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Special Use - Results Surveillance on Long-term Use With Wegovy® | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATION

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

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

NCT06283667•Novo Nordisk A/S

View on ClinicalTrials.gov

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).

Eligibility

Age

All ages

Sex

ALL

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

Locations (112)

Novo Nordisk Investigational Site

Tokyo, Chiyoda City, Japan

Jinnouchi Hospital_Internal Medicine

Kumamoto, Kumamoto, Japan, Japan

Okazaki City Hospital

Aichi, Japan

Nagoya City University Hospital_Obesity Treatment Center

Aichi, Japan

Fujita Health University Hospital_Endocrinology, Diabetes and Metabolism

Aichi, Japan

Ichinomiyanishi Hospital

Aichi, Japan

Nakadori General Hospital_Diabetes and Endocrinology

Akita, Japan

Odate Municipal General Hospital_Endocrinology and Metabolism

Akita, Japan

Akita University Hospital, Diabetes and Endocrinology

Akita-shi, Akita, Japan

Hachinohe City Hospital_Diabetes and Metabolism

Aomori, Japan

Key Dates

Start Date

June 11, 2024

Primary Completion Date

January 31, 2028

Completion Date

January 31, 2028

Last Updated

October 29, 2025

Enrollment

1,000

ESTIMATED participants

Conditions

Obesity

Interventions

Semaglutide

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

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