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

Novo Nordisk

Status

Enrolling

Conditions

Obesity

Treatments

Drug: Semaglutide

Study type

Observational

Funder types

Industry

Identifiers

NCT07055607

U1111-1308-1428 (Other Identifier)

NN9536-8189

Details and patient eligibility

About

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.

Enrollment

1,250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.