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

• Conditions: Obesity and Overweight

• Registration Number: NCT07018544
• Lead Sponsor: Novo Nordisk A/S

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 available

Study Timeline

• Study Start: 2024-11-19
• Status Verified: 2025-06
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12
• Primary Completion: 2027-02-28
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 840

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The proportion of participants losing greater than or equal to 15% body weight	From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)	Percent (%)
Total dose of semaglutide	From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)	Milligram/milliliter (mg/mL)
The proportion of participants losing greater than or equal to 5% body weight	From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)	Percent (%)
The proportion of participants losing greater than or equal to 10% body weight	From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)	Percent (%)
Number (incidence) of ADRs	From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)	Count of events
Number (incidence) of SAEs	From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)	Count of events
Number (incidence) of SADRs	From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)	Count of events
Number (incidence) of unexpected ADRs	From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)	Count of events
Body weight loss	From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)	Kilogram (kg)
Number (incidence) of unexpected AEs	From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)	Count of events
Number (incidence) of unexpected SAEs	From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)	Count of events
Number (incidence) of unexpected SADRs	From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)	Count of events

Trial Locations

Locations (8)

MyongJi Hospital; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Busan, Korea, Republic of

Yonsei Hanaro Clinic; 🇰🇷 Chungcheongnam-do, Korea, Republic of

Daejeon Endo Internal Medicine Clinic; 🇰🇷 Daejeon, Korea, Republic of

Ajou University Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Hplus Yangji Hospital; 🇰🇷 Seoul, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Korea, Republic of