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Enrolling By InvitationNCT05872022

A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy

Wegovy® (Semaglutide 2.4 mg) Pregnancy Registry Study: A Prospective Cohort Study to Investigate Safety Outcomes of Exposure to Wegovy During Pregnancy

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
728 (estimated)
Sponsor
Novo Nordisk A/S · Industry
Sex
Female
Age
15 Years – 50 Years
Healthy volunteers

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERNo InterventionThis is a non-interventional study, therefore no intervention is used.

Timeline

Start date
2023-07-05
Primary completion
2032-10-31
Completion
2032-12-30
First posted
2023-05-23
Last updated
2026-01-14

Locations

3 sites across 3 countries: United States, Spain, United Kingdom

Source: ClinicalTrials.gov record NCT05872022. Inclusion in this directory is not an endorsement.