A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy

Novo Nordisk

Status: Invitation-only

Conditions: Overweight; Obesity; Pregnancy

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT05872022

U1111-1273-4336 (Other Identifier)

NN9536-4937

Details and patient eligibility

About

This is an observational, prospective Wegovy (semaglutide 2.4 milligram [mg]) Pregnancy Registry Study. The aim of this study is to compare the maternal, foetal, and infant outcomes of pregnant women who are exposed to Wegovy during pregnancy for the treatment of obesity or overweight with at least one weight-related comorbid condition with outcomes in an internal comparison cohort of pregnant women with obesity or overweight with at least one weight related comorbid condition at conception and who are not exposed to Wegovy or other glucagon-like peptide-1 receptor agonists (GLP-1 RAs) during pregnancy. Infant outcomes will be assessed throughout the infant's first year of life, with active data collection by the registry occurring at 4 and 12 months after delivery.

Enrollment: 728 estimated patients

Sex: Female

Ages: 15 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed consent obtained before any study-related activities
• Female 15-50 years of age at the time of signing consent
• Currently or recently pregnant
• Resident of country included in the study
• Authorisation for her HCP(s) to provide data to the registry
• Exposed to Wegovy cohort: Exposure to at least one dose of Wegovy at any time during pregnancy for the treatment of obesity or overweight with at least one weight-related comorbid condition.
• Unexposed to Wegovy cohort: Have obesity or overweight with at least one weight related comorbid condition at conception

Exclusion criteria

• Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation
• Unexposed to Wegovy cohort: Exposure to Wegovy or other GLP-1 RA at any time during pregnancy

Trial design

728 participants in 2 patient groups

Participants Exposed to Wegovy

Description:

Pregnant women who are exposed to Wegovy at any time during pregnancy for the treatment of obesity or overweight with at least one weight-related comorbid condition will be observed in this prospective observational study.

Treatment:

Other: No Intervention

Participants Unexposed to Wegovy or Other GLP-1 RAs

Description:

Pregnant women who have overweight with at least one weight-related comorbid condition or who have obesity at conception and who are not exposed to Wegovy or other GLP-1 RAs at any time during pregnancy but who may be exposed to other products for weight management will be observed in this prospective observational study.

Treatment:

Other: No Intervention