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

Launched by NOVO NORDISK A/S · Feb 21, 2024

Keywords

ClinConnect Summary

This is a long-term, real-world study in Japan looking at safety and how Wegovy® (semaglutide) works for people with obesity when used in everyday medical care. It plans to enroll about 1,000 people who start Wegovy as prescribed by their doctor and follow each person for about two years (104 weeks). The study will mainly track safety by counting any adverse reactions from the start to the end of the study, and it will also look at other safety events plus changes in weight, waist size, and BMI. It is an observational, single-armed study (no random assignment or separate control group), and ongoing in real medical settings across many sites.

Eligible participants include both men and women of any age who have obesity and at least one related health issue such as high blood pressure, abnormal cholesterol, or type 2 diabetes, with BMI criteria of either ≥27 kg/m2 plus two or more obesity-related conditions or BMI ≥35 kg/m2. Key requirements include giving informed consent and having a doctor decide to start Wegovy before or at the time of joining the study. The dosing and care will follow standard clinical practice in Japan, not a fixed study protocol. Sponsored by Novo Nordisk, the study collects data in real-world settings to better understand Wegovy’s safety and how it affects weight and related health measures over time.

Gender

ALL

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 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