A Multicentre, Prospective, Single-arm, Non-interventiona... | NCT07018544

Studies
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

NCT07018544

Sponsor

Novo Nordisk A/S

Status

Enrolling by invitation

Last Update Posted

Jun 12, 2025Actual

Enrollment

840Estimated

Phase

Not provided

Conditions

Obesity and Overweight

Interventions

semaglutide

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
U1111-1281-9419	Other Identifier	WHO

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 19, 2024Actual

Primary Completion Date

Feb 28, 2027Estimated

Completion Date

Feb 28, 2027Estimated

First Submitted Date

Jun 4, 2025

First Submission Date that Met QC Criteria

Jun 4, 2025

First Posted Date

Jun 12, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2025

Last Update Posted Date

Jun 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. This study will last for about 4 years and participants will participate in the study for approximately 26 weeks.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

840Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Other: semaglutide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
semaglutide	Other	Participants will be treated with commercially available semaglutide according to routine clinical practice at the discretion of the treating physician.	Semaglutide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number (incidence) of AEs	Count of events	From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Number (incidence) of ADRs	Count of events	From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Number (incidence) of SAEs	Count of events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
MyongJi Hospital		Goyang-si	Gyeonggi-do	10475	South Korea
Kosin University Gospel Hospital

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D009765	Obesity
D050177	Overweight