Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06283667

Active, not recruitingNot applicableObservational

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

AgeNot listed to Not listed

SexAll

Healthy volunteersNot listed

ConditionObesity

Full registry 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 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

Treatments and study arms

Semaglutide

Drug

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.

Primary outcomes

Number of Adverse Reactions (ARs)From baseline (week 0) to end of study (week 104)

Measured as count of events

Study locations

112 locations were listed when this page was built. The first 40 are shown.

Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology🌐 Location details pending