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Study to Evaluate the Safety and Effectiveness of Saxenda® for Weight Management in Routine Clinical Practice in Taiwan.
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.
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
15
Recruiting sites
—
Enrollment
300
actual
Study population
Obesity / overweight
Key I/E criterion
—
Primary endpoint
•Treatment-emergent AEs (any)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Study population text
Participants are patients with obesity treated with Saxenda® for weight management in routine clinical practice in Taiwan
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
Endpoints (30)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
24 endpointsBody weight loss Percent (%) (Adult)
Time frame:From baseline (week 0) to week 13
Body weight, % change
percent change from baseline, improvement
Body weight loss (%) (Adult)
Time frame:From baseline (week 0) to week 26
Body weight, % change
percent change from baseline, improvement
Body weight loss Kilogram(Kg) (Adult)
Time frame:From baseline (week 0) to week 13
Body weight, absolute change (kg)
change from baseline, improvement
Body weight loss (kg) (Adult)
Time frame:From baseline (week 0) to week 26
Body weight, absolute change (kg)
change from baseline, improvement
The proportion of adult subjects losing at least 5% of baseline body weight
Time frame:At Week 13
≥5% weight-loss responders
threshold achievement, improvement
The proportion of adult subjects losing at least 5% of baseline body weight
Time frame:At Week 26
≥5% weight-loss responders
threshold achievement, improvement
The proportion of adult subjects losing more than 10% of baseline body weight
Time frame:At Week 13
≥10% weight-loss responders
threshold achievement, improvement
The proportion of adult subjects losing more than 10% of baseline body weight
Time frame:At Week 26
≥10% weight-loss responders
threshold achievement, improvement
The proportion of losing at least 5% of baseline body weight from adult subjects whose maintenance dose of 3 mg, 12- week Saxenda®
Time frame:At Week 26
≥5% weight-loss responders
threshold achievement, improvement
Change in body mass index (BMI) (kg/m^2) (Adolescent)
Time frame:From baseline (week 0) to week 13
BMI, change
change from baseline, improvement
Change in body mass index (BMI) (kg/m^2) (Adolescent)
Time frame:From baseline (week 0) to week 26
BMI, change
change from baseline, improvement
Change in body mass index (BMI) (%) (Adolescent)
Time frame:From baseline (week 0) to week 13
BMI, change
percent change from baseline, improvement
Change in body mass index (BMI) (%) (Adolescent)
Time frame:From baseline (week 0) to week 26
percent change from baseline, improvement
Change in body mass index standard deviation score (BMI SDS) (Adolescent)
Time frame:From baseline (week 0) to week 13
BMI SDS, change
change from baseline, improvement
Change in body mass index standard deviation score (BMI SDS) (Adolescent)
Time frame:From baseline (week 0) to week 26
BMI SDS, change
change from baseline, improvement
Body weight loss (%) (Adolescent)
Time frame:From baseline (week 0) to week 13
Body weight, % change
percent change from baseline, improvement
Body weight loss (%) (Adolescent)
Time frame:From baseline (week 0) to week 26
Body weight, % change
percent change from baseline, improvement
Body weight loss (kg) (Adolescent)
Time frame:From baseline (week 0) to week 13
Body weight, absolute change (kg)
change from baseline, improvement
Body weight loss (kg) (Adolescent)
Time frame:From baseline (week 0) to week 26
Body weight, absolute change (kg)
change from baseline, improvement
The proportion of adolescent subjects losing at least 4% of baseline BMI
Time frame:At Week 13
threshold achievement, improvement
The proportion of adolescent subjects losing at least 4% of baseline BMI
Time frame:At Week 26
threshold achievement, improvement
The proportion of adolescent subjects losing at least 10% of baseline BMI
Time frame:At Week 13
≥10% weight-loss responders
threshold achievement, improvement
The proportion of adolescent subjects losing at least 10% of baseline BMI
Time frame:At Week 26
≥10% weight-loss responders
threshold achievement, improvement
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®
Time frame:At Week 26
threshold achievement, improvement
Safety / tolerability / PK
6 endpointsIncidence of adverse events (AEs) by preferred term (PT)
Time frame:From baseline (week 0) to week 26
Treatment-emergent AEs (any)
event count, event
Number of adverse drug reaction (ADRs)
Time frame:From baseline (week 0) to week 26
event count, event
Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs)
Time frame:From baseline (week 0) to week 26
Serious AEs (any)
event count, event
componentsSerious AEs (any)
Number of unexpected AEs and unexpected ADRs
Time frame:From baseline (week 0) to week 26
event count, event
componentsTreatment-emergent AEs (any)
Number of unexpected SAEs and unexpected SADRs
Time frame:From baseline (week 0) to week 26
Serious AEs (any)
event count, event
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
Time frame:From baseline (week 0) to week 26
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.