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

Obesity Clinical Trial

Official title:

Multicentre, Single-arm, Non-interventional Regulatory Post- Marketing Surveillance (rPMS) Study to Evaluate the Safety and Effectiveness of Saxenda® for Weight Management in Routine Clinical Practice in Taiwan.

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
• Start date: February 23, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• 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
• 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

Related Conditions & MeSH terms

• Obesity

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	National Taiwan University Hospital	Taipei City
Taiwan	National Taiwan University Hospital	Taipei 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