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Enrolling by invitation NCT07018544

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

— Observational Obesity and Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: semaglutide.
Who it may be relevant to
Registry conditions: Obesity and Overweight. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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.

Interventions

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

Primary outcome measures

  • Number (incidence) of AEs [Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
Secondary outcome measures (12)
  • Number (incidence) of ADRs [Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • Number (incidence) of SAEs [Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • Number (incidence) of SADRs [Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • Number (incidence) of unexpected AEs [Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • Number (incidence) of unexpected ADRs [Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • Number (incidence) of unexpected SAEs [Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • Number (incidence) of unexpected SADRs [Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • Total dose of semaglutide [Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • Body weight loss [Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • Body weight loss [Time frame: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)]
  • 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)]
  • 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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

South Korea · 8 centers
  • MyongJi Hospital — Goyang-si
  • Kosin University Gospel Hospital — Busan
  • Yonsei Hanaro Clinic — Chungcheongnam-do
  • Daejeon Endo Internal Medicine Clinic — Daejeon
  • Ajou University Hospital — Gyeonggi-do
  • Samsung Medical Center — Seoul
  • Hplus Yangji Hospital — Seoul
  • Pusan National University Yangsan Hospital — Yangsan

Identifiers

NCT: NCT07018544 · NN9536-7543 · U1111-1281-9419

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