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Active, not recruiting Observational

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

NCT06283667 · tracked via the Priya Life Science Japan tracker
Phase
Observational
Started
2024-06-11
Last updated
2026-04-22

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

Semaglutide →

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.

Study 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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of Adverse Reactions (ARs) — From baseline (week 0) to end of study (week 104)
    Measured as count of events

Trial sites (112)

FacilityCityRegionStatus
Novo Nordisk Investigational Site Tokyo Chiyoda City
Jinnouchi Hospital_Internal Medicine Kumamoto Kumamoto, 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
Juntendo University Hospital_Tokyo Bunkyo-ku, Tokyo Japan
Shinmatsudo Central General Hospital_Diabetes and Endocrinology Chiba Japan
Toho University Sakura Medical Center Chiba Japan
Kimitsu Chuo Hospital_Diabetology and Endocrinology Chiba Japan
Kameda Medical Center_Diabetes and Endocrinology Chiba Japan
Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus Chikushino-shi, Fukuoka Japan
Chiba University Hospital_Diabetes, Metabolism and Endocrinology Chiyoda-ku, Tokyo Japan
Mikannohana Clinic Ehime Japan
Matsuyama Shimin Hospital_Diabetes and Endocrinology Ehime Japan
University of Fukui Hospital Fukui Japan
National Hospital Organization Fukuokahigashi Medical Center_Diabetes and Endocrinology Fukuoka Japan
Fukuoka Kieikai Hospital_Diabetes and obesity centre Fukuoka Japan
Fukuoka Sanno Hospital_Diabetology and Endocrinology and Metabolism Fukuoka Japan
Kyushu University Hospital_Endocrine Metab Diab inter med Fukuoka-shi, Fukuoka Japan
Fukushima Medical University Hospital_Diabetes and Endocrinology Fukushima Japan
Chuno Kosei Hospital_Endocrinology and Diabetes Gifu Japan
Matsunami General Hospital_Diabetes and Endocrinology Gifu Japan
Ogaki Municipal Hospital_Diabetes and Nephrology Gifu Japan
Gunma University Hospital_Endocrinology and Diabetes Gunma Japan
Hamamatsu University Hospital_Liver Internal Medicine Hamamatsu-shi, Shizuoka Japan
Murakami Memorial Hospital_Diabetes Internal Medicine Hiroshima Japan
Mazda Hospital_Diabetes Hiroshima Japan
Sapporo Tonyobyo Kojosen Clinic Hokkaido Japan
Japanese Red Cross Asahikawa Hospital_Diabetes and Endocrinology Hokkaido Japan
Hyogo Medical University Hospital_Diabetes, Endocrinology and Metabolism Hyōgo Japan
University of Tsukuba Hospital_Diabetes and Endocrinology Ibaraki Japan
Shimane Univ. HP, Dept of Endocrinology&Metabolism Izumo, Shimane Japan
Kagoshima University Hospital_Diabetes and Endocrinology Kagoshima Japan
Kawasaki Municipal Hospital_Diabetes and Endocrinology Kanagawa Japan
Kanto Rousai Hospital_Diabetes and Endocrinology Kanagawa Japan

+ 72 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06283667 on ClinicalTrials.gov ↗ ← All trials in Japan