A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy

Enrolling by invitation

Conditions studied: Pregnancy, Obesity, Overweight

In brief

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.

Key facts

Study ID

NCT05872022

Run by

Novo Nordisk A/S

People needed

728

Starts

2023-07-05

Expected to finish

2032-12-30

Last updated by the study team

2026-01-14

Who can join

Age: 15 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Princeton, New Jersey, United States
• Novo Nordisk Investigational Site — Madrid, Spain
• Novo Nordisk Investigational Site — London, United Kingdom

Full record on ClinicalTrials.gov

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