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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06283641
Other study ID # NN8022-7780
Secondary ID U1111-1289-9747
Status Enrolling by invitation
Phase
First received
Last updated
Start date February 23, 2024
Est. completion date February 28, 2025

Study information

Verified date May 2024
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 288
Est. completion date February 28, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers
Gender All
Age group 12 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Liraglutide
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.

Locations

Country Name City State
Taiwan Changhua Christian Hospital Changhua City
Taiwan Ditmanson Medical Foundation Chia-Yi Christian Hospital Chiayi City
Taiwan HsinChu MacKay Memorial Hospital Hsinchu City
Taiwan HsinChu Municipal MacKay Children's Hospital Hsinchu City
Taiwan Ton-Yen General Hospital Hsinchu County
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan TZ Clinic Pingtung County
Taiwan China Medical University Hospital Taichung
Taiwan Kuang Tien General Hospital Taichung City
Taiwan Tungs Taichung MetroHarbor Hospital Taichung city
Taiwan Genesis Clinic Taipei City
Taiwan National Taiwan University Hospital Taipei City
Taiwan National Taiwan University Hospital Taipei City
Taiwan Taipei Medical University Hospital Taipei city
Taiwan Chang Gung Memorial Hospital Linkou Taoyuan City

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events (AEs) by preferred term (PT) Percent(%) From baseline (week 0) to week 26
Secondary Number of adverse drug reaction (ADRs) Number of events From baseline (week 0) to week 26
Secondary Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs) Number of events From baseline (week 0) to week 26
Secondary Number of unexpected AEs and unexpected ADRs Number of events From baseline (week 0) to week 26
Secondary Number of unexpected SAEs and unexpected SADRs Number of events From baseline (week 0) to week 26
Secondary 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) From baseline (week 0) to week 26
Secondary Body weight loss Percent (%) (Adult) Percent (%) From baseline (week 0) to week 13
Secondary Body weight loss (%) (Adult) Percent (%) From baseline (week 0) to week 26
Secondary Body weight loss Kilogram(Kg) (Adult) Kilogram(Kg) From baseline (week 0) to week 13
Secondary Body weight loss (kg) (Adult) Kilogram(Kg) From baseline (week 0) to week 26
Secondary The proportion of adult subjects losing at least 5% of baseline body weight Percent (%) At Week 13
Secondary The proportion of adult subjects losing at least 5% of baseline body weight Percent (%) At Week 26
Secondary The proportion of adult subjects losing more than 10% of baseline body weight Percent (%) At Week 13
Secondary The proportion of adult subjects losing more than 10% of baseline body weight Percent (%) At Week 26
Secondary The proportion of losing at least 5% of baseline body weight from adult subjects whose maintenance dose of 3 mg, 12- week Saxenda® Percent (%) At Week 26
Secondary Change in body mass index (BMI) (kg/m^2) (Adolescent) Kilogram(Kg) divided by meters squared(m2) From baseline (week 0) to week 13
Secondary Change in body mass index (BMI) (kg/m^2) (Adolescent) Kilogram(Kg) divided by meters squared(m2) From baseline (week 0) to week 26
Secondary Change in body mass index (BMI) (%) (Adolescent) Percent (%) From baseline (week 0) to week 13
Secondary Change in body mass index (BMI) (%) (Adolescent) Percent (%) From baseline (week 0) to week 26
Secondary Change in body mass index standard deviation score (BMI SDS) (Adolescent) Change in body mass index standard deviation score (BMI SDS) From baseline (week 0) to week 13
Secondary Change in body mass index standard deviation score (BMI SDS) (Adolescent) Change in body mass index standard deviation(BMI SDS) From baseline (week 0) to week 26
Secondary Body weight loss (%) (Adolescent) Percent (%) From baseline (week 0) to week 13
Secondary Body weight loss (%) (Adolescent) Percent (%) From baseline (week 0) to week 26
Secondary Body weight loss (kg) (Adolescent) Kilogram(Kg) From baseline (week 0) to week 13
Secondary Body weight loss (kg) (Adolescent) Kilogram(Kg) From baseline (week 0) to week 26
Secondary The proportion of adolescent subjects losing at least 4% of baseline BMI Percent(%) At Week 13
Secondary The proportion of adolescent subjects losing at least 4% of baseline BMI Percent(%) At Week 26
Secondary The proportion of adolescent subjects losing at least 10% of baseline BMI Percent(%) At Week 13
Secondary The proportion of adolescent subjects losing at least 10% of baseline BMI Percent(%) At Week 26
Secondary 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(%) At Week 26
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