Clinical trial NCT06283667: Special Use - Results Surveillance on Long-term Use With Wegovy®
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Adverse Reactions (ARs)
timeFrame: From baseline (week 0) to end of study (week 104)
Secondary outcomes:
measure: Number of Adverse Events (AEs)
timeFrame: From baseline (week 0) to end of study (week 104)
measure: Number of serious adverse events (SAEs)
timeFrame: From baseline (week 0) to end of study (week 104)
measure: Number of Serious Adverse Reactions (SARs)
timeFrame: From baseline (week 0) to end of study (week 104)
measure: Change in body weight (Percent (%))
timeFrame: From baseline (week 0) to end of study (week 104)
measure: Change in body weight (Kilograms (Kg))
timeFrame: From baseline (week 0) to end of study (week 104)
measure: Change in waist circumference
timeFrame: From baseline (week 0) to end of study (week 104)
measure: Change in BMI (Body Mass Index)
timeFrame: From baseline (week 0) to end of study (week 104)
measure: Change in body weight after treatment discontinuation
timeFrame: From treatment discontinuation after at least 12 weeks to end of study (week 104)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
state: Chiyoda City
city: Kumamoto-shi
country: Japan
facility: Jinnouchi Hospital
state: Kumamoto, Japan
city: Aichi
country: Japan
facility: Okazaki City Hospital
city: Aichi
country: Japan
facility: Nagoya City University Hospital_Obesity Treatment Center
city: Aichi
country: Japan
facility: Fujita Health University Hospital_Endocrinology, Diabetes and Metabolism
city: Aichi
country: Japan
facility: Ichinomiyanishi Hospital
city: Akita-shi, Akita
country: Japan
facility: Akita University Hospital, Diabetes and Endocrinology
city: Akita
country: Japan
facility: Nakadori General Hospital_Diabetes and Endocrinology
city: Akita
country: Japan
facility: Odate Municipal General Hospital
city: Aomori
country: Japan
facility: Hachinohe City Hospital_Diabetes and Metabolism
city: Bunkyo-ku, Tokyo
country: Japan
facility: Juntendo University Hospital_Tokyo
city: Chiba
country: Japan
facility: Shinmatsudo Central General Hospital_Diabetes and Endocrinology
city: Chiba
country: Japan
facility: Toho University Medical Center Sakura Hospital
city: Chiba
country: Japan
facility: Kimitsu Chuo Hospital
city: Chiba
country: Japan
facility: Kameda Medical Center_Diabetes and Endocrinology
city: Chikushino-shi, Fukuoka
country: Japan
facility: Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus
city: Chiyoda-ku, Tokyo
country: Japan
facility: Chiba University Hospital_Diabetes, Metabolism and Endocrinology
city: Ehime
country: Japan
facility: Mikannohana Clinic
city: Ehime
country: Japan
facility: Matsuyama Shimin Hospital
city: Fukui
country: Japan
facility: University of Fukui Hospital
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Fukuokahigashi Medical Center
city: Fukuoka
country: Japan
facility: Fukuoka Kieikai Hospital_Diabetes and obesity centre
city: Fukuoka
country: Japan
facility: Fukuoka Sanno Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital_Diabetes and Endocrinology
city: Gifu
country: Japan
facility: Chuno Kosei Hospital_Endocrinology and Diabetes
city: Gifu
country: Japan
facility: Matsunami General Hospital
city: Gifu
country: Japan
facility: Ogaki Municipal Hospital_Diabetes and Nephrology
city: Gunma
country: Japan
facility: Gunma University Hospital, Dept. of Endocrinology and Diabetes
city: Hamamatsu-shi, Shizuoka
country: Japan
facility: Hamamatsu University Hospital
city: Hiroshima
country: Japan
facility: Murakami Memorial Hospital
city: Hiroshima
country: Japan
facility: Mazda Hospital
city: Hokkaido
country: Japan
facility: Sapporo Tonyobyo Kojosen Clinic
city: Hokkaido
country: Japan
facility: Japanese Red Cross Asahikawa Hospital
city: Hyogo
country: Japan
facility: Hyogo Medical University Hospital_Diabetes, Endocrinology and Metabolism
city: Ibaraki
country: Japan
facility: University of Tsukuba Hospital_Diabetes and Endocrinology
city: Iwate
country: Japan
facility: Iwate Medical University Uchimaru Medical Center, Division of Diabetes and Metabolism and Endocrine medicine
city: Izumo, Shimane
country: Japan
facility: Shimane Univ. HP, Dept of Endocrinology&Metabolism
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital_Diabetes and Endocrinology
city: Kanagawa
country: Japan
facility: Kawasaki Municipal Hospital_Diabetes and Endocrinology
city: Kanagawa
country: Japan
facility: Kanto Rousai Hospital_Diabetes and Endocrinology
city: Kanagawa
country: Japan
facility: St. Marianna University School of Medicine Hospital
city: Kanagawa
country: Japan
facility: Yokohama Rosai Hospital_Diabetes and Endocrinology
city: Kanagawa
country: Japan
facility: Showa University Fujigaoka Hospital_Internal Medicine
city: Kanagawa
country: Japan
facility: Yokohama City Minato Red Cross Hospital
city: Kanagawa
country: Japan
facility: Yokohama City University Medical Center_Endocrinology and Diabetes
city: Kanahawa
country: Japan
facility: Yokohama City University Medical Center_Nephrology and Hypertension
city: Kasugai-shi, Aichi
country: Japan
facility: Kasugai Municipal Hospital_Cardiovascular Medicine
