week 0 body weight at week 13 Week 0, week 13 Proportion of patients
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇰🇷Yangsan, Korea, Republic of