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

NCT ID: NCT06283667

Last Updated: 2025-10-29

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-11

Study Completion Date

2028-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type 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.

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.

Intervention Type DRUG

Other Intervention Names

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Wegovy®

Eligibility Criteria

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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:

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Jinnouchi Hospital_Internal Medicine

Kumamoto, Kumamoto, Japan, Japan

Site Status

Okazaki City Hospital

Aichi, , Japan

Site Status

Nagoya City University Hospital_Obesity Treatment Center

Aichi, , Japan

Site Status

Fujita Health University Hospital_Endocrinology, Diabetes and Metabolism

Aichi, , Japan

Site Status

Ichinomiyanishi Hospital

Aichi, , Japan

Site Status

Nakadori General Hospital_Diabetes and Endocrinology

Akita, , Japan

Site Status

Odate Municipal General Hospital_Endocrinology and Metabolism

Akita, , Japan

Site Status

Akita University Hospital, Diabetes and Endocrinology

Akita-shi, Akita, , Japan

Site Status

Hachinohe City Hospital_Diabetes and Metabolism

Aomori, , Japan

Site Status

Juntendo University Hospital_Tokyo

Bunkyo-ku, Tokyo, , Japan

Site Status

Shinmatsudo Central General Hospital_Diabetes and Endocrinology

Chiba, , Japan

Site Status

Toho University Medical Center Sakura Hospital

Chiba, , Japan

Site Status

Kimitsu Chuo Hospital_Diabetology and Endocrinology

Chiba, , Japan

Site Status

Kameda Medical Center_Diabetes and Endocrinology

Chiba, , Japan

Site Status

Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus

Chikushino-shi, Fukuoka, , Japan

Site Status

Chiba University Hospital_Diabetes, Metabolism and Endocrinology

Chiyoda-ku, Tokyo, , Japan

Site Status

Mikannohana Clinic

Ehime, , Japan

Site Status

Matsuyama Shimin Hospital_Diabetes and Endocrinology

Ehime, , Japan

Site Status

University of Fukui Hospital

Fukui, , Japan

Site Status

National Hospital Organization Fukuokahigashi Medical Center

Fukuoka, , Japan

Site Status

Fukuoka Kieikai Hospital_Diabetes and obesity centre

Fukuoka, , Japan

Site Status

Fukuoka Sanno Hospital

Fukuoka, , Japan

Site Status

Kyushu University Hospital

Fukuoka-shi, Fukuoka, , Japan

Site Status

Fukushima Medical University Hospital_Diabetes and Endocrinology

Fukushima, , Japan

Site Status

Chuno Kosei Hospital_Endocrinology and Diabetes

Gifu, , Japan

Site Status

Matsunami General Hospital_Diabetes and Endocrinology

Gifu, , Japan

Site Status

Ogaki Municipal Hospital_Diabetes and Nephrology

Gifu, , Japan

Site Status

Gunma University Hospital, Dept. of Endocrinology and Diabetes

Gunma, , Japan

Site Status

Hamamatsu University Hospital

Hamamatsu-shi, Shizuoka, , Japan

Site Status

Murakami Memorial Hospital_Diabetes Internal Medicine

Hiroshima, , Japan

Site Status

Mazda Hospital_Diabetes

Hiroshima, , Japan

Site Status

Sapporo Tonyobyo Kojosen Clinic

Hokkaido, , Japan

Site Status

Japanese Red Cross Asahikawa Hospital

Hokkaido, , Japan

Site Status

Hyogo Medical University Hospital_Diabetes, Endocrinology and Metabolism

Hyōgo, , Japan

Site Status

University of Tsukuba Hospital_Diabetes and Endocrinology

Ibaraki, , Japan

Site Status

Shimane Univ. HP, Dept of Endocrinology&Metabolism

Izumo, Shimane, , Japan

Site Status

Kagoshima University Hospital_Diabetes and Endocrinology

Kagoshima, , Japan

Site Status

Kawasaki Municipal Hospital_Diabetes and Endocrinology

Kanagawa, , Japan

Site Status

Kanto Rousai Hospital_Diabetes and Endocrinology

Kanagawa, , Japan

Site Status

St. Marianna University School of Medicine Hospital

Kanagawa, , Japan

Site Status

Yokohama Rosai Hospital_Diabetes and Endocrinology

Kanagawa, , Japan

Site Status

Showa University Fujigaoka Hospital_Internal Medicine

Kanagawa, , Japan

Site Status

Yokohama City Minato Red Cross Hospital_Endocrinology

Kanagawa, , Japan

Site Status

Yokohama City University Medical Center_Endocrinology and Diabetes

Kanagawa, , Japan

Site Status

Tokai University Hospital_Nephrology, Endocrinology and Metabolism

Kanagawa, , Japan

Site Status

Yokohama City University Medical Center_Nephrology and Hypertension

Kanahawa, , Japan

Site Status

Kasugai Municipal Hospital_Cardiovascular Medicine

Kasugai-shi, Aichi, , Japan

Site Status

Nippon Medical School Musashikosugi Hospital_Neurological Surgery

Kawasaki-shi, Kanagawa-ken, , Japan

Site Status

Kochi Medical School Hospital_Endocrinology, Metabolism and Nephrology

Kochi, , Japan

Site Status

Kumamoto General Hospital_Diabetes Center

Kumamoto, , Japan

Site Status

Minamata City General Hospital & Medical Center_Metabolism

Kumamoto, , Japan

Site Status

Kumamoto University Hospital, Diabetes, Metabo and Endo

Kumamoto-shi, Kumamoto, , Japan

Site Status

