Special Use - Results Surveillance on Long-term Use With Wegovy®
NCT ID: NCT06283667
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
1000 participants
OBSERVATIONAL
2024-06-11
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Wegovy®
Patients with obesity treated with Wegovy® (semaglutide) once weekly under real-world clinical practice conditions in Japan.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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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
Juntendo University Hospital_Tokyo
Bunkyo-ku, Tokyo, , Japan
Shinmatsudo Central General Hospital_Diabetes and Endocrinology
Chiba, , Japan
Toho University Medical Center Sakura Hospital
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
Fukuoka, , Japan
Fukuoka Kieikai Hospital_Diabetes and obesity centre
Fukuoka, , Japan
Fukuoka Sanno Hospital
Fukuoka, , Japan
Kyushu University Hospital
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, Dept. of Endocrinology and Diabetes
Gunma, , Japan
Hamamatsu University Hospital
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
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
St. Marianna University School of Medicine Hospital
Kanagawa, , Japan
Yokohama Rosai Hospital_Diabetes and Endocrinology
Kanagawa, , Japan
Showa University Fujigaoka Hospital_Internal Medicine
Kanagawa, , Japan
Yokohama City Minato Red Cross Hospital_Endocrinology
Kanagawa, , Japan
Yokohama City University Medical Center_Endocrinology and Diabetes
Kanagawa, , Japan
Tokai University Hospital_Nephrology, Endocrinology and Metabolism
Kanagawa, , Japan
Yokohama City University Medical Center_Nephrology and Hypertension
Kanahawa, , 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 General Hospital_Diabetes Center
Kumamoto, , Japan
Minamata City General Hospital & Medical Center_Metabolism
Kumamoto, , Japan
Kumamoto University Hospital, Diabetes, Metabo and Endo
Kumamoto-shi, Kumamoto, , Japan
Kure Medical Center and Chugoku Cancer Center
Kure-shi, Hiroshima, , Japan
Shin Koga Hospital
Kurume-shi, Fukuoka, , Japan
University Hospital Kyoto Prefectual University of Medicine
Kyoto, , Japan
Kyoto City Hospital_Diabetes and Metabolism
Kyoto, , Japan
Kyoto University Hospital
Kyoto-shi, Kyoto, , Japan
National Hospital Organization Kyoto Medical Center_Cardiology
Kyoto-shi, Kyoto, , Japan
Mie University Hospital_Mie
Mie, , Japan
Japanese Red Cross Ise Hospital_Diabetes and Metabolism
Mie, , Japan
Miura Central Clinic
Miura-shi, Kanagawa, , Japan
Aichi Medical University Hospital, Diabetes Medicine
Nagakute-shi, Aichi, , Japan
Nagano Matsushiro General Hospital_department of diet
Nagano, , Japan
University of the Ryukyus Hospital
Nakagami-gun, Okinawa-ken, , Japan
Iwate Medical University Uchimaru Medical Center, Division of Diabetes and Metabolism and Endocrine medicine
Numakunai, , Japan
Okayama University Hospital_Neph. and Diabetes, Metabolism
Okayama, , Japan
Okayama Rosai Hospital_Cardiology
Okayama, , Japan
Okayama Medical Center_Cardiology
Okayama-shi, Okayama, , Japan
Urasoe General Hospital_Cardiology
Okinawa, , Japan
Osaka National Hospital_Osaka
Osaka, , Japan
Osaka Metropolitan University Hospital_Lifestyle disease diabetes centre
Osaka, , Japan
Chibune Hospital_Diabetes and Endocrinology
Osaka, , Japan
Matsushita Memorial Hospital_Diabetes and Endocrinology
Osaka, , Japan
Kishiwada City Hospital_Endocrinology and Metabolism
Osaka, , Japan
Bellland Sogo Byoin_Endocrinology and Metabolism
Osaka, , Japan
Osaka City General Hospital_Endocrinology and Diabetes Mellitus
Osaka-shi, Osaka, , Japan
Osaki citizen hospital_Diabetes and metabolic disease
Osaki-shi, Miyagi, , Japan
Shinbeppu Hospital_Endocrinology and Metabolism
Ōita, , Japan
Karatsu Redcross Hospital_Diabetes Internal Medicine
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
Juntendo University Shizuoka Hospital_Diabetes and Endocrinology
Shizuoka, , Japan
JA Shizuoka Kohseiren Enshu Hospital_Internal Medicine
Shizuoka, , Japan
Hamamatsu Medical Center
Shizuoka, , Japan
Japanese Red Cross Hamamatsu Hospital_Cardiology
Shizuoka, , Japan
Chutoen General Medical Center_Diabetes and Endocrinology
Shizuoka, , Japan
Nagasaki Hospital_Internal Medicine
Tochigi, , Japan
Sano Kosei General Hospital_Neph.& Endocrinology,Metab.
Tochigi, , Japan
Tamaki Aozora Byoin_Diabetes and Endocrinology
Tokushima, , 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
Institute of Science Tokyo Hospital_Cardiology
Tokyo, , Japan
National Center for Child Health and Development_Internal medicine for women
Tokyo, , Japan
Keio University Hospital
Tokyo, , Japan
Tokyo Women's Medical University_Diabetes and Metabolism
Tokyo, , Japan
Kyorin University Hospital_Diabetes and Endocrinology
Tokyo, , Japan
Tokyo Metropolitan Tama Medical Center
Tokyo, , Japan
Tottori University Hospital_Endocrinology and Metabolism
Tottori, , Japan
Tottori University Hospital_Pharmacotherapy
Tottori, , Japan
Toyohashi Municipal Hospital
Toyohashi-shi, Aichi-ken, , 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
Yamaguchi Rosai Hospital_Diabetes and Endocrinology
Yamaguchi, , Japan
Yokohama City University Hospital, Endocrinology, Metabolism
Yokohama, Kanagawa, , Japan
Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology
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Countries
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Other Identifiers
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U1111-1266-3863
Identifier Type: OTHER
Identifier Source: secondary_id
NN9536-4872
Identifier Type: -
Identifier Source: org_study_id
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