Special Use - Results Surveillance on Long-term Use With Wegovy®
- Conditions
- Obesity
- Interventions
- Registration Number
- NCT06283667
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1000
-
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:
- 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
- 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.
-
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Wegovy® Semaglutide Patients with obesity treated with Wegovy® (semaglutide) once weekly under real-world clinical practice conditions in Japan.
- Primary Outcome Measures
Name Time Method Number of Adverse Reactions (ARs) From baseline (week 0) to end of study (week 104) Measured as count of events
- Secondary Outcome Measures
Name Time Method Change in BMI (Body Mass Index) From baseline (week 0) to end of study (week 104) Measured in kilogram per meter square (kg/m\^2)
Change in body weight after treatment discontinuation From treatment discontinuation after at least 12 weeks to end of study (week 104) Measured as percent (%)
Number of Serious Adverse Reactions (SARs) From baseline (week 0) to end of study (week 104) Measured as count of events
Number of serious adverse events (SAEs) From baseline (week 0) to end of study (week 104) Measured as count of events
Change in body weight (Percent (%)) From baseline (week 0) to end of study (week 104) Measured as percent (%)
Change in body weight (Kilograms (Kg)) From baseline (week 0) to end of study (week 104) Measured in kilograms (Kg)
Change in waist circumference From baseline (week 0) to end of study (week 104) Measured in centimeters (cm)
Number of Adverse Events (AEs) From baseline (week 0) to end of study (week 104) Measured as count of events
Trial Locations
- Locations (110)
JA Shizuoka Kohseiren Enshu Hospital_Internal Medicine
🇯🇵Shizuoka, Japan
Nagoya City University Hospital_Obesity Treatment Center
🇯🇵Aichi, Japan
Kameda Medical Center_Diabetes and Endocrinology
🇯🇵Chiba, Japan
Minamata City General Hospital & Medical Center
🇯🇵Kumamoto, Japan
Shin Koga Hospital
🇯🇵Kurume-shi, Fukuoka, Japan
University of the Ryukyus Hospital
🇯🇵Nakagami-gun, Okinawa-ken, Japan
Osaka City General Hospital_Endocrinology and Diabetes Mellitus
🇯🇵Osaka-shi, Osaka, Japan
Osaka National Hospital_Osaka
🇯🇵Osaka, Japan
Osaka Metropolitan University Hospital_Lifestyle disease diabetes centre
🇯🇵Osaka, Japan
Matsushita Memorial Hospital
🇯🇵Osaka, Japan
Mikannohana Clinic
🇯🇵Ehime, Japan
Murakami Memorial Hospital
🇯🇵Hiroshima, Japan
Yokohama City Minato Red Cross Hospital
🇯🇵Kanagawa, Japan
Kure Medical Center and Chugoku Cancer Center
🇯🇵Kure-shi, Hiroshima, Japan
Mie University Hospital_Mie
🇯🇵Mie, Japan
Ichinomiyanishi Hospital
🇯🇵Aichi, Japan
Odate Municipal General Hospital
🇯🇵Akita, Japan
National Hospital Organization Fukuokahigashi Medical Center
🇯🇵Fukuoka, Japan
Showa University Fujigaoka Hospital_Internal Medicine
🇯🇵Kanagawa, Japan
University Hospital Kyoto Prefectual University of Medicine
