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 | Enrolling By Invitation DMC

• 2 other identifiers: NN9536-7543U1111-1281-9419
• Study Type: observational
• Target: 840
• Locations: 1 country
• Sites: 8

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.

Conditions

Obesity and Overweight

Outcome Measures

Primary Outcomes (1)

• Number (incidence) of AEs

  Count of events

  From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)

Secondary Outcomes (13)

• Number (incidence) of ADRs

  From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)

• Number (incidence) of SAEs

  From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)

• Number (incidence) of SADRs

  From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)

• Number (incidence) of unexpected AEs

  From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)

• Number (incidence) of unexpected ADRs

  From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)

Study Arms (1)

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

semaglutide OTHER

Participants will be treated with commercially available semaglutide according to routine clinical practice at the discretion of the treating physician.

Also known as: Wegovy

Semaglutide

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (8)

MyongJi Hospital

Goyang-si, Gyeonggi-do, 10475, South Korea

Location

Kosin University Gospel Hospital

Busan, 49267, South Korea

Location

Yonsei Hanaro Clinic

Chungcheongnam-do, 31019, South Korea

Location

Daejeon Endo Internal Medicine Clinic

Daejeon, 35220, South Korea

Location

Ajou University Hospital

Gyeonggi-do, 16499, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hplus Yangji Hospital

Seoul, 08779, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: November 19, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

KR (8)