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

Novo Nordisk

Status: Invitation-only

Conditions: Obesity and Overweight

Treatments: Other: semaglutide

Study type: Observational

Funder types: Industry

Identifiers

NCT07018544

NN9536-7543

U1111-1281-9419 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 840 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

840 participants in 1 patient group

Semaglutide

Description:

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.

Treatment:

Other: semaglutide