Clinical trial NCT06283641: Study to Evaluate the Safety and Effectiveness of Saxenda® for Weight Management in Routine Clinical Practice in Taiwan.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are patients with obesity treated with Saxenda® for weight management in routine clinical practice in Taiwan

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events (AEs) by preferred term (PT)
timeFrame: From baseline (week 0) to week 26
Secondary outcomes:
measure: Number of adverse drug reaction (ADRs)
timeFrame: From baseline (week 0) to week 26
measure: Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs)
timeFrame: From baseline (week 0) to week 26
measure: Number of unexpected AEs and unexpected ADRs
timeFrame: From baseline (week 0) to week 26
measure: Number of unexpected SAEs and unexpected SADRs
timeFrame: From baseline (week 0) to week 26
measure: 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
timeFrame: From baseline (week 0) to week 26
measure: Body weight loss Percent (%) (Adult)
timeFrame: From baseline (week 0) to week 13
measure: Body weight loss (%) (Adult)
timeFrame: From baseline (week 0) to week 26
measure: Body weight loss Kilogram(Kg) (Adult)
timeFrame: From baseline (week 0) to week 13
measure: Body weight loss (kg) (Adult)
timeFrame: From baseline (week 0) to week 26
measure: The proportion of adult subjects losing at least 5% of baseline body weight
timeFrame: At Week 13
measure: The proportion of adult subjects losing at least 5% of baseline body weight
timeFrame: At Week 26
measure: The proportion of adult subjects losing more than 10% of baseline body weight
timeFrame: At Week 13
measure: The proportion of adult subjects losing more than 10% of baseline body weight
timeFrame: At Week 26
measure: The proportion of losing at least 5% of baseline body weight from adult subjects whose maintenance dose of 3 mg, 12- week Saxenda®
timeFrame: At Week 26
measure: Change in body mass index (BMI) (kg/m^2) (Adolescent)
timeFrame: From baseline (week 0) to week 13
measure: Change in body mass index (BMI) (kg/m^2) (Adolescent)
timeFrame: From baseline (week 0) to week 26
measure: Change in body mass index (BMI) (%) (Adolescent)
timeFrame: From baseline (week 0) to week 13
measure: Change in body mass index (BMI) (%) (Adolescent)
timeFrame: From baseline (week 0) to week 26
measure: Change in body mass index standard deviation score (BMI SDS) (Adolescent)
timeFrame: From baseline (week 0) to week 13
measure: Change in body mass index standard deviation score (BMI SDS) (Adolescent)
timeFrame: From baseline (week 0) to week 26
measure: Body weight loss (%) (Adolescent)
timeFrame: From baseline (week 0) to week 13
measure: Body weight loss (%) (Adolescent)
timeFrame: From baseline (week 0) to week 26
measure: Body weight loss (kg) (Adolescent)
timeFrame: From baseline (week 0) to week 13
measure: Body weight loss (kg) (Adolescent)
timeFrame: From baseline (week 0) to week 26
measure: The proportion of adolescent subjects losing at least 4% of baseline BMI
timeFrame: At Week 13
measure: The proportion of adolescent subjects losing at least 4% of baseline BMI
timeFrame: At Week 26
measure: The proportion of adolescent subjects losing at least 10% of baseline BMI
timeFrame: At Week 13
measure: The proportion of adolescent subjects losing at least 10% of baseline BMI
timeFrame: At Week 26
measure: 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®
timeFrame: At Week 26
Other outcomes:
Locations:
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital
city: Chiayi City
country: Taiwan
facility: Ditmanson Medical Foundation Chia-Yi Christian Hospital
city: Hsinchu City
country: Taiwan
facility: HsinChu MacKay Memorial Hospital
city: Hsinchu City
country: Taiwan
facility: HsinChu Municipal MacKay Children's Hospital
city: Hsinchu County
country: Taiwan
facility: Ton-Yen General Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Pingtung County
country: Taiwan
facility: TZ Clinic
city: Taichung City
country: Taiwan
facility: Kuang Tien General Hospital
city: Taichung city
country: Taiwan
facility: Tungs Taichung MetroHarbor Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei City
country: Taiwan
facility: Genesis Clinic
city: Taipei city
country: Taiwan
facility: Taipei Medical University Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital Linkou
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: