Obesity and OverweightNCT07018544
A Multicentre, Prospective, Single-arm, Non-interventional Regulatory Post-marketing Surveillance (rPMS) Study to Investigate the Safety and Effectiveness of Wegovy® (Semaglutide) in Patients With Obesity and Patients With Overweight in Routine Clinical Practice in Korea
An observational study of Obesity and Overweight, run by Novo Nordisk A/S at 8 sites in South Korea.
Trial summary
This study is conducted to investigate the safety and effectiveness of semaglutide in participants with obesity and overweight in routine clinical practice. Participants will get semaglutide as prescribed by a doctor. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- semaglutide
- How many people
- 840 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 19 Nov 2024to 28 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- Adult, Older adult
Study population: Participants will be treated with commercially available semaglutide according to the approved label and to real-world clinical practice at the discretion of the treating physician. The decision to treat participants with semaglutide has been made by the treating physician independently from the decision to include the participants in this study.
Who may be able to join
- Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- The decision to initiate treatment with commercially available semaglutide has been made by the participants and the treating physician before and independently from the decision to include the participant in this study.
- Male or female adults, age above or equal to 19 years who is scheduled to start treatment with semaglutide based on the clinical judgment of their treating physician as specified in the Korean-prescribing Information (approved label in Korea) at the time of signing informed consent.
Who cannot join
- Participants who are or have previously been on semaglutide therapy before enrollment.
- Known or suspected hypersensitivity to the active substance or any of the excipients of semaglutide.
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Female participant who is pregnant, breast-feeding, or intends to become pregnant and is of childbearing potential not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice).
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
South Korea8 sites
Kosin University Gospel Hospital
Busan, 49267
Yonsei Hanaro Clinic
Chungcheongnam-do, 31019
Daejeon Endo Internal Medicine Clinic
Daejeon, 35220
MyongJi Hospital
Goyang-si, Gyeonggi-do, 10475
Ajou University Hospital
Gyeonggi-do, 16499
Samsung Medical Center
Seoul, 06351
Hplus Yangji Hospital
Seoul, 08779
Pusan National University Yangsan Hospital
Yangsan, 50612
About this study
Official title: A Multicentre, Prospective, Single-arm, Non-interventional Regulatory Post-marketing Surveillance (rPMS) Study to Investigate the Safety and Effectiveness of Wegovy® (Semaglutide) in Patients With Obesity and Patients With Overweight in Routine Clinical Practice in Korea.
This study is conducted to investigate the safety and effectiveness of semaglutide in participants with obesity and overweight in routine clinical practice. Participants will get semaglutide as prescribed by a doctor. This study will last for about 4 years and participants will participate in the study for approximately 26 weeks.
- Conditions
- Obesity and Overweight
- Being tested
- semaglutide
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutideOther
Also called Wegovy
Participants will be treated with commercially available semaglutide according to routine clinical practice at the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Participants will be treated with commercially available semaglutide according to the approved label and to real-world clinical practice at the discretion of the treating physician. The decision to treat participants with semaglutide has been made by the treating physician independently from the decision to include the participants in this study. Receives: Other: semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (incidence) of AEs
Count of events
Measured: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Secondary outcomes (13)
Number (incidence) of ADRs
Count of events
Measured: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Number (incidence) of SAEs
Count of events
Measured: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Number (incidence) of SADRs
Count of events
Measured: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Number (incidence) of unexpected AEs
Count of events
Measured: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Number (incidence) of unexpected ADRs
Count of events
Measured: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Number (incidence) of unexpected SAEs
Count of events
Measured: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Number (incidence) of unexpected SADRs
Count of events
Measured: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Total dose of semaglutide
Milligram/milliliter (mg/mL)
Measured: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Body weight loss
Percent (%)
Measured: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Body weight loss
Kilogram (kg)
Measured: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
The proportion of participants losing greater than or equal to 5% body weight
Percent (%)
Measured: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
The proportion of participants losing greater than or equal to 10% body weight
Percent (%)
Measured: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
The proportion of participants losing greater than or equal to 15% body weight
Percent (%)
Measured: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start19 Nov 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 840 participants (estimated)
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
- NCT07018544
- Sponsor's protocol ID
- NN9536-7543
- Other IDs
- U1111-1281-9419
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Prospective, Single-arm, Non-interventional Regulatory Post-marketing Surveillance (rPMS) Study to Investigate the Safety and Effectiveness of Wegovy® (Semaglutide) in Patients With Obesity and Patients With Overweight in Routine Clinical Practice in Korea.
- ClinicalTrials.gov ID
- NCT07018544
- Acronym / sponsor ID
- NN9536-7543
- Conditions
- Obesity and Overweight
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 12 Jun 2025 (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 study is conducted to investigate the safety and effectiveness of semaglutide in participants with obesity and overweight in routine clinical practice. Participants will get semaglutide as prescribed by a doctor. This study will last for about 4 years and participants will participate in the study for approximately 26 weeks.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | – | Other: semaglutideParticipants will be treated with commercially available semaglutide according to the approved label and to real-world clinical practice at the discretion of the treating physician. The decision to treat participants with semaglutide has been made by the treating physician independently from the decision to include the participants in this study. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants will be treated with commercially available semaglutide according to the approved label and to real-world clinical practice at the discretion of the treating physician. The decision to treat participants with semaglutide has been made by the treating physician independently from the decision to include the participants in this study.
Key inclusion criteria (3 listed)
- Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- The decision to initiate treatment with commercially available semaglutide has been made by the participants and the treating physician before and independently from the decision to include the participant in this study.
- Male or female adults, age above or equal to 19 years who is scheduled to start treatment with semaglutide based on the clinical judgment of their treating physician as specified in the Korean-prescribing Information (approved label in Korea) at the time of signing informed consent.
Key exclusion criteria (5 listed)
- Participants who are or have previously been on semaglutide therapy before enrollment.
- Known or suspected hypersensitivity to the active substance or any of the excipients of semaglutide.
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Female participant who is pregnant, breast-feeding, or intends to become pregnant and is of childbearing potential not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice).
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
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 |
|---|---|---|
| semaglutideAlso: WegovyParticipants will be treated with commercially available semaglutide according to routine clinical practice at the discretion of the treating physician. | Other | Semaglutide |
Primary outcome
Number (incidence) of AEs
Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Count of events
13 secondary outcomes
Number (incidence) of ADRs
Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Number (incidence) of SAEs
Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Number (incidence) of SADRs
Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Number (incidence) of unexpected AEs
Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Number (incidence) of unexpected ADRs
Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Number (incidence) of unexpected SAEs
Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Number (incidence) of unexpected SADRs
Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Total dose of semaglutide
Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Body weight loss
Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Body weight loss
Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
The proportion of participants losing greater than or equal to 5% body weight
Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
The proportion of participants losing greater than or equal to 10% body weight
Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
The proportion of participants losing greater than or equal to 15% body weight
Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- 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.
Clinical Transparency dept. 2834 study director
Novo Nordisk A/S
8 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 and Overweight, run by Novo Nordisk A/S at 8 sites in South Korea.
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 3 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number (incidence) of AEs (time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)). 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 12 Jun 2025.