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

Novo Nordisk

Status: Invitation-only

Conditions: Obesity

Treatments: Drug: Semaglutide

Study type: Observational

Funder types: Industry

Identifiers

NCT06283667

U1111-1266-3863 (Other Identifier)

NN9536-4872

Details and patient eligibility

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).

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

Wegovy®

Description:

Patients with obesity treated with Wegovy® (semaglutide) once weekly under real-world clinical practice conditions in Japan.

Treatment:

Drug: Semaglutide