🇯🇵Kyoto, Japan
Jinnouchi Hospital
🇯🇵Kumamoto-shi, Kumamoto, Japan, Japan
Akita University Hospital, Diabetes and Endocrinology
🇯🇵Akita-shi, Akita, Japan
Hamamatsu University Hospital
🇯🇵Hamamatsu-shi, Shizuoka, Japan
Mazda Hospital
🇯🇵Hiroshima, Japan
Fukuoka Kieikai Hospital_Diabetes and obesity centre
🇯🇵Fukuoka, Japan
Yokohama City University Medical Center_Nephrology and Hypertension
🇯🇵Kanahawa, Japan
Chuno Kosei Hospital_Endocrinology and Diabetes
🇯🇵Gifu, Japan
Kagoshima University Hospital_Diabetes and Endocrinology
🇯🇵Kagoshima, Japan
Kumamoto General Hospital_Diabetes Center
🇯🇵Kumamoto, Japan
Aichi Medical University Hospital, Diabetes Medicine
🇯🇵Nagakute-shi, Aichi, Japan
Fujita Health University Hospital_Endocrinology, Diabetes and Metabolism
🇯🇵Aichi, Japan
Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus
🇯🇵Chikushino-shi, Fukuoka, Japan
University of Fukui Hospital
🇯🇵Fukui, Japan
Japanese Red Cross Ise Hospital
🇯🇵Mie, Japan
Kishiwada City Hospital_Endocrinology and Metabolism
🇯🇵Osaka, Japan
Bellland Sogo Byoin
🇯🇵Osaka, Japan
Juntendo University Shizuoka Hospital_Diabetes and Endocrinology
🇯🇵Shizuoka, Japan
Hamamatsu Medical Center
🇯🇵Shizuoka, Japan
Chutoen General Medical Center_Diabetes and Endocrinology
🇯🇵Shizuoka, Japan
Nagasaki Hospital
🇯🇵Tochigi, Japan
Tamaki Aozora Byoin
🇯🇵Tokushima, Japan
Institute of Science Tokyo Hospital_Cardiology
🇯🇵Tokyo, Japan
National Center for Child Health and Development_Internal medicine for women
🇯🇵Tokyo, Japan
Toyohashi Municipal Hospital
🇯🇵Toyohashi-shi, Aichi-ken, Japan
Yamaguchi Rosai Hospital
🇯🇵Yamaguchi, Japan
Yokohama City University Hospital, Endocrinology, Metabolism
🇯🇵Yokohama, Kanagawa, Japan
Novo Nordisk Investigational Site
🇯🇵Tokyo, Chiyoda City, Japan
Chiba University Hospital_Diabetes, Metabolism and Endocrinology
🇯🇵Chiyoda-ku, Tokyo, Japan
Matsunami General Hospital
🇯🇵Gifu, Japan
Hyogo Medical University Hospital_Diabetes, Endocrinology and Metabolism
🇯🇵Hyogo, Japan
Okazaki City Hospital
🇯🇵Aichi, Japan
Nakadori General Hospital_Diabetes and Endocrinology
🇯🇵Akita, Japan
Hachinohe City Hospital_Diabetes and Metabolism
🇯🇵Aomori, Japan
Juntendo University Hospital_Tokyo
🇯🇵Bunkyo-ku, Tokyo, Japan
Toho University Medical Center Sakura Hospital
🇯🇵Chiba, Japan
Matsuyama Shimin Hospital
🇯🇵Ehime, Japan
Shinmatsudo Central General Hospital_Diabetes and Endocrinology
🇯🇵Chiba, Japan
Kimitsu Chuo Hospital
🇯🇵Chiba, Japan
Fukushima Medical University Hospital_Diabetes and Endocrinology
🇯🇵Fukushima, Japan
Ogaki Municipal Hospital_Diabetes and Nephrology
🇯🇵Gifu, Japan
Gunma University Hospital, Dept. of Endocrinology and Diabetes
🇯🇵Gunma, Japan
Iwate Medical University Uchimaru Medical Center, Division of Diabetes and Metabolism and Endocrine medicine
🇯🇵Iwate, Japan
Shimane Univ. HP, Dept of Endocrinology&Metabolism
🇯🇵Izumo, Shimane, Japan
Kawasaki Municipal Hospital_Diabetes and Endocrinology
🇯🇵Kanagawa, Japan
Kanto Rousai Hospital_Diabetes and Endocrinology
