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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Drug: Semaglutide

• Study Type: Observational
• Enrollment (Actual): 1071

Contacts and Locations

Study Locations

• • • Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology
• Japan
  • Aichi, Japan, 444-8553
    • Okazaki City Hospital
  • Aichi, Japan, 494-0001
    • Ichinomiyanishi Hospital
  • Aichi, Japan, 470-11-1
    • Fujita Health University Hospital_Endocrinology, Diabetes and Metabolism
  • Aichi, Japan, 467-8602
    • Nagoya City University Hospital_Obesity Treatment Center
  • Akita, Japan, 010-8577
    • Nakadori General Hospital_Diabetes and Endocrinology
  • Akita, Japan, 017-8550
    • Odate Municipal General Hospital_Endocrinology and Metabolism
  • Akita-shi, Akita, Japan, 010-8543
    • Akita University Hospital, Diabetes and Endocrinology
  • Aomori, Japan, 031-8555
    • Hachinohe City Hospital_Diabetes and Metabolism
  • Bunkyo-ku, Tokyo, Japan, 113-8431
    • Juntendo University Hospital_Tokyo
  • Chiba, Japan, 285-8741
    • Toho University Sakura Medical Center
  • Chiba, Japan, 270-0034
    • Shinmatsudo Central General Hospital_Diabetes and Endocrinology
  • Chiba, Japan, 296-8602
    • Kameda Medical Center_Diabetes and Endocrinology
  • Chiba, Japan, 292-0822
    • Kimitsu Chuo Hospital_Diabetology and Endocrinology
  • Chikushino-shi, Fukuoka, Japan, 818-8502
    • Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus
  • Chiyoda-ku, Tokyo, Japan, 100-0005
    • Chiba University Hospital_Diabetes, Metabolism and Endocrinology
  • Ehime, Japan, 790-0034
    • Mikannohana Clinic
  • Ehime, Japan, 790-0067
    • Matsuyama Shimin Hospital_Diabetes and Endocrinology
  • Fukui, Japan, 910-1193
    • University of Fukui Hospital
  • Fukuoka, Japan, 813-0044
    • Fukuoka Kieikai Hospital_Diabetes and obesity centre
  • Fukuoka, Japan, 811-3195
    • National Hospital Organization Fukuokahigashi Medical Center_Diabetes and Endocrinology
  • Fukuoka, Japan, 814-0001
    • Fukuoka Sanno Hospital_Diabetology and Endocrinology and Metabolism
  • Fukuoka-shi, Fukuoka, Japan, 812-8582
    • Kyushu University Hospital_Endocrine Metab Diab inter med
  • Fukushima, Japan, 960-1295
    • Fukushima Medical University Hospital_Diabetes and Endocrinology
  • Gifu, Japan, 503-8502
    • Ogaki Municipal Hospital_Diabetes and Nephrology
  • Gifu, Japan, 501-3802
    • Chuno Kosei Hospital_Endocrinology and Diabetes
  • Gifu, Japan, 501-6062
    • Matsunami General Hospital_Diabetes and Endocrinology
  • Gunma, Japan, 371-8511
    • Gunma University Hospital_Endocrinology and Diabetes
  • Hamamatsu-shi, Shizuoka, Japan, 431-3192
    • Hamamatsu University Hospital_Liver Internal Medicine
  • Hiroshima, Japan, 722-0014
    • Murakami Memorial Hospital_Diabetes Internal Medicine
  • Hiroshima, Japan, 735-8585
    • Mazda Hospital_Diabetes
  • Hokkaido, Japan, 060-0807
    • Sapporo Tonyobyo Kojosen Clinic
  • Hokkaido, Japan, 070-8530
    • Japanese Red Cross Asahikawa Hospital_Diabetes and Endocrinology
  • Hyōgo, Japan, 663-8131
    • Hyogo Medical University Hospital_Diabetes, Endocrinology and Metabolism
  • Ibaraki, Japan, 305-8576
    • University of Tsukuba Hospital_Diabetes and Endocrinology
  • Izumo, Shimane, Japan, 691-8501
    • Shimane Univ. HP, Dept of Endocrinology&Metabolism
  • Kagoshima, Japan, 890-8520
    • Kagoshima University Hospital_Diabetes and Endocrinology
  • Kanagawa, Japan, 216-0015
    • St. Marianna University School of Medicine Hospital
  • Kanagawa, Japan, 232-0024
    • Yokohama City University Medical Center_Endocrinology and Diabetes
  • Kanagawa, Japan, 210-0013
