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Active (not recruiting) NCT06283667

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

Conditions: Obesity

Sponsor: Novo Nordisk A/S

trial.available_in: БГ
Overview
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).
Who can participate
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
Interventions
Semaglutide
DRUG
Locations 112
Unknown (1)
Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology
Japan (111)
Okazaki City Hospital
Aichi
Nagoya City University Hospital_Obesity Treatment Center
Aichi
Fujita Health University Hospital_Endocrinology, Diabetes and Metabolism
Aichi
Ichinomiyanishi Hospital
Aichi
Nakadori General Hospital_Diabetes and Endocrinology
Akita
Odate Municipal General Hospital_Endocrinology and Metabolism
Akita
Akita University Hospital, Diabetes and Endocrinology
Akita-shi, Akita
Hachinohe City Hospital_Diabetes and Metabolism
Aomori
Juntendo University Hospital_Tokyo
Bunkyo-ku, Tokyo
Shinmatsudo Central General Hospital_Diabetes and Endocrinology
Chiba
Toho University Sakura Medical Center
Chiba
Kimitsu Chuo Hospital_Diabetology and Endocrinology
Chiba
Kameda Medical Center_Diabetes and Endocrinology
Chiba
Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus
Chikushino-shi, Fukuoka
Chiba University Hospital_Diabetes, Metabolism and Endocrinology
Chiyoda-ku, Tokyo
Mikannohana Clinic
Ehime
Matsuyama Shimin Hospital_Diabetes and Endocrinology
Ehime
University of Fukui Hospital
Fukui
National Hospital Organization Fukuokahigashi Medical Center_Diabetes and Endocrinology
Fukuoka
Fukuoka Kieikai Hospital_Diabetes and obesity centre
Fukuoka
Fukuoka Sanno Hospital_Diabetology and Endocrinology and Metabolism
Fukuoka
Kyushu University Hospital_Endocrine Metab Diab inter med
Fukuoka-shi, Fukuoka
Fukushima Medical University Hospital_Diabetes and Endocrinology
Fukushima
Chuno Kosei Hospital_Endocrinology and Diabetes
Gifu
Matsunami General Hospital_Diabetes and Endocrinology
Gifu
Ogaki Municipal Hospital_Diabetes and Nephrology
Gifu
Gunma University Hospital_Endocrinology and Diabetes
Gunma
Hamamatsu University Hospital_Liver Internal Medicine
Hamamatsu-shi, Shizuoka
Murakami Memorial Hospital_Diabetes Internal Medicine
Hiroshima
Mazda Hospital_Diabetes
Hiroshima
Sapporo Tonyobyo Kojosen Clinic
Hokkaido
Japanese Red Cross Asahikawa Hospital_Diabetes and Endocrinology
Hokkaido
Hyogo Medical University Hospital_Diabetes, Endocrinology and Metabolism
Hyōgo
University of Tsukuba Hospital_Diabetes and Endocrinology
Ibaraki
Shimane Univ. HP, Dept of Endocrinology&Metabolism
Izumo, Shimane
Kagoshima University Hospital_Diabetes and Endocrinology
Kagoshima
Kawasaki Municipal Hospital_Diabetes and Endocrinology
Kanagawa
Kanto Rousai Hospital_Diabetes and Endocrinology
Kanagawa
St. Marianna University School of Medicine Hospital
Kanagawa
Yokohama Rosai Hospital_Diabetes and Endocrinology
Kanagawa
Showa University Fujigaoka Hospital_Internal Medicine
Kanagawa
Yokohama City Minato Red Cross Hospital_Endocrinology
Kanagawa
Yokohama City University Medical Center_Endocrinology and Diabetes
Kanagawa
Tokai University Hospital_Nephrology, Endocrinology and Metabolism
Kanagawa
Yokohama City University Medical Center_Nephrology and Hypertension
Kanahawa
Kasugai Municipal Hospital_Cardiovascular Medicine
Kasugai-shi, Aichi
Nippon Medical School Musashikosugi Hospital_Neurological Surgery
Kawasaki-shi, Kanagawa-ken
Kochi Medical School Hospital_Endocrinology, Metabolism and Nephrology
Kochi
Jinnouchi Hospital_Internal Medicine
Kumamoto , Kumamoto, Japan
Kumamoto General Hospital_Diabetes Center
Kumamoto
Minamata City General Hospital & Medical Center_Metabolism
Kumamoto
Kumamoto University Hospital, Diabetes, Metabo and Endo
Kumamoto-shi, Kumamoto
Kure Medical Center and Chugoku Cancer Center
