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

Obesity Clinical Trial

Official title:

A Multi-centre, Prospective, Non-interventional, Single-armed, 104 Weeks Post-marketing Study to Investigate Safety and Clinical Parameters of Wegovy® Once Weekly in Patients With Obesity Disease Under Real-world Clinical Practice Conditions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06283667
• Other study ID #: NN9536-4872
• Secondary ID: U1111-1266-3863
• Status: Not yet recruiting
• Start date: February 22, 2024
• Est. completion date: January 31, 2028

Study information

• Verified date: February 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: January 31, 2028
• Est. primary completion date: June 30, 2025
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Semaglutide
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.

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo	Chiyoda City

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Reactions (ARs)	Measured as count of events	From baseline (week 0) to end of study (week 104)
Secondary	Number of Adverse Events (AEs)	Measured as count of events	From baseline (week 0) to end of study (week 104)
Secondary	Number of serious adverse events (SAEs)	Measured as count of events	From baseline (week 0) to end of study (week 104)
Secondary	Number of Serious Adverse Reactions (SARs)	Measured as count of events	From baseline (week 0) to end of study (week 104)
Secondary	Change in body weight (Percent (%))	Measured as percent (%)	From baseline (week 0) to end of study (week 104)
Secondary	Change in body weight (Kilograms (Kg))	Measured in kilograms (Kg)	From baseline (week 0) to end of study (week 104)
Secondary	Change in waist circumference	Measured in centimeters (cm)	From baseline (week 0) to end of study (week 104)
Secondary	Change in BMI (Body Mass Index)	Measured in kilogram per meter square (kg/m^2)	From baseline (week 0) to end of study (week 104)
Secondary	Change in body weight after treatment discontinuation	Measured as percent (%)	From treatment discontinuation after at least 12 weeks to end of study (week 104)