    • Kawasaki Municipal Hospital_Diabetes and Endocrinology
  • Kanagawa, Japan, 222-0036
    • Yokohama Rosai Hospital_Diabetes and Endocrinology
  • Kanagawa, Japan, 211-8510
    • Kanto Rousai Hospital_Diabetes and Endocrinology
  • Kanagawa, Japan, 227-8501
    • Showa University Fujigaoka Hospital_Internal Medicine
  • Kanagawa, Japan, 231-8682
    • Yokohama City Minato Red Cross Hospital_Endocrinology
  • Kanagawa, Japan, 259-1193
    • Tokai University Hospital_Nephrology, Endocrinology and Metabolism
  • Kanahawa, Japan, 232-0024
    • Yokohama City University Medical Center_Nephrology and Hypertension
  • Kasugai-shi, Aichi, Japan, 486-8510
    • Kasugai Municipal Hospital_Cardiovascular Medicine
  • Kawasaki-shi, Kanagawa-ken, Japan, 211-0063
    • Nippon Medical School Musashikosugi Hospital_Neurological Surgery
  • Kochi, Japan, 783-8505
    • Kochi Medical School Hospital_Endocrinology, Metabolism and Nephrology
  • Kumamoto, Japan, 866-8660
    • Kumamoto General Hospital_Diabetes Center
  • Kumamoto, Japan, 867-0041
    • Minamata City General Hospital & Medical Center_Metabolism
  • Kumamoto-shi, Kumamoto, Japan, 860-0811
    • Kumamoto University Hospital, Diabetes, Metabo and Endo
  • Kure-shi, Hiroshima, Japan, 737-0023
    • Kure Medical Center and Chugoku Cancer Center
  • Kurume-shi, Fukuoka, Japan, 830 8577
    • Shin Koga Hospital
  • Kyoto, Japan, 604-8845
    • Kyoto City Hospital_Diabetes and Metabolism
  • Kyoto, Japan, 602-8566
    • University Hospital Kyoto Prefectual University of Medicine
  • Kyoto-shi, Kyoto, Japan, 612-8555
    • National Hospital Organization Kyoto Medical Center_Cardiology
  • Kyoto-shi, Kyoto, Japan, 606-8507
    • Kyoto University Hospital_Department of Diabetes, Endocr
  • Mie, Japan, 516-8512
    • Japanese Red Cross Ise Hospital_Diabetes and Metabolism
  • Mie, Japan, 514-8507
    • Mie University Hospital_Diabetes and Endocrinology
  • Miura-shi, Kanagawa, Japan, 238-0101
    • Miura Central Clinic
  • Nagakute-shi, Aichi, Japan, 480-1195
    • Aichi Medical University Hospital_Diabetes Medicine
  • Nagano, Japan, 381-1231
    • Nagano Matsushiro General Hospital_department of diet
  • Nakagami-gun, Okinawa-ken, Japan, 903-0125
    • University of the Ryukyus Hospital
  • Numakunai, Japan, 020-8505
    • Iwate Medical University Uchimaru Medical Center, Division of Diabetes and Metabolism and Endocrine medicine
  • Okayama, Japan, 700-0914
    • Okayama University Hospital_Neph. and Diabetes, Metabolism
  • Okayama, Japan, 702-8055
    • Okayama Rosai Hospital_Cardiology
  • Okayama-shi, Okayama, Japan, 701-1192
    • Okayama Medical Center_Cardiology
  • Okinawa, Japan, 901-2102
    • Urasoe General Hospital_Cardiology
  • Osaka, Japan, 555-0034
    • Chibune Hospital_Diabetes and Endocrinology
  • Osaka, Japan, 545-0051
    • Osaka Metropolitan University Hospital_Lifestyle disease diabetes centre
  • Osaka, Japan, 596-8501
    • Kishiwada City Hospital_Endocrinology and Metabolism
  • Osaka, Japan, 570-8540
    • Matsushita Memorial Hospital_Diabetes and Endocrinology
  • Osaka, Japan, 599-8247
    • Bellland Sogo Byoin_Endocrinology and Metabolism
  • Osaka, Japan, 540-0006
    • Osaka National Hospital_Diabetes Internal Medicine
  • Osaka-shi, Osaka, Japan, 534-0021
    • Osaka City General Hospital_Endocrinology and Diabetes Mellitus
  • Osaki-shi, Miyagi, Japan, 989-6183
    • Osaki citizen hospital_Diabetes and metabolic disease
  • Saga, Japan, 847-8588
    • Karatsu Redcross Hospital_Diabetes Internal Medicine
  • Sapporo, Hokkaido, Japan, 060-8648
    • NTT East Japan Sapporo HP_Diabetes Mellitus & Int med Endo
  • Sapporo-shi, Hokkaido, Japan, 060-8543
    • Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism Endocrinology
  • Shizuoka, Japan, 410-0041
    • Aso Clinic
  • Shizuoka, Japan, 434-8533
    • Japanese Red Cross Hamamatsu Hospital_Cardiology
  • Shizuoka, Japan, 410-2295
    • Juntendo University Shizuoka Hospital_Diabetes and Endocrinology
  • Shizuoka, Japan, 430-0929
    • JA Shizuoka Kohseiren Enshu Hospital_Internal Medicine
  • Shizuoka, Japan, 436-8555
    • Chutoen General Medical Center_Diabetes and Endocrinology
  • Shizuoka, Japan, 432-8580
    • Hamamatsu Medical Center_Endocrinology and Metabolism
  • Tochigi, Japan, 327-8511
    • Sano Kosei General Hospital_Neph.& Endocrinology,Metab.
  • Tochigi, Japan, 326-0053
    • Nagasaki Hospital_Internal Medicine
  • Tokushima, Japan, 779-3125
    • Tamaki Aozora Byoin_Diabetes and Endocrinology
  • Tokyo, Japan, 102-8798
    • Tokyo Teishin Hospital
  • Tokyo, Japan, 183-8524
    • Tokyo Metropolitan Tama Medical Center
  • Tokyo, Japan, 105-8471
    • The Jikei University Hospital Dept of Diabetes, Metabolic
  • Tokyo, Japan, 103-0027
    • Nihonbashi Leiwa Naika Clinic
  • Tokyo, Japan, 101-8309
    • Nihon University Hospital_Internal Medicine
  • Tokyo, Japan, 162-0054
    • Tokyo Women's Medical University_Diabetes and Metabolism
  • Tokyo, Japan, 113-8519
    • Institute of Science Tokyo Hospital_Cardiology
  • Tokyo, Japan, 157-8535
    • National Center for Child Health and Development_Internal medicine for women
  • Tokyo, Japan, 181-8611
    • Kyorin University Hospital_Diabetes and Endocrinology
  • Tokyo, Japan, 100-0005
    • Gifu University Hospital_The Third Dept. of Internal Medicine
  • Tokyo, Japan, 160-8582
    • Keio University Hospital_Neurology
  • Tottori, Japan, 683-8504
    • Tottori University Hospital_Endocrinology and Metabolism
  • Tottori, Japan, 683-8504
    • Tottori University Hospital_Pharmacotherapy
  • Toyohashi-shi, Aichi-ken, Japan, 441-8085
    • Toyohashi Municipal Hospital
  • Wakayama, Japan, 640-8558
    • Japanese Red Cross Wakayama Medical Center_Diabetology and Endocrinology
  • Wakayama, Japan, 641-8510
    • Wakayama Medical Univercity Hospital_Diabetes and Endocrinology
  • Yamagata-shi, Yamagata, Japan, 990-9585
    • Yamagata University Hospital, Internal Medicine 3
  • Yamaguchi, Japan, 750-0061
    • Shimonoseki Medical Center_Diabetes and Endocrinology
  • Yamaguchi, Japan, 756-0095
    • Yamaguchi Rosai Hospital_Diabetes and Endocrinology
  • Yokohama, Kanagawa, Japan, 236-0004
    • Yokohama City University Hospital_Endocrinology, Metabolism
  • Ōita, Japan, 874-8538
    • Shinbeppu Hospital_Endocrinology and Metabolism
  • Chiyoda City
    • Tokyo, Chiyoda City, Japan, 100-0005
      • Novo Nordisk Investigational Site
  • Kumamoto, Japan
    • Kumamoto, Kumamoto, Japan, Japan, 862-0976
      • Jinnouchi Hospital_Internal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Participants are patients with obesity treated with Wegovy® (semaglutide) once weekly under real-world clinical practice conditions in Japan.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Wegovy®; Patients with obesity treated with Wegovy® (semaglutide) once weekly under real-world clinical practice conditions in Japan.

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.; Other Names: Wegovy®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Reactions (ARs)	Measured as count of events	From baseline (week 0) to end of study (week 104)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2024
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; semaglutide
• Other Study ID Numbers: NN9536-4872; U1111-1266-3863 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No