Study to Evaluate the Safety and Effectiveness of Saxenda® for Weight Management in Routine Clinical Practice in Taiwan.

Novo Nordisk A/S300 enrolled

Overview

This is a non-interventional study to evaluate the safety and effectiveness of Saxenda® in obese adults and adolescents in Taiwan. The participants will recieve Saxenda® treatment which is a medicine that doctors can already prescribe. The study will last for about 26 weeks.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Obesity

Interventions

LiraglutideDRUG

Participants will be treated with commercially available Saxenda® according to routine clinical practice at the discretion of the treating physician, following approved label in Taiwan. The decision to initiate treatment with commercially available Saxenda® has been made by the patient and the treating physician before and independently from the decision to participate in this study.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or Female of Taiwanese patients, age above or equal to 12 years who are under Saxenda® treatment or are scheduled to treat with Saxenda® according to approved label in Taiwan based on the clinical judgment of their treating physician. 2. Patients should have baseline (pre-dosing) values, including body height, weight and initial dosage of Saxenda® . 3. The decision to initiate treatment or to have started with commercially available Saxenda® has been made by the patient/Legally Acceptable Representative (LAR) and the physician independently from the decision to join this study. 4. Informed consent obtained before collection of clinical data for this study. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. Exclusion Criteria: 1. Known or suspected hypersensitivity to Saxenda® , the active substance or any of the excipients 2. Previous participation in this study. Participation is defined as having given informed consent in this study. 3. Treatment with any investigational drug within 30 days prior to initiation of Saxenda® treatment. 4. Female patient who is pregnant, breast-feeding, or intends to become pregnant. 5. Patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). 6. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation

Locations (15)

Changhua Christian Hospital_Metabolic Dept.

Changhua, Taiwan

Ditmanson Medical Foundation Chia-Yi Christian Hospital

Chiayi City, Taiwan

HsinChu MacKay Memorial Hospital

Hsinchu, Taiwan

Outcomes

Primary Outcomes

Incidence of adverse events (AEs) by preferred term (PT)

Percent(%)

Time frame: From baseline (week 0) to week 26

Secondary Outcomes

Number of adverse drug reaction (ADRs)

Number of events

Time frame: From baseline (week 0) to week 26

Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs)

Number of events

Time frame: From baseline (week 0) to week 26

Number of unexpected AEs and unexpected ADRs

Number of events

Time frame: From baseline (week 0) to week 26

Number of unexpected SAEs and unexpected SADRs

Number of events

Time frame: From baseline (week 0) to week 26

Dose and exposure of liraglutide after initiation and reasons if not escalate to liraglutide 3.0 miligram (mg) for maintenance as specified in the product label

Milligram(mg)

Time frame: From baseline (week 0) to week 26

Body weight loss Percent (%) (Adult)

Percent (%)

Time frame: From baseline (week 0) to week 13

Body weight loss (%) (Adult)

Percent (%)

Time frame: From baseline (week 0) to week 26

Body weight loss Kilogram(Kg) (Adult)

Data from ClinicalTrials.gov

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HsinChu Municipal MacKay Children's Hospital

Hsinchu, Taiwan

Ton-Yen General Hospital

Hsinchu County, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

TZ Clinic

Pingtung County, Taiwan

China Medical University Hospital

Taichung, Taiwan

Kuang Tien General Hospital

Taichung, Taiwan

Tungs Taichung MetroHarbor Hospital

Taichung, Taiwan

...and 5 more locations

Time frame: From baseline (week 0) to week 13

Body weight loss (kg) (Adult)

Kilogram(Kg)

Time frame: From baseline (week 0) to week 26

The proportion of adult subjects losing at least 5% of baseline body weight

Percent (%)

Time frame: At Week 13

The proportion of adult subjects losing at least 5% of baseline body weight

Percent (%)

Time frame: At Week 26

The proportion of adult subjects losing more than 10% of baseline body weight

Percent (%)

Time frame: At Week 13

The proportion of adult subjects losing more than 10% of baseline body weight

Percent (%)

Time frame: At Week 26

The proportion of losing at least 5% of baseline body weight from adult subjects whose maintenance dose of 3 mg, 12- week Saxenda®

Percent (%)

Time frame: At Week 26

Change in body mass index (BMI) (kg/m^2) (Adolescent)

Kilogram(Kg) divided by meters squared(m2)

Time frame: From baseline (week 0) to week 13

Change in body mass index (BMI) (kg/m^2) (Adolescent)

Kilogram(Kg) divided by meters squared(m2)

Time frame: From baseline (week 0) to week 26

Change in body mass index (BMI) (%) (Adolescent)

Percent (%)

Time frame: From baseline (week 0) to week 13

Change in body mass index (BMI) (%) (Adolescent)

Percent (%)

Time frame: From baseline (week 0) to week 26

Change in body mass index standard deviation score (BMI SDS) (Adolescent)

Change in body mass index standard deviation score (BMI SDS)

Time frame: From baseline (week 0) to week 13

Change in body mass index standard deviation score (BMI SDS) (Adolescent)

Change in body mass index standard deviation(BMI SDS)

Time frame: From baseline (week 0) to week 26

Body weight loss (%) (Adolescent)

Percent (%)

Time frame: From baseline (week 0) to week 13

Body weight loss (%) (Adolescent)

Percent (%)

Time frame: From baseline (week 0) to week 26

Body weight loss (kg) (Adolescent)

Kilogram(Kg)

Time frame: From baseline (week 0) to week 13

Body weight loss (kg) (Adolescent)

Kilogram(Kg)

Time frame: From baseline (week 0) to week 26

The proportion of adolescent subjects losing at least 4% of baseline BMI

Percent(%)

Time frame: At Week 13

The proportion of adolescent subjects losing at least 4% of baseline BMI

Percent(%)

Time frame: At Week 26

The proportion of adolescent subjects losing at least 10% of baseline BMI

Percent(%)

Time frame: At Week 13

The proportion of adolescent subjects losing at least 10% of baseline BMI

Percent(%)

Time frame: At Week 26

The proportion of losing at least 4% of baseline BMI from adolescent subjects whose maintenance dose of 3 mg or maximum tolerated dose, 12- week Saxenda®

Percent(%)

Time frame: At Week 26