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ENROLLING BY INVITATION

NCT06283667

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

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

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).

Official title: A Multi-centre, Prospective, Non-interventional, Single-armed, 104 Weeks Post-marketing Study to Investigate Safety and Clinical Parameters of Wegovy® Once Weekly in Patients With Obesity Disease Under Real-world Clinical Practice Conditions

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2024-06-11

Completion Date

2028-01-31

Last Updated

2025-10-29

Healthy Volunteers

Not specified

Conditions

Obesity

Interventions

DRUG

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.

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

Locations (112)

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (112)