AzTrials
AzTrials

ObesityNCT06283667

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

An observational study of Obesity, run by Novo Nordisk A/S at 112 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Obesity
What is being tested?
Semaglutide
How many people
1,071 participants
Where
112 sitesin 2 countries
Study dates
11 Jun 2024to 31 Jan 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Child, Adult, Older adult

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

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

112 sites in 2 countries.

112 sites in 2 countries

Japan111 sites

  • Okazaki City Hospital

    Aichi, 444-8553

  • Nagoya City University Hospital_Obesity Treatment Center

    Aichi, 467-8602

  • Fujita Health University Hospital_Endocrinology, Diabetes and Metabolism

    Aichi, 470-11-1

  • Ichinomiyanishi Hospital

    Aichi, 494-0001

  • Nakadori General Hospital_Diabetes and Endocrinology

    Akita, 010-8577

  • Odate Municipal General Hospital_Endocrinology and Metabolism

    Akita, 017-8550

  • Akita University Hospital, Diabetes and Endocrinology

    Akita-shi, Akita, 010-8543

  • Hachinohe City Hospital_Diabetes and Metabolism

    Aomori, 031-8555

  • Juntendo University Hospital_Tokyo

    Bunkyo-ku, Tokyo, 113-8431

  • Shinmatsudo Central General Hospital_Diabetes and Endocrinology

    Chiba, 270-0034

  • Toho University Sakura Medical Center

    Chiba, 285-8741

  • Kimitsu Chuo Hospital_Diabetology and Endocrinology

    Chiba, 292-0822

  • Kameda Medical Center_Diabetes and Endocrinology

    Chiba, 296-8602

  • Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus

    Chikushino-shi, Fukuoka, 818-8502

  • Chiba University Hospital_Diabetes, Metabolism and Endocrinology

    Chiyoda-ku, Tokyo, 100-0005

  • Mikannohana Clinic

    Ehime, 790-0034

  • Matsuyama Shimin Hospital_Diabetes and Endocrinology

    Ehime, 790-0067

  • University of Fukui Hospital

    Fukui, 910-1193

  • National Hospital Organization Fukuokahigashi Medical Center_Diabetes and Endocrinology

    Fukuoka, 811-3195

  • Fukuoka Kieikai Hospital_Diabetes and obesity centre

    Fukuoka, 813-0044

  • Fukuoka Sanno Hospital_Diabetology and Endocrinology and Metabolism

    Fukuoka, 814-0001

  • Kyushu University Hospital_Endocrine Metab Diab inter med

    Fukuoka-shi, Fukuoka, 812-8582

  • Fukushima Medical University Hospital_Diabetes and Endocrinology

    Fukushima, 960-1295

  • Chuno Kosei Hospital_Endocrinology and Diabetes

    Gifu, 501-3802

  • Matsunami General Hospital_Diabetes and Endocrinology

    Gifu, 501-6062

  • Ogaki Municipal Hospital_Diabetes and Nephrology

    Gifu, 503-8502

  • Gunma University Hospital_Endocrinology and Diabetes

    Gunma, 371-8511

  • Hamamatsu University Hospital_Liver Internal Medicine

    Hamamatsu-shi, Shizuoka, 431-3192

  • Murakami Memorial Hospital_Diabetes Internal Medicine

    Hiroshima, 722-0014

  • Mazda Hospital_Diabetes

    Hiroshima, 735-8585

  • Sapporo Tonyobyo Kojosen Clinic

    Hokkaido, 060-0807

  • Japanese Red Cross Asahikawa Hospital_Diabetes and Endocrinology

    Hokkaido, 070-8530

  • Hyogo Medical University Hospital_Diabetes, Endocrinology and Metabolism

    Hyōgo, 663-8131

  • University of Tsukuba Hospital_Diabetes and Endocrinology

    Ibaraki, 305-8576

  • Shimane Univ. HP, Dept of Endocrinology&Metabolism

    Izumo, Shimane, 691-8501

  • Kagoshima University Hospital_Diabetes and Endocrinology

    Kagoshima, 890-8520

  • Kawasaki Municipal Hospital_Diabetes and Endocrinology

    Kanagawa, 210-0013

  • Kanto Rousai Hospital_Diabetes and Endocrinology

    Kanagawa, 211-8510

  • St. Marianna University School of Medicine Hospital

    Kanagawa, 216-0015

  • Yokohama Rosai Hospital_Diabetes and Endocrinology

    Kanagawa, 222-0036

  • Showa University Fujigaoka Hospital_Internal Medicine

    Kanagawa, 227-8501

  • Yokohama City Minato Red Cross Hospital_Endocrinology

    Kanagawa, 231-8682

  • Yokohama City University Medical Center_Endocrinology and Diabetes

    Kanagawa, 232-0024

  • Tokai University Hospital_Nephrology, Endocrinology and Metabolism

    Kanagawa, 259-1193

  • Yokohama City University Medical Center_Nephrology and Hypertension

    Kanahawa, 232-0024

  • Kasugai Municipal Hospital_Cardiovascular Medicine

    Kasugai-shi, Aichi, 486-8510

  • Nippon Medical School Musashikosugi Hospital_Neurological Surgery

    Kawasaki-shi, Kanagawa-ken, 211-0063

  • Kochi Medical School Hospital_Endocrinology, Metabolism and Nephrology

    Kochi, 783-8505

  • Jinnouchi Hospital_Internal Medicine

    Kumamoto, Kumamoto, Japan, 862-0976

  • Kumamoto General Hospital_Diabetes Center

    Kumamoto, 866-8660

  • Minamata City General Hospital & Medical Center_Metabolism

    Kumamoto, 867-0041

  • Kumamoto University Hospital, Diabetes, Metabo and Endo

    Kumamoto-shi, Kumamoto, 860-0811

  • Kure Medical Center and Chugoku Cancer Center

    Kure-shi, Hiroshima, 737-0023

  • Shin Koga Hospital

    Kurume-shi, Fukuoka, 830 8577

  • University Hospital Kyoto Prefectual University of Medicine

    Kyoto, 602-8566

  • Kyoto City Hospital_Diabetes and Metabolism

    Kyoto, 604-8845

  • Kyoto University Hospital_Department of Diabetes, Endocr

    Kyoto-shi, Kyoto, 606-8507

  • National Hospital Organization Kyoto Medical Center_Cardiology

    Kyoto-shi, Kyoto, 612-8555

  • Mie University Hospital_Diabetes and Endocrinology

    Mie, 514-8507

  • Japanese Red Cross Ise Hospital_Diabetes and Metabolism

    Mie, 516-8512

  • Miura Central Clinic

    Miura-shi, Kanagawa, 238-0101

  • Aichi Medical University Hospital_Diabetes Medicine

    Nagakute-shi, Aichi, 480-1195

  • Nagano Matsushiro General Hospital_department of diet

    Nagano, 381-1231

  • University of the Ryukyus Hospital

    Nakagami-gun, Okinawa-ken, 903-0125

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

    Numakunai, 020-8505

  • Shinbeppu Hospital_Endocrinology and Metabolism

    Ōita, 874-8538

  • Okayama University Hospital_Neph. and Diabetes, Metabolism

    Okayama, 700-0914

  • Okayama Rosai Hospital_Cardiology

    Okayama, 702-8055

  • Okayama Medical Center_Cardiology

    Okayama-shi, Okayama, 701-1192

  • Urasoe General Hospital_Cardiology

    Okinawa, 901-2102

  • Osaka National Hospital_Diabetes Internal Medicine

    Osaka, 540-0006

  • Osaka Metropolitan University Hospital_Lifestyle disease diabetes centre

    Osaka, 545-0051

  • Chibune Hospital_Diabetes and Endocrinology

    Osaka, 555-0034

  • Matsushita Memorial Hospital_Diabetes and Endocrinology

    Osaka, 570-8540

  • Kishiwada City Hospital_Endocrinology and Metabolism

    Osaka, 596-8501

  • Bellland Sogo Byoin_Endocrinology and Metabolism

    Osaka, 599-8247

  • Osaka City General Hospital_Endocrinology and Diabetes Mellitus

    Osaka-shi, Osaka, 534-0021

  • Osaki citizen hospital_Diabetes and metabolic disease

    Osaki-shi, Miyagi, 989-6183

  • Karatsu Redcross Hospital_Diabetes Internal Medicine

    Saga, 847-8588

  • Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism Endocrinology

    Sapporo-shi, Hokkaido, 060-8543

  • NTT East Japan Sapporo HP_Diabetes Mellitus & Int med Endo

    Sapporo, Hokkaido, 060-8648

  • Aso Clinic

    Shizuoka, 410-0041

  • Juntendo University Shizuoka Hospital_Diabetes and Endocrinology

    Shizuoka, 410-2295

  • JA Shizuoka Kohseiren Enshu Hospital_Internal Medicine

    Shizuoka, 430-0929

  • Hamamatsu Medical Center_Endocrinology and Metabolism

    Shizuoka, 432-8580

  • Japanese Red Cross Hamamatsu Hospital_Cardiology

    Shizuoka, 434-8533

  • Chutoen General Medical Center_Diabetes and Endocrinology

    Shizuoka, 436-8555

  • Nagasaki Hospital_Internal Medicine

    Tochigi, 326-0053

  • Sano Kosei General Hospital_Neph.& Endocrinology,Metab.

