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

NCT07055607 | Enrolling By Invitation

• 2 other identifiers: NN9536-8189U1111-1308-1428
• Study Type: observational
• Target: 1,250
• Locations: 3 countries
• Sites: 30

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Absolute change in body weight (kilograms [kg])

  Measured in kg.

  From baseline (0 months) to the end of observation (24 months)

• Percentage change in body weight (percentage [%])

  Measured in %.

  From baseline (0 months) to the end of observation (24 months)

Secondary Outcomes (45)

• Absolute change in waist circumference (centimeters [cm])

  From baseline (0 months) to the end of observation (24 months)

• Absolute change in waist-to-height ratio

  From baseline (0 months) to the end of observation (24 months)

• Percentage change in waist circumference (%)

  From baseline (0 months) to the end of observation (24 months)

• Number of participants who achieve greater than or equal to (>=) 5 percent body weight reduction (Yes/No)

  From baseline (0 months) to the end of observation (24 months)

• For Switzerland: Number of participants who achieve >=7 percent body weight reduction (Yes/No)

  From baseline (0 months) to the end of observation (22 months)

Study Arms (1)

Wegovy®

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

Drug: Semaglutide

Interventions

Semaglutide 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.

Also known as: Wegovy®

Wegovy®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (30)

CAP Sarrià

Barcelona, 08017, Spain

Location

CAP Sants

Barcelona, 08028, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Centro de Salud Cartagena Casco Antiguo

Cartagena, 30201, Spain

Location

Hospital Vithas Sevilla

Castilleja de la Cuesta, 41950, Spain

Location

Hospital Univ. Virgen de la Arrixaca

El Palmar (Murcia), 30120, Spain

Location

Clínica de Endocrinología y Nutrición Dr. Bellido

Ferrol, 15401, Spain

Location

Ginegetafe S.L.

Getafe (Madrid), 28901, Spain

Location

Centro de Salud La Cuesta

La Cuesta (Santa Cruz de Tenerife), 38320, Spain

Location

Hospital Univ. de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, 35010, Spain

Location

Hospital Universitario Sanitas Virgen del Mar

Madrid, 28016, Spain

Location

Hospital Quirónsalud Málaga

Málaga, 29004, Spain

Location

Hospital Univ. Central de Asturias

Oviedo, 33011, Spain

Location

Hospital Son Espases

Palma de Mallorca, 07120, Spain

Location

Hospiten Roca_Ginecología

San Bartolomé de Tirajana (Las Palmas), 35100, Spain

Location

Praxis Dr. Schäfer, Bern

Bern, 3013, Switzerland

Location

Hôpitaux Universitaires de Genève HUG

Geneva, 1211, Switzerland

Location

Luzerner Kantonsspital

Lucerne, 6004, Switzerland

Location

Clinica Moncucco

Lugano, 6900, Switzerland

Location

Centre médical de l'obésité et du diabète

Neuchâtel, 2000, Switzerland

Location

Kantonsspital Olten

Olten, 4600, Switzerland

Location

Praxis Prof. Dr. med. G. Rudofsky

Olten, 4600, Switzerland

Location

Stoffwechselzentrum St. Gallen

Sankt Gallen, 9016, Switzerland

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Sandwell Health Campus

West Bromwich, West Midlands, B71 4HJ, United Kingdom

Location

Barnsley Hospital

Barnsley, S75 2EP, United Kingdom

Location

Hull Royal Infirmary

Hull, HU3 2JZ, United Kingdom

Location

St Thomas' Hospital - Diabetes

London, SE1 7EH, United Kingdom

Location

Luton and Dunstable University Hospital

Luton, LU4 0DZ, United Kingdom

Location

St George's Hospital

Tooting, SW17 0RE, United Kingdom

Location

MeSH Terms

Conditions

Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 9, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): August 15, 2028
• Study Completion (Estimated): August 15, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

ES (15); CH (9); GB (6)