A Two-year Prospective, Observational Study of Wegovy in Real-world Clinical Practice

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-21

Study Completion Date

2027-10-25

Brief Summary

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This observational study will explore how Wegovy® (Semaglutide) is used in everyday situations, how it might affect things like weight, body mass index (BMI) and waist circumference, and what kind of impact it could have on overall quality of life. The overall purpose of this study is to understand how Wegovy impacts weight when used as part of regular medical care. Participants will be treated with Wegovy as prescribed to the participant by their doctor, in accordance with normal clinical practice. The study will last for about two years.

Detailed Description

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Conditions

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Obesity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Wegovy®

Participants will be treated with Wegovy according to the local labels in Spain, Switzerland and the United Kingdom (UK).

Semaglutide

Intervention Type DRUG

Participants will be treated with commercially available Wegovy according to routine clinical practice and is purely at the discretion of the treating physician. Only individuals receiving Wegovy reimbursed by the healthcare system in their respective countries are included in the study.

Interventions

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Semaglutide

Participants will be treated with commercially available Wegovy according to routine clinical practice and is purely at the discretion of the treating physician. Only individuals receiving Wegovy reimbursed by the healthcare system in their respective countries are included in the study.

Intervention Type DRUG

Other Intervention Names

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Wegovy®

Eligibility Criteria

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Inclusion Criteria

* Signed consent obtained before any study-related activities (study-related activities are any pro-cedure related to recording of data according to the protocol).
* Are eligible for Wegovy and are due to initiate treatment for the first time within the study period; 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, age above or equal to 18 years at time of signing informed consent.
* Have at least one reported weight measurement documented at baseline or within 28 days prior to baseline.
* Participants must be able to complete the electronic patient reported outcome (ePRO) questionnaires on a compatible electronic device with internet access.
* Fulfil the respective reimbursement criteria in the visit prior to / at baseline in Switzerland and United Kingdom (UK).

Exclusion Criteria

* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Presence of a documented refusal or unwillingness to participate in research.
* Previous treatment with other obesity management pharmacotherapy or any glucagon like pep-tide-1 (GLP- 1) receptor agonist up to 90 days prior to baseline in Switzerland and UK.
* Previous treatment with other obesity management pharmacotherapy or any GLP- 1 receptor agonist up to 30 days prior to baseline in Spain.
* Pregnant or women of childbearing potential and not using a highly effective contraceptive method.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation with the study requirements.
* Individuals who have reported plans to move out in the next 12 months to an area not serviced by their current site.
* Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) in Spain and UK.
* Participant has had a prior serious allergic reaction to semaglutide or any of the ingredients in Wegovy.
* Have had Saxenda reimbursed by basic mandatory health insurance for a cumulative period of more than 12 months prior to baseline in Switzerland.
* Documented history of diabetes mellitus type 1 and type 2 in Spain.
* Presence of diabetic complications and/or at risk of hypoglycaemia (with a documented history of frequent hypoglycaemia) in Spain.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Site Status RECRUITING