Kure-shi, Hiroshima
Shin Koga Hospital
Kurume-shi, Fukuoka
University Hospital Kyoto Prefectual University of Medicine
Kyoto
Kyoto City Hospital_Diabetes and Metabolism
Kyoto
Kyoto University Hospital_Department of Diabetes, Endocr
Kyoto-shi, Kyoto
National Hospital Organization Kyoto Medical Center_Cardiology
Kyoto-shi, Kyoto
Mie University Hospital_Diabetes and Endocrinology
Mie
Japanese Red Cross Ise Hospital_Diabetes and Metabolism
Mie
Miura Central Clinic
Miura-shi, Kanagawa
Aichi Medical University Hospital_Diabetes Medicine
Nagakute-shi, Aichi
Nagano Matsushiro General Hospital_department of diet
Nagano
University of the Ryukyus Hospital
Nakagami-gun, Okinawa-ken
Iwate Medical University Uchimaru Medical Center, Division of Diabetes and Metabolism and Endocrine medicine
Numakunai
Shinbeppu Hospital_Endocrinology and Metabolism
Ōita
Okayama University Hospital_Neph. and Diabetes, Metabolism
Okayama
Okayama Rosai Hospital_Cardiology
Okayama
Okayama Medical Center_Cardiology
Okayama-shi, Okayama
Urasoe General Hospital_Cardiology
Okinawa
Osaka National Hospital_Diabetes Internal Medicine
Osaka
Osaka Metropolitan University Hospital_Lifestyle disease diabetes centre
Osaka
Chibune Hospital_Diabetes and Endocrinology
Osaka
Matsushita Memorial Hospital_Diabetes and Endocrinology
Osaka
Kishiwada City Hospital_Endocrinology and Metabolism
Osaka
Bellland Sogo Byoin_Endocrinology and Metabolism
Osaka
Osaka City General Hospital_Endocrinology and Diabetes Mellitus
Osaka-shi, Osaka
Osaki citizen hospital_Diabetes and metabolic disease
Osaki-shi, Miyagi
Karatsu Redcross Hospital_Diabetes Internal Medicine
Saga
Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism Endocrinology
Sapporo-shi, Hokkaido
NTT East Japan Sapporo HP_Diabetes Mellitus & Int med Endo
Sapporo, Hokkaido
Aso Clinic
Shizuoka
Juntendo University Shizuoka Hospital_Diabetes and Endocrinology
Shizuoka
JA Shizuoka Kohseiren Enshu Hospital_Internal Medicine
Shizuoka
Hamamatsu Medical Center_Endocrinology and Metabolism
Shizuoka
Japanese Red Cross Hamamatsu Hospital_Cardiology
Shizuoka
Chutoen General Medical Center_Diabetes and Endocrinology
Shizuoka
Nagasaki Hospital_Internal Medicine
Tochigi
Sano Kosei General Hospital_Neph.& Endocrinology,Metab.
Tochigi
Tamaki Aozora Byoin_Diabetes and Endocrinology
Tokushima
Gifu University Hospital_The Third Dept. of Internal Medicine
Tokyo
Nihon University Hospital_Internal Medicine
Tokyo
Tokyo Teishin Hospital
Tokyo
Nihonbashi Leiwa Naika Clinic
Tokyo
The Jikei University Hospital Dept of Diabetes, Metabolic
Tokyo
Institute of Science Tokyo Hospital_Cardiology
Tokyo
National Center for Child Health and Development_Internal medicine for women
Tokyo
Keio University Hospital_Neurology
Tokyo
Tokyo Women's Medical University_Diabetes and Metabolism
Tokyo
Kyorin University Hospital_Diabetes and Endocrinology
Tokyo
Tokyo Metropolitan Tama Medical Center
Tokyo
Novo Nordisk Investigational Site
Tokyo , Chiyoda City
Tottori University Hospital_Endocrinology and Metabolism
Tottori
Tottori University Hospital_Pharmacotherapy
Tottori
Toyohashi Municipal Hospital
Toyohashi-shi, Aichi-ken
Japanese Red Cross Wakayama Medical Center_Diabetology and Endocrinology
Wakayama
Wakayama Medical Univercity Hospital_Diabetes and Endocrinology
Wakayama
Yamagata University Hospital, Internal Medicine 3
Yamagata-shi, Yamagata
Shimonoseki Medical Center_Diabetes and Endocrinology
Yamaguchi
Yamaguchi Rosai Hospital_Diabetes and Endocrinology
Yamaguchi
Yokohama City University Hospital_Endocrinology, Metabolism
Yokohama, Kanagawa
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Healthy volunteers
No
Start date
11.06.2024
Completion date
31.01.2028
Registry ID
NCT06283667
Source
clinicaltrials.gov
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