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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1266-3863 | Other Identifier | World Health Organization (WHO) |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wegovy® | Patients with obesity treated with Wegovy® (semaglutide) once weekly under real-world clinical practice conditions in Japan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Reactions (ARs) | Measured as count of events | From baseline (week 0) to end of study (week 104) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AEs) | Measured as count of events | From baseline (week 0) to end of study (week 104) |
| Number of serious adverse events (SAEs) | Measured as count of events |
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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:
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.
Exclusion Criteria:
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Participants are patients with obesity treated with Wegovy® (semaglutide) once weekly under real-world clinical practice conditions in Japan.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Tokyo | Chiyoda City | 100-0005 | Japan | ||
| Jinnouchi Hospital_Internal Medicine |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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|
|
| From baseline (week 0) to end of study (week 104) |
| Number of Serious Adverse Reactions (SARs) | Measured as count of events | From baseline (week 0) to end of study (week 104) |
| Change in body weight (Percent (%)) | Measured as percent (%) | From baseline (week 0) to end of study (week 104) |
| Change in body weight (Kilograms (Kg)) | Measured in kilograms (Kg) | From baseline (week 0) to end of study (week 104) |
| Change in waist circumference | Measured in centimeters (cm) | From baseline (week 0) to end of study (week 104) |
| 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) |
| Change in body weight after treatment discontinuation | Measured as percent (%) | From treatment discontinuation after at least 12 weeks to end of study (week 104) |
| Kumamoto |
| Kumamoto, Japan |
| 862-0976 |
| Japan |
| Okazaki City Hospital | Aichi | 444-8553 | Japan |
| Nagoya City University Hospital_Obesity Treatment Center | Aichi | 467-8602 | Japan |
| Fujita Health University Hospital_Endocrinology, Diabetes and Metabolism | Aichi | 470-11-1 | Japan |
| Ichinomiyanishi Hospital | Aichi | 494-0001 | Japan |
| Nakadori General Hospital_Diabetes and Endocrinology | Akita | 010-8577 | Japan |
| Odate Municipal General Hospital_Endocrinology and Metabolism | Akita | 017-8550 | Japan |
| Akita University Hospital, Diabetes and Endocrinology | Akita-shi, Akita | 010-8543 | Japan |
| Hachinohe City Hospital_Diabetes and Metabolism | Aomori | 031-8555 | Japan |
| Juntendo University Hospital_Tokyo | Bunkyo-ku, Tokyo | 113-8431 | Japan |
| Shinmatsudo Central General Hospital_Diabetes and Endocrinology | Chiba | 270-0034 | Japan |
| Toho University Sakura Medical Center | Chiba | 285-8741 | Japan |
| Kimitsu Chuo Hospital_Diabetology and Endocrinology | Chiba | 292-0822 | Japan |
| Kameda Medical Center_Diabetes and Endocrinology | Chiba | 296-8602 | Japan |
| Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus | Chikushino-shi, Fukuoka | 818-8502 | Japan |
| Chiba University Hospital_Diabetes, Metabolism and Endocrinology | Chiyoda-ku, Tokyo | 100-0005 | Japan |
| Mikannohana Clinic | Ehime | 790-0034 | Japan |
| Matsuyama Shimin Hospital_Diabetes and Endocrinology | Ehime | 790-0067 | Japan |
| University of Fukui Hospital | Fukui | 910-1193 | Japan |
| National Hospital Organization Fukuokahigashi Medical Center_Diabetes and Endocrinology | Fukuoka | 811-3195 | Japan |
| Fukuoka Kieikai Hospital_Diabetes and obesity centre | Fukuoka | 813-0044 | Japan |
| Fukuoka Sanno Hospital_Diabetology and Endocrinology and Metabolism | Fukuoka | 814-0001 | Japan |
| Kyushu University Hospital_Endocrine Metab Diab inter med | Fukuoka-shi, Fukuoka | 812-8582 | Japan |
| Fukushima Medical University Hospital_Diabetes and Endocrinology | Fukushima | 960-1295 | Japan |
| Chuno Kosei Hospital_Endocrinology and Diabetes | Gifu | 501-3802 | Japan |
| Matsunami General Hospital_Diabetes and Endocrinology | Gifu | 501-6062 | Japan |
| Ogaki Municipal Hospital_Diabetes and Nephrology | Gifu | 503-8502 | Japan |
| Gunma University Hospital_Endocrinology and Diabetes | Gunma | 371-8511 | Japan |
| Hamamatsu University Hospital_Liver Internal Medicine | Hamamatsu-shi, Shizuoka | 431-3192 | Japan |
| Murakami Memorial Hospital_Diabetes Internal Medicine | Hiroshima | 722-0014 | Japan |
| Mazda Hospital_Diabetes | Hiroshima | 735-8585 | Japan |
| Sapporo Tonyobyo Kojosen Clinic | Hokkaido | 060-0807 | Japan |
| Japanese Red Cross Asahikawa Hospital_Diabetes and Endocrinology | Hokkaido | 070-8530 | Japan |
| Hyogo Medical University Hospital_Diabetes, Endocrinology and Metabolism | Hyōgo | 663-8131 | Japan |
| University of Tsukuba Hospital_Diabetes and Endocrinology | Ibaraki | 305-8576 | Japan |
| Shimane Univ. HP, Dept of Endocrinology&Metabolism | Izumo, Shimane | 691-8501 | Japan |
| Kagoshima University Hospital_Diabetes and Endocrinology | Kagoshima | 890-8520 | Japan |
| Kawasaki Municipal Hospital_Diabetes and Endocrinology | Kanagawa | 210-0013 | Japan |
| Kanto Rousai Hospital_Diabetes and Endocrinology | Kanagawa | 211-8510 | Japan |
| St. Marianna University School of Medicine Hospital | Kanagawa | 216-0015 | Japan |
| Yokohama Rosai Hospital_Diabetes and Endocrinology | Kanagawa | 222-0036 | Japan |
| Showa University Fujigaoka Hospital_Internal Medicine | Kanagawa | 227-8501 | Japan |
| Yokohama City Minato Red Cross Hospital_Endocrinology | Kanagawa | 231-8682 | Japan |
| Yokohama City University Medical Center_Endocrinology and Diabetes | Kanagawa | 232-0024 | Japan |
| Tokai University Hospital_Nephrology, Endocrinology and Metabolism | Kanagawa | 259-1193 | Japan |
| Yokohama City University Medical Center_Nephrology and Hypertension | Kanahawa | 232-0024 | Japan |
| Kasugai Municipal Hospital_Cardiovascular Medicine | Kasugai-shi, Aichi | 486-8510 | Japan |
| Nippon Medical School Musashikosugi Hospital_Neurological Surgery | Kawasaki-shi, Kanagawa-ken | 211-0063 | Japan |
| Kochi Medical School Hospital_Endocrinology, Metabolism and Nephrology | Kochi | 783-8505 | Japan |
| Kumamoto General Hospital_Diabetes Center | Kumamoto | 866-8660 | Japan |
| Minamata City General Hospital & Medical Center_Metabolism | Kumamoto | 867-0041 | Japan |
| Kumamoto University Hospital, Diabetes, Metabo and Endo | Kumamoto-shi, Kumamoto | 860-0811 | Japan |
| Kure Medical Center and Chugoku Cancer Center | Kure-shi, Hiroshima | 737-0023 | Japan |
| Shin Koga Hospital | Kurume-shi, Fukuoka | 830 8577 | Japan |
| University Hospital Kyoto Prefectual University of Medicine | Kyoto | 602-8566 | Japan |
| Kyoto City Hospital_Diabetes and Metabolism | Kyoto | 604-8845 | Japan |
| Kyoto University Hospital_Department of Diabetes, Endocr | Kyoto-shi, Kyoto | 606-8507 | Japan |
| National Hospital Organization Kyoto Medical Center_Cardiology | Kyoto-shi, Kyoto | 612-8555 | Japan |
| Mie University Hospital_Diabetes and Endocrinology | Mie | 514-8507 | Japan |
| Japanese Red Cross Ise Hospital_Diabetes and Metabolism | Mie | 516-8512 | Japan |
| Miura Central Clinic | Miura-shi, Kanagawa | 238-0101 | Japan |
| Aichi Medical University Hospital_Diabetes Medicine | Nagakute-shi, Aichi | 480-1195 | Japan |
| Nagano Matsushiro General Hospital_department of diet | Nagano | 381-1231 | Japan |
| University of the Ryukyus Hospital | Nakagami-gun, Okinawa-ken | 903-0125 | Japan |
| Iwate Medical University Uchimaru Medical Center, Division of Diabetes and Metabolism and Endocrine medicine | Numakunai | 020-8505 | Japan |
