Special Use - Results Surveillance on Long-term Use With Wegovy®

N/AActive Not RecruitingNCT06283667

Novo Nordisk A/S1,071 enrolled

Overview

The purpose of the study is to investigate the safety and effectiveness of Wegovy® in patients with obesity disease under real-world clinical practice in Japan. Participants will get Wegovy® as prescribed by the study doctor. The study will last for about 4 years. Participant will be in the study for about 2 years (104 weeks).

Study Type

OBSERVATIONAL

Enrollment

1,071

Conditions

Obesity

Interventions

SemaglutideDRUG

Paricipants will be treated with commercially available Wegovy® according to routine clinical practice at the discretion of the treating physician, following approved label in Japan. The decision to initiate treatment with commercially available Wegovy® has been made by the patient and the treating physician before and independently from the decision to participate in this study.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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 Wegovy® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study * Male or female, no age limitation * Diagnosis of obesity disease; with either hypertension, dyslipidaemia or type 2 diabetes, insufficiently controlled with diet and exercise therapies, and should meet either of: 1. Body mass index (BMI)\* greater than or equal to 27 kilograms per meter square (kg/m\^2) with two or more obesity-related comorbidities\*\*, or 2. BMI\* greater than or equal to 35 kg/m\^2 * Participant who has never been exposed to Semaglutide or who started treatment with Wegovy® within the past 4 weeks at registration * BMI calculation will be based on height and body weight recorded in the enrolment form of electronic case report form (eCRF) at enrolment. * Definition of obesity-related comorbidities are in accordance with Japan Student Services Organization (JASSO) guideline 3: (1) impaired glucose tolerance, (2) dyslipidaemia, (3) hypertension, (4) hyper-uricemia/gout, (5) coronary artery disease, (6) cerebral infarction, (7) non-alcoholic fatty liver disease, (8) menstrual disorder/infertility, (9) obstructive sleep apnoea syndrome/obesity-hypoventilation syndrome, (10) locomotory disease or (11) obesity-related kidney disease. Exclusion Criteria: * Previous participation in this study. Participation is defined as having given informed consent in this study * Treatment with any investigational drug within 30 days prior to baseline (Visit 1) * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * A history of hypersensitivity to any ingredients of this drug * Diabetic ketoacidosis, diabetic coma, pre-coma or type 1 diabetes mellitus \[The treatment with insulin is mandatory. It is not appropriate to use this drug\] * In emergency cases such as severe infections and surgery in patients with type 2 diabetes \[It is desirable to control blood glucose with insulin; therefore, administration of this drug is not appropriate\] * Pregnant or possibly pregnant female * Female who plans to become pregnant within 2 months

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