🇯🇵Kanagawa, Japan
St. Marianna University School of Medicine Hospital
🇯🇵Kanagawa, Japan
Urasoe General Hospital_Cardiology
🇯🇵Okinawa, Japan
Chibune Hospital_Diabetes and Endocrinology
🇯🇵Osaka, Japan
Osaki citizen hospital, Diabetes and metabolic disease
🇯🇵Osaki-shi, Miyagi, Japan
Karatsu Sekijuji Byoin
🇯🇵Saga, Japan
NTT East Japan Sapporo HP, Diabetes Mellitus & Int med Endo
🇯🇵Sapporo, Hokkaido, Japan
Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism Endocrinology
🇯🇵Sapporo-shi, Hokkaido, Japan
Aso Clinic
🇯🇵Shizuoka, Japan
Kyushu University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Fukuoka Sanno Hospital
🇯🇵Fukuoka, Japan
Sapporo Tonyobyo Kojosen Clinic
🇯🇵Hokkaido, Japan
University of Tsukuba Hospital_Diabetes and Endocrinology
🇯🇵Ibaraki, Japan
Japanese Red Cross Asahikawa Hospital
🇯🇵Hokkaido, Japan
Yokohama Rosai Hospital_Diabetes and Endocrinology
🇯🇵Kanagawa, Japan
Yokohama City University Medical Center_Endocrinology and Diabetes
🇯🇵Kanagawa, Japan
Kasugai Municipal Hospital_Cardiovascular Medicine
🇯🇵Kasugai-shi, Aichi, Japan
Nippon Medical School Musashikosugi Hospital_Neurological Surgery
🇯🇵Kawasaki-shi, Kanagawa-ken, Japan
Kochi Medical School Hospital_Endocrinology, Metabolism and Nephrology
🇯🇵Kochi, Japan
Kumamoto University Hospital, Diabetes, Metabo and Endo
🇯🇵Kumamoto-shi, Kumamoto, Japan
Kyoto University Hospital
🇯🇵Kyoto-shi, Kyoto, Japan
National Hospital Organization Kyoto Medical Center_Cardiology
🇯🇵Kyoto-shi, Kyoto, Japan
Kyoto City Hospital_Diabetes and Metabolism
🇯🇵Kyoto, Japan
Miura Central Clinic
🇯🇵Miura-shi, Kanagawa, Japan
Nagano Matsushiro General Hospital
🇯🇵Nagano, Japan
Shinbeppu Hospital_Endocrinology and Metabolism
🇯🇵Oita, Japan
Okayama Medical Center
🇯🇵Okayama-shi, Okayama, Japan
Okayama University Hospital_Neph. and Diabetes, Metabolism
🇯🇵Okayama, Japan
Okayama Rosai Hospital_Cardiology
🇯🇵Okayama, Japan
Japanese Red Cross Hamamatsu Hospital_Cardiology
🇯🇵Shizuoka, Japan
Sano Kosei General Hospital_Neph.& Endocrinology,Metab.
🇯🇵Tochigi, Japan
Gifu University Hospital
🇯🇵Tokyo, Japan
Nihon University Hospital_Internal Medicine
🇯🇵Tokyo, Japan
Tokyo Teishin Hospital
🇯🇵Tokyo, Japan
Nihonbashi Leiwa Naika Clinic
🇯🇵Tokyo, Japan
The Jikei University Hospital Dept of Diabetes, Metabolic
🇯🇵Tokyo, Japan
Keio University Hospital
🇯🇵Tokyo, Japan
Tokyo Women's Medical University_Diabetes and Metabolism
🇯🇵Tokyo, Japan
Tokyo Metropolitan Tama Medical Center
🇯🇵Tokyo, Japan
Tottori University Hospital_Endocrinology and Metabolism
🇯🇵Tottori, Japan
Tottori University Hospital_Pharmacotherapy
🇯🇵Tottori, Japan
Japanese Red Cross Wakayama Medical Center_Diabetology and Endocrinology
🇯🇵Wakayama, Japan
Wakayama Medical Univercity Hospital_Diabetes and Endocrinology
🇯🇵Wakayama, Japan
Yamagata University Hospital, Internal Medicine 3
🇯🇵Yamagata-shi, Yamagata, Japan
Shimonoseki Medical Center_Diabetes and Endocrinology
🇯🇵Yamaguchi, Japan
Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology