Enrolling By Invitation
OBSERVATIONAL
NCT05503927
A Study to Evaluate the Safety of Exposure to Wegovy During Pregnancy
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This is an observational, retrospective, cohort study using administrative insurance claims data. The aim of this non-interventional study (NIS) is to compare maternal, fetal and infant outcomes of women exposed to Wegovy during pregnancy to a reference population not exposed to Wegovy, so that participants and healthcare providers can make informed treatment decisions.
Interventions
Name:
No Intervention
Type:
OTHER
Description:
This is a non-interventional study, therefore no intervention is used.
Primary Outcomes
Measure:
Number of Infants with Major Congenital Malformation (MCM)
TimeFrame:
Birth up to 1 year of age
Description:
Number of infants with MCM is defined as an abnormality of body structure or function that is present at birth, is of prenatal origin (that is, birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention.
Trial Information
NCT ID
NCT05503927
Status
Enrolling By Invitation
Study Type
OBSERVATIONAL
Sponsor
Novo Nordisk A/S
Last Updated
December 15, 2025