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NCT Number: NCT06283667

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Tokyo, Chiyoda City, Japan

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

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

Treatment and study plan

semaglutide

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.

Other names: Wegovy®

Primary outcomes

  1. Number of Adverse Reactions (ARs)

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

    Measured as count of events

Secondary outcomes

  1. Number of Adverse Events (AEs)

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

    Measured as count of events

  2. Number of serious adverse events (SAEs)

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

    Measured as count of events

  3. Number of Serious Adverse Reactions (SARs)

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

    Measured as count of events

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

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

    Measured as percent (%)

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

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

    Measured in kilograms (Kg)

  6. Change in waist circumference

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

    Measured in centimeters (cm)

  7. Change in BMI (Body Mass Index)

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

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

  8. Change in body weight after treatment discontinuation

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

    Measured as percent (%)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 28, 2024
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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