    Tochigi, 327-8511

  • Tamaki Aozora Byoin_Diabetes and Endocrinology

    Tokushima, 779-3125

  • Novo Nordisk Investigational Site

    Tokyo, Chiyoda City, 100-0005

  • Gifu University Hospital_The Third Dept. of Internal Medicine

    Tokyo, 100-0005

  • Nihon University Hospital_Internal Medicine

    Tokyo, 101-8309

  • Tokyo Teishin Hospital

    Tokyo, 102-8798

  • Nihonbashi Leiwa Naika Clinic

    Tokyo, 103-0027

  • The Jikei University Hospital Dept of Diabetes, Metabolic

    Tokyo, 105-8471

  • Institute of Science Tokyo Hospital_Cardiology

    Tokyo, 113-8519

  • National Center for Child Health and Development_Internal medicine for women

    Tokyo, 157-8535

  • Keio University Hospital_Neurology

    Tokyo, 160-8582

  • Tokyo Women's Medical University_Diabetes and Metabolism

    Tokyo, 162-0054

  • Kyorin University Hospital_Diabetes and Endocrinology

    Tokyo, 181-8611

  • Tokyo Metropolitan Tama Medical Center

    Tokyo, 183-8524

  • Tottori University Hospital_Endocrinology and Metabolism

    Tottori, 683-8504

  • Tottori University Hospital_Pharmacotherapy

    Tottori, 683-8504

  • Toyohashi Municipal Hospital

    Toyohashi-shi, Aichi-ken, 441-8085

  • Japanese Red Cross Wakayama Medical Center_Diabetology and Endocrinology

    Wakayama, 640-8558

  • Wakayama Medical Univercity Hospital_Diabetes and Endocrinology

    Wakayama, 641-8510

  • Yamagata University Hospital, Internal Medicine 3

    Yamagata-shi, Yamagata, 990-9585

  • Shimonoseki Medical Center_Diabetes and Endocrinology

    Yamaguchi, 750-0061

  • Yamaguchi Rosai Hospital_Diabetes and Endocrinology

    Yamaguchi, 756-0095

  • Yokohama City University Hospital_Endocrinology, Metabolism

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

Location not given1 site

  • Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology

About this study

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

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).

Conditions
Obesity
Being tested
Semaglutide
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

    Also called Wegovy®

    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.

Study groups in NCT06283667
Study groupRoleWhat they receive
Wegovy®Patients with obesity treated with Wegovy® (semaglutide) once weekly under real-world clinical practice conditions in Japan.
Receives: Drug: Semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Adverse Reactions (ARs)

    Measured as count of events

    Measured: From baseline (week 0) to end of study (week 104)

Secondary outcomes (8)

  1. Number of Adverse Events (AEs)

    Measured as count of events

    Measured: From baseline (week 0) to end of study (week 104)

  2. Number of serious adverse events (SAEs)

    Measured as count of events

    Measured: From baseline (week 0) to end of study (week 104)

  3. Number of Serious Adverse Reactions (SARs)

    Measured as count of events

    Measured: From baseline (week 0) to end of study (week 104)

  4. Change in body weight (Percent (%))

    Measured as percent (%)

    Measured: From baseline (week 0) to end of study (week 104)

  5. Change in body weight (Kilograms (Kg))

    Measured in kilograms (Kg)

    Measured: From baseline (week 0) to end of study (week 104)

  6. Change in waist circumference

    Measured in centimeters (cm)

    Measured: From baseline (week 0) to end of study (week 104)

  7. Change in BMI (Body Mass Index)

    Measured in kilogram per meter square (kg/m^2)

    Measured: From baseline (week 0) to end of study (week 104)

  8. Change in body weight after treatment discontinuation

    Measured as percent (%)

    Measured: From treatment discontinuation after at least 12 weeks to end of study (week 104)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start11 Jun 2024
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,071 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06283667
Sponsor's protocol ID
NN9536-4872
Other IDs
U1111-1266-3863
Status last verified
Apr 2026
First submitted
21 Feb 2024
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by Novo Nordisk A/S at 112 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Adverse Reactions (ARs) (time frame: From baseline (week 0) to end of study (week 104)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06283667.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in