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.

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Drug: Liraglutide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Overall Population<br>Patients will be treated with commercially available liraglutide 3.0 mg according to routine clinical practice at the discretion of the treating physician | Drug: Liraglutide<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) by preferred term (PT) | Count of events | From baseline to week 13 (± 3 weeks) | 
| Incidence of adverse events (AEs) by preferred term (PT) | Count of events | From baseline to week 26 (± 3 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse drug reaction (ADRs) | Count of events | From baseline to week 13 (± 3 weeks) | 
| Number of adverse drug reaction (ADRs) | Count of events | From baseline to week 26 (± 3 weeks) | 
| Number of serious adverse events (SAEs) and serious adverse drug reations (SADRs) | Count of events | From baseline to week 13 (± 3 weeks) | 
| Number of serious adverse events (SAEs) and serious adverse drug reations (SADRs) | Count of events | From baseline to week 26 (± 3 weeks) | 
| Number of unexpected AEs and unexpected ADRs | Count of events | From baseline to week 13 (± 3 weeks) | 
| Number of unexpected AEs and unexpected ADRs | Count of events | From baseline to week 26 (± 3 weeks) | 
| Number of unexpected SAEs and unexpected SADRs | Count of events | From baseline to week 13 (± 3 weeks) | 
| Number of unexpected SAEs and unexpected SADRs | Count of events | From baseline to week 26 (± 3 weeks) | 
| Dose of liraglutide after administration initiation | Measured in mg | week 13 (± 3 weeks) | 
| Dose of liraglutide after administration initiation | Measured in mg | week 26 (± 3 weeks) | 
| Body weight loss (%) from week 0 to week 13 | Measured in percentage | Week 0, week 13 | 
| Body weight loss (%) from week 0 to week 26 | Measured in percentage | Week 0, week 26 | 
| Body weight loss (kg) from week 0 to week 13 | Measured in kg | Week 0, week 13 | 
| Body weight loss (kg) from week 0 to week 26 | Measured in kg | Week 0, week 26 | 
| The proportion of patients losing at least 5% of week 0 body weight at week 13 | Proportion of patients | Week 0, week 13 | 
| The proportion of patients losing at least 5% of week 0 body weight at week 26 | Proportion of patients | Week 0, week 26 | 
| The proportion of patients losing more than 10% of week 0 body weight at week 13 | Proportion of patients | Week 0, week 13 | 
| The proportion of patients losing more than 10% of week 0 body weight at week 26 | Proportion of patients | Week 0, week 26 |