Kure Medical Center and Chugoku Cancer Center

Kure-shi, Hiroshima, , Japan

Site Status

Shin Koga Hospital

Kurume-shi, Fukuoka, , Japan

Site Status

University Hospital Kyoto Prefectual University of Medicine

Kyoto, , Japan

Site Status

Kyoto City Hospital_Diabetes and Metabolism

Kyoto, , Japan

Site Status

Kyoto University Hospital

Kyoto-shi, Kyoto, , Japan

Site Status

National Hospital Organization Kyoto Medical Center_Cardiology

Kyoto-shi, Kyoto, , Japan

Site Status

Mie University Hospital_Mie

Mie, , Japan

Site Status

Japanese Red Cross Ise Hospital_Diabetes and Metabolism

Mie, , Japan

Site Status

Miura Central Clinic

Miura-shi, Kanagawa, , Japan

Site Status

Aichi Medical University Hospital, Diabetes Medicine

Nagakute-shi, Aichi, , Japan

Site Status

Nagano Matsushiro General Hospital_department of diet

Nagano, , Japan

Site Status

University of the Ryukyus Hospital

Nakagami-gun, Okinawa-ken, , Japan

Site Status

Iwate Medical University Uchimaru Medical Center, Division of Diabetes and Metabolism and Endocrine medicine

Numakunai, , Japan

Site Status

Okayama University Hospital_Neph. and Diabetes, Metabolism

Okayama, , Japan

Site Status

Okayama Rosai Hospital_Cardiology

Okayama, , Japan

Site Status

Okayama Medical Center_Cardiology

Okayama-shi, Okayama, , Japan

Site Status

Urasoe General Hospital_Cardiology

Okinawa, , Japan

Site Status

Osaka National Hospital_Osaka

Osaka, , Japan

Site Status

Osaka Metropolitan University Hospital_Lifestyle disease diabetes centre

Osaka, , Japan

Site Status

Chibune Hospital_Diabetes and Endocrinology

Osaka, , Japan

Site Status

Matsushita Memorial Hospital_Diabetes and Endocrinology

Osaka, , Japan

Site Status

Kishiwada City Hospital_Endocrinology and Metabolism

Osaka, , Japan

Site Status

Bellland Sogo Byoin_Endocrinology and Metabolism

Osaka, , Japan

Site Status

Osaka City General Hospital_Endocrinology and Diabetes Mellitus

Osaka-shi, Osaka, , Japan

Site Status

Osaki citizen hospital_Diabetes and metabolic disease

Osaki-shi, Miyagi, , Japan

Site Status

Shinbeppu Hospital_Endocrinology and Metabolism

Ōita, , Japan

Site Status

Karatsu Redcross Hospital_Diabetes Internal Medicine

Saga, , Japan

Site Status

NTT East Japan Sapporo HP_Diabetes Mellitus & Int med Endo

Sapporo, Hokkaido, , Japan

Site Status

Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism Endocrinology

Sapporo-shi, Hokkaido, , Japan

Site Status

Aso Clinic

Shizuoka, , Japan

Site Status

Juntendo University Shizuoka Hospital_Diabetes and Endocrinology

Shizuoka, , Japan

Site Status

JA Shizuoka Kohseiren Enshu Hospital_Internal Medicine

Shizuoka, , Japan

Site Status

Hamamatsu Medical Center

Shizuoka, , Japan

Site Status

Japanese Red Cross Hamamatsu Hospital_Cardiology

Shizuoka, , Japan

Site Status

Chutoen General Medical Center_Diabetes and Endocrinology

Shizuoka, , Japan

Site Status

Nagasaki Hospital_Internal Medicine

Tochigi, , Japan

Site Status

Sano Kosei General Hospital_Neph.& Endocrinology,Metab.

Tochigi, , Japan

Site Status

Tamaki Aozora Byoin_Diabetes and Endocrinology

Tokushima, , Japan

Site Status

Gifu University Hospital

Tokyo, , Japan

Site Status

Nihon University Hospital_Internal Medicine

Tokyo, , Japan

Site Status

Tokyo Teishin Hospital

Tokyo, , Japan

Site Status

Nihonbashi Leiwa Naika Clinic

Tokyo, , Japan

Site Status

The Jikei University Hospital Dept of Diabetes, Metabolic

Tokyo, , Japan

Site Status

Institute of Science Tokyo Hospital_Cardiology

Tokyo, , Japan

Site Status

National Center for Child Health and Development_Internal medicine for women

Tokyo, , Japan

Site Status

Keio University Hospital

Tokyo, , Japan

Site Status

Tokyo Women's Medical University_Diabetes and Metabolism

Tokyo, , Japan

Site Status

Kyorin University Hospital_Diabetes and Endocrinology

Tokyo, , Japan

Site Status

Tokyo Metropolitan Tama Medical Center

Tokyo, , Japan

Site Status

Tottori University Hospital_Endocrinology and Metabolism

Tottori, , Japan

Site Status

Tottori University Hospital_Pharmacotherapy

Tottori, , Japan

Site Status

Toyohashi Municipal Hospital

Toyohashi-shi, Aichi-ken, , Japan

Site Status

Japanese Red Cross Wakayama Medical Center_Diabetology and Endocrinology

Wakayama, , Japan

Site Status

Wakayama Medical Univercity Hospital_Diabetes and Endocrinology

Wakayama, , Japan

Site Status

Yamagata University Hospital, Internal Medicine 3

Yamagata-shi, Yamagata, , Japan

Site Status

Shimonoseki Medical Center_Diabetes and Endocrinology

Yamaguchi, , Japan

Site Status

Yamaguchi Rosai Hospital_Diabetes and Endocrinology

Yamaguchi, , Japan

Site Status

Yokohama City University Hospital, Endocrinology, Metabolism

Yokohama, Kanagawa, , Japan

Site Status

Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology

, ,

Site Status

Countries

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Japan

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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