city: Kawasaki-shi, Kanagawa-ken
country: Japan
facility: Nippon Medical School Musashikosugi Hospital_Neurological Surgery
city: Kochi
country: Japan
facility: Kochi Medical School Hospital_Endocrinology, Metabolism and Nephrology
city: Kumamoto-shi, Kumamoto
country: Japan
facility: Kumamoto University Hospital, Diabetes, Metabo and Endo
city: Kumamoto
country: Japan
facility: Kumamoto General Hospital_Diabetes Center
city: Kumamoto
country: Japan
facility: Minamata City General Hospital & Medical Center
city: Kure-shi, Hiroshima
country: Japan
facility: Kure Medical Center and Chugoku Cancer Center
city: Kurume-shi, Fukuoka
country: Japan
facility: Shin Koga Hospital
city: Kyoto-shi, Kyoto
country: Japan
facility: Kyoto University Hospital
city: Kyoto-shi, Kyoto
country: Japan
facility: National Hospital Organization Kyoto Medical Center_Cardiology
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectual University of Medicine
city: Kyoto
country: Japan
facility: Kyoto City Hospital_Diabetes and Metabolism
city: Mie
country: Japan
facility: Mie University Hospital_Mie
city: Mie
country: Japan
facility: Japanese Red Cross Ise Hospital
city: Miura-shi, Kanagawa
country: Japan
facility: Miura Central Clinic
city: Nagakute-shi, Aichi
country: Japan
facility: Aichi Medical University Hospital, Diabetes Medicine
city: Nagano
country: Japan
facility: Nagano Matsushiro General Hospital
city: Nakagami-gun, Okinawa-ken
country: Japan
facility: University of the Ryukyus Hospital
city: Oita
country: Japan
facility: Shinbeppu Hospital_Endocrinology and Metabolism
city: Okayama-shi, Okayama
country: Japan
facility: Okayama Medical Center
city: Okayama
country: Japan
facility: Okayama University Hospital_Neph. and Diabetes, Metabolism
city: Okayama
country: Japan
facility: Okayama Rosai Hospital_Cardiology
city: Okinawa
country: Japan
facility: Urasoe General Hospital_Cardiology
city: Osaka-shi, Osaka
country: Japan
facility: Osaka City General Hospital_Endocrinology and Diabetes Mellitus
city: Osaka
country: Japan
facility: Osaka National Hospital_Osaka
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital_Lifestyle disease diabetes centre
city: Osaka
country: Japan
facility: Chibune Hospital_Diabetes and Endocrinology
city: Osaka
country: Japan
facility: Matsushita Memorial Hospital
city: Osaka
country: Japan
facility: Kishiwada City Hospital_Endocrinology and Metabolism
city: Osaka
country: Japan
facility: Bellland Sogo Byoin
city: Osaki-shi, Miyagi
country: Japan
facility: Osaki citizen hospital, Diabetes and metabolic disease
city: Saga
country: Japan
facility: Karatsu Sekijuji Byoin
city: Sapporo, Hokkaido
country: Japan
facility: NTT East Japan Sapporo HP, Diabetes Mellitus & Int med Endo
city: Sapporo-shi, Hokkaido
country: Japan
facility: Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism Endocrinology
city: Shizuoka
country: Japan
facility: Aso Clinic
city: Shizuoka
country: Japan
facility: Juntendo University Shizuoka Hospital_Diabetes and Endocrinology
city: Shizuoka
country: Japan
facility: JA Shizuoka Kohseiren Enshu Hospital_Internal Medicine
city: Shizuoka
country: Japan
facility: Hamamatsu Medical Center
city: Shizuoka
country: Japan
facility: Japanese Red Cross Hamamatsu Hospital_Cardiology
city: Shizuoka
country: Japan
facility: Chutoen General Medical Center_Diabetes and Endocrinology
city: Tochigi
country: Japan
facility: Nagasaki Hospital
city: Tochigi
country: Japan
facility: Sano Kosei General Hospital_Neph.& Endocrinology,Metab.
city: Tokushima
country: Japan
facility: Tamaki Aozora Byoin
city: Tokyo
country: Japan
facility: Gifu University Hospital
city: Tokyo
country: Japan
facility: Nihon University Hospital_Internal Medicine
city: Tokyo
country: Japan
facility: Tokyo Teishin Hospital
city: Tokyo
country: Japan
facility: Nihonbashi Leiwa Naika Clinic
city: Tokyo
country: Japan
facility: The Jikei University Hospital Dept of Diabetes, Metabolic
city: Tokyo
country: Japan
facility: Institute of Science Tokyo Hospital_Cardiology
city: Tokyo
country: Japan
facility: National Center for Child Health and Development_Internal medicine for women
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University_Diabetes and Metabolism
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Tama Medical Center
city: Tottori
country: Japan
facility: Tottori University Hospital_Endocrinology and Metabolism
city: Tottori
country: Japan
facility: Tottori University Hospital_Pharmacotherapy
city: Toyohashi-shi, Aichi-ken
country: Japan
facility: Toyohashi Municipal Hospital
city: Wakayama
country: Japan
facility: Japanese Red Cross Wakayama Medical Center_Diabetology and Endocrinology
city: Wakayama
country: Japan
facility: Wakayama Medical Univercity Hospital_Diabetes and Endocrinology
city: Yamagata-shi, Yamagata
country: Japan
facility: Yamagata University Hospital, Internal Medicine 3
city: Yamaguchi
country: Japan
facility: Shimonoseki Medical Center_Diabetes and Endocrinology
city: Yamaguchi
country: Japan
facility: Yamaguchi Rosai Hospital
city: Yokohama, Kanagawa
country: Japan
facility: Yokohama City University Hospital, Endocrinology, Metabolism
facility: Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: