ObesityNCT06283641
Study to Evaluate the Safety and Effectiveness of Saxenda® for Weight Management in Routine Clinical Practice in Taiwan.
An observational study of Obesity, run by Novo Nordisk A/S at 15 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Liraglutide
- How many people
- 300 participants
- Where
- 15 sitesTaiwan
- Study dates
- 8 Apr 2024to 13 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Child, Adult, Older adult
Study population: Participants are patients with obesity treated with Saxenda® for weight management in routine clinical practice in Taiwan
Who may be able to join
- 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.
- Patients should have baseline (pre-dosing) values, including body height, weight and initial dosage of Saxenda® .
- 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.
- 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.
Who cannot join
- Known or suspected hypersensitivity to Saxenda® , the active substance or any of the excipients
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Treatment with any investigational drug within 30 days prior to initiation of Saxenda® treatment.
- Female patient who is pregnant, breast-feeding, or intends to become pregnant.
- Patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Taiwan15 sites
Changhua Christian Hospital_Metabolic Dept.
Changhua, 500
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City, 600
HsinChu MacKay Memorial Hospital
Hsinchu, 300
HsinChu Municipal MacKay Children's Hospital
Hsinchu, 300
Ton-Yen General Hospital
Hsinchu County, 302
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
TZ Clinic
Pingtung County, 900
China Medical University Hospital
Taichung, 404
Kuang Tien General Hospital
Taichung, 433
Tungs Taichung MetroHarbor Hospital
Taichung, 435
National Taiwan University Hospital
Taipei, 100229
National Taiwan University Hospital_main
Taipei, 100
Genesis Clinic
Taipei, 104
Taipei Medical University Hospital
Taipei, 110
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333
About this study
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.
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.
- Conditions
- Obesity
- Being tested
- Liraglutide
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Saxenda®
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.
| Study group | Role | What they receive |
|---|---|---|
| Saxenda® | Patients with obesity treated with Saxenda® for weight management in routine clinical practice in Taiwan Receives: Drug: Liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) by preferred term (PT)
Percent(%)
Measured: From baseline (week 0) to week 26
Secondary outcomes (29)
Number of adverse drug reaction (ADRs)
Number of events
Measured: From baseline (week 0) to week 26
Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs)
Number of events
Measured: From baseline (week 0) to week 26
Number of unexpected AEs and unexpected ADRs
Number of events
Measured: From baseline (week 0) to week 26
Number of unexpected SAEs and unexpected SADRs
Number of events
Measured: 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)
Measured: From baseline (week 0) to week 26
Body weight loss Percent (%) (Adult)
Percent (%)
Measured: From baseline (week 0) to week 13
Body weight loss (%) (Adult)
Percent (%)
Measured: From baseline (week 0) to week 26
Body weight loss Kilogram(Kg) (Adult)
Kilogram(Kg)
Measured: From baseline (week 0) to week 13
Body weight loss (kg) (Adult)
Kilogram(Kg)
Measured: From baseline (week 0) to week 26
The proportion of adult subjects losing at least 5% of baseline body weight
Percent (%)
Measured: At Week 13
The proportion of adult subjects losing at least 5% of baseline body weight
Percent (%)
Measured: At Week 26
The proportion of adult subjects losing more than 10% of baseline body weight
Percent (%)
Measured: At Week 13
The proportion of adult subjects losing more than 10% of baseline body weight
Percent (%)
Measured: 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 (%)
Measured: At Week 26
Change in body mass index (BMI) (kg/m^2) (Adolescent)
Kilogram(Kg) divided by meters squared(m2)
Measured: From baseline (week 0) to week 13
Change in body mass index (BMI) (kg/m^2) (Adolescent)
Kilogram(Kg) divided by meters squared(m2)
Measured: From baseline (week 0) to week 26
Change in body mass index (BMI) (%) (Adolescent)
Percent (%)
Measured: From baseline (week 0) to week 13
Change in body mass index (BMI) (%) (Adolescent)
Percent (%)
Measured: 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)
Measured: 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)
Measured: From baseline (week 0) to week 26
Body weight loss (%) (Adolescent)
Percent (%)
Measured: From baseline (week 0) to week 13
Body weight loss (%) (Adolescent)
Percent (%)
Measured: From baseline (week 0) to week 26
Body weight loss (kg) (Adolescent)
Kilogram(Kg)
Measured: From baseline (week 0) to week 13
Body weight loss (kg) (Adolescent)
Kilogram(Kg)
Measured: From baseline (week 0) to week 26
The proportion of adolescent subjects losing at least 4% of baseline BMI
Percent(%)
Measured: At Week 13
The proportion of adolescent subjects losing at least 4% of baseline BMI
Percent(%)
Measured: At Week 26
The proportion of adolescent subjects losing at least 10% of baseline BMI
Percent(%)
Measured: At Week 13
The proportion of adolescent subjects losing at least 10% of baseline BMI
Percent(%)
Measured: 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(%)
Measured: At Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start8 Apr 2024
- Primary completion13 Jan 2025
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283641
- Sponsor's protocol ID
- NN8022-7780
- Other IDs
- U1111-1289-9747
- Status last verified
- Jan 2026
- First submitted
- 21 Feb 2024
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06283641
- Acronym / sponsor ID
- NN8022-7780
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Saxenda® | – | Drug: LiraglutidePatients with obesity treated with Saxenda® for weight management in routine clinical practice in Taiwan |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Participants are patients with obesity treated with Saxenda® for weight management in routine clinical practice in Taiwan
Key inclusion criteria (4 listed)
- 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.
- Patients should have baseline (pre-dosing) values, including body height, weight and initial dosage of Saxenda® .
- 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.
- 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.
Key exclusion criteria (6 listed)
- Known or suspected hypersensitivity to Saxenda® , the active substance or any of the excipients
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Treatment with any investigational drug within 30 days prior to initiation of Saxenda® treatment.
- Female patient who is pregnant, breast-feeding, or intends to become pregnant.
- Patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideAlso: Saxenda®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. | Drug | Saxenda® |
Primary outcome
Incidence of adverse events (AEs) by preferred term (PT)
Time frame: From baseline (week 0) to week 26
Percent(%)
29 secondary outcomes
Number of adverse drug reaction (ADRs)
Time frame: From baseline (week 0) to week 26
Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs)
Time frame: From baseline (week 0) to week 26
Number of unexpected AEs and unexpected ADRs
Time frame: From baseline (week 0) to week 26
Number of unexpected SAEs and unexpected SADRs
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
Time frame: From baseline (week 0) to week 26
Body weight loss Percent (%) (Adult)
Time frame: From baseline (week 0) to week 13
Body weight loss (%) (Adult)
Time frame: From baseline (week 0) to week 26
Body weight loss Kilogram(Kg) (Adult)
Time frame: From baseline (week 0) to week 13
Body weight loss (kg) (Adult)
Time frame: From baseline (week 0) to week 26
The proportion of adult subjects losing at least 5% of baseline body weight
Time frame: At Week 13
The proportion of adult subjects losing at least 5% of baseline body weight
Time frame: At Week 26
The proportion of adult subjects losing more than 10% of baseline body weight
Time frame: At Week 13
The proportion of adult subjects losing more than 10% of baseline body weight
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®
Time frame: At Week 26
Change in body mass index (BMI) (kg/m^2) (Adolescent)
Time frame: From baseline (week 0) to week 13
Change in body mass index (BMI) (kg/m^2) (Adolescent)
Time frame: From baseline (week 0) to week 26
Change in body mass index (BMI) (%) (Adolescent)
Time frame: From baseline (week 0) to week 13
Change in body mass index (BMI) (%) (Adolescent)
Time frame: From baseline (week 0) to week 26
Change in body mass index standard deviation score (BMI SDS) (Adolescent)
Time frame: From baseline (week 0) to week 13
Change in body mass index standard deviation score (BMI SDS) (Adolescent)
Time frame: From baseline (week 0) to week 26
Body weight loss (%) (Adolescent)
Time frame: From baseline (week 0) to week 13
Body weight loss (%) (Adolescent)
Time frame: From baseline (week 0) to week 26
Body weight loss (kg) (Adolescent)
Time frame: From baseline (week 0) to week 13
Body weight loss (kg) (Adolescent)
Time frame: From baseline (week 0) to week 26
The proportion of adolescent subjects losing at least 4% of baseline BMI
Time frame: At Week 13
The proportion of adolescent subjects losing at least 4% of baseline BMI
Time frame: At Week 26
The proportion of adolescent subjects losing at least 10% of baseline BMI
Time frame: At Week 13
The proportion of adolescent subjects losing at least 10% of baseline BMI
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®
Time frame: At Week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Novo Nordisk A/S at 15 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) by preferred term (PT) (time frame: From baseline (week 0) to week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.