Special Use - Results Surveillance on Long-term Use With Wegovy®
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
2 other identifiers
observational
1,071
1 country
111
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2024
Typical duration for all trials
111 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2024
CompletedFirst Posted
Study publicly available on registry
February 28, 2024
CompletedStudy Start
First participant enrolled
June 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
April 22, 2026
April 1, 2026
3.6 years
February 21, 2024
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Adverse Reactions (ARs)
Measured as count of events
From baseline (week 0) to end of study (week 104)
Secondary Outcomes (8)
Number of Adverse Events (AEs)
From baseline (week 0) to end of study (week 104)
Number of serious adverse events (SAEs)
From baseline (week 0) to end of study (week 104)
Number of Serious Adverse Reactions (SARs)
From baseline (week 0) to end of study (week 104)
Change in body weight (Percent (%))
From baseline (week 0) to end of study (week 104)
Change in body weight (Kilograms (Kg))
From baseline (week 0) to end of study (week 104)
- +3 more secondary outcomes
Study Arms (1)
Wegovy®
Patients with obesity treated with Wegovy® (semaglutide) once weekly under real-world clinical practice conditions in Japan.
Interventions
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.
Eligibility Criteria
Participants are patients with obesity treated with Wegovy® (semaglutide) once weekly under real-world clinical practice conditions in Japan.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (112)
Novo Nordisk Investigational Site
Tokyo, Chiyoda City, 100-0005, Japan
Jinnouchi Hospital_Internal Medicine
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2024
First Posted
February 28, 2024
Study Start
June 11, 2024
Primary Completion (Estimated)
January 31, 2028
Study Completion (Estimated)
January 31, 2028
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com