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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
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.
Lead sponsor
Asset
Semaglutide
GLP-1 agonist
Listed sites
8
Recruiting sites
—
Enrollment
840
estimated
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 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.
Inclusion criteria
1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. 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.
3. 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.
Exclusion criteria
1. Participants who are or have previously been on semaglutide therapy before enrollment.
2. Known or suspected hypersensitivity to the active substance or any of the excipients of semaglutide.
3. Previous participation in this study. Participation is defined as having given informed consent in this study.
4. 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).
5. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Endpoints (14)
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
5 endpointsBody weight loss
Time frame:From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Body weight, % change
percent change from baseline, improvement
Body weight loss
Time frame:From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Body weight, absolute change (kg)
change from baseline, improvement
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)
≥5% weight-loss responders
threshold achievement, improvement
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)
≥10% weight-loss responders
threshold achievement, improvement
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)
≥15% weight-loss responders
threshold achievement, improvement
Safety / tolerability / PK
9 endpointsNumber (incidence) of AEs
Time frame:From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Treatment-emergent AEs (any)
event count, event
Number (incidence) of ADRs
Time frame:From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
event count, event
Number (incidence) of SAEs
Time frame:From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Serious AEs (any)
event count, event
Number (incidence) of SADRs
Time frame:From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
event count, event
Number (incidence) of unexpected AEs
Time frame:From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
event count, event
Number (incidence) of unexpected ADRs
Time frame:From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
event count, event
Number (incidence) of unexpected SAEs
Time frame:From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Serious AEs (any)
event count, event
Number (incidence) of unexpected SADRs
Time frame:From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
event count, event
Total dose of semaglutide
Time frame:From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
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.