| Okayama University Hospital_Neph. and Diabetes, Metabolism | Okayama | 700-0914 | Japan |
| Okayama Rosai Hospital_Cardiology | Okayama | 702-8055 | Japan |
| Okayama Medical Center_Cardiology | Okayama-shi, Okayama | 701-1192 | Japan |
| Urasoe General Hospital_Cardiology | Okinawa | 901-2102 | Japan |
| Osaka National Hospital_Diabetes Internal Medicine | Osaka | 540-0006 | Japan |
| Osaka Metropolitan University Hospital_Lifestyle disease diabetes centre | Osaka | 545-0051 | Japan |
| Chibune Hospital_Diabetes and Endocrinology | Osaka | 555-0034 | Japan |
| Matsushita Memorial Hospital_Diabetes and Endocrinology | Osaka | 570-8540 | Japan |
| Kishiwada City Hospital_Endocrinology and Metabolism | Osaka | 596-8501 | Japan |
| Bellland Sogo Byoin_Endocrinology and Metabolism | Osaka | 599-8247 | Japan |
| Osaka City General Hospital_Endocrinology and Diabetes Mellitus | Osaka-shi, Osaka | 534-0021 | Japan |
| Osaki citizen hospital_Diabetes and metabolic disease | Osaki-shi, Miyagi | 989-6183 | Japan |
| Shinbeppu Hospital_Endocrinology and Metabolism | Ōita | 874-8538 | Japan |
| Karatsu Redcross Hospital_Diabetes Internal Medicine | Saga | 847-8588 | Japan |
| NTT East Japan Sapporo HP_Diabetes Mellitus & Int med Endo | Sapporo, Hokkaido | 060-8648 | Japan |
| Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism Endocrinology | Sapporo-shi, Hokkaido | 060-8543 | Japan |
| Aso Clinic | Shizuoka | 410-0041 | Japan |
| Juntendo University Shizuoka Hospital_Diabetes and Endocrinology | Shizuoka | 410-2295 | Japan |
| JA Shizuoka Kohseiren Enshu Hospital_Internal Medicine | Shizuoka | 430-0929 | Japan |
| Hamamatsu Medical Center_Endocrinology and Metabolism | Shizuoka | 432-8580 | Japan |
| Japanese Red Cross Hamamatsu Hospital_Cardiology | Shizuoka | 434-8533 | Japan |
| Chutoen General Medical Center_Diabetes and Endocrinology | Shizuoka | 436-8555 | Japan |
| Nagasaki Hospital_Internal Medicine | Tochigi | 326-0053 | Japan |
| Sano Kosei General Hospital_Neph.& Endocrinology,Metab. | Tochigi | 327-8511 | Japan |
| Tamaki Aozora Byoin_Diabetes and Endocrinology | Tokushima | 779-3125 | Japan |
| Gifu University Hospital_The Third Dept. of Internal Medicine | Tokyo | 100-0005 | Japan |
| Nihon University Hospital_Internal Medicine | Tokyo | 101-8309 | Japan |
| Tokyo Teishin Hospital | Tokyo | 102-8798 | Japan |
| Nihonbashi Leiwa Naika Clinic | Tokyo | 103-0027 | Japan |
| The Jikei University Hospital Dept of Diabetes, Metabolic | Tokyo | 105-8471 | Japan |
| Institute of Science Tokyo Hospital_Cardiology | Tokyo | 113-8519 | Japan |
| National Center for Child Health and Development_Internal medicine for women | Tokyo | 157-8535 | Japan |
| Keio University Hospital_Neurology | Tokyo | 160-8582 | Japan |
| Tokyo Women's Medical University_Diabetes and Metabolism | Tokyo | 162-0054 | Japan |
| Kyorin University Hospital_Diabetes and Endocrinology | Tokyo | 181-8611 | Japan |
| Tokyo Metropolitan Tama Medical Center | Tokyo | 183-8524 | Japan |
| Tottori University Hospital_Endocrinology and Metabolism | Tottori | 683-8504 | Japan |
| Tottori University Hospital_Pharmacotherapy | Tottori | 683-8504 | Japan |
| Toyohashi Municipal Hospital | Toyohashi-shi, Aichi-ken | 441-8085 | Japan |
| Japanese Red Cross Wakayama Medical Center_Diabetology and Endocrinology | Wakayama | 640-8558 | Japan |
| Wakayama Medical Univercity Hospital_Diabetes and Endocrinology | Wakayama | 641-8510 | Japan |
| Yamagata University Hospital, Internal Medicine 3 | Yamagata-shi, Yamagata | 990-9585 | Japan |
| Shimonoseki Medical Center_Diabetes and Endocrinology | Yamaguchi | 750-0061 | Japan |
| Yamaguchi Rosai Hospital_Diabetes and Endocrinology | Yamaguchi | 756-0095 | Japan |
| Yokohama City University Hospital_Endocrinology, Metabolism | Yokohama, Kanagawa | 236-0004 | Japan |
| Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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