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NCT05872022 | ENROLLING BY INVITATION | Pregnancy

A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy
Sponsor:

Novo Nordisk A/S

Brief 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.

Condition or disease

Pregnancy

Obesity

Overweight

Intervention/treatment

No Intervention

Study Type : OBSERVATIONAL
Estimated Enrollment : 728 participants
Official Title : Wegovy® (Semaglutide 2.4 mg) Pregnancy Registry Study: A Prospective Cohort Study to Investigate Safety Outcomes of Exposure to Wegovy During Pregnancy
Actual Study Start Date : 2023-07-05
Estimated Primary Completion Date : 2032-10-31
Estimated Study Completion Date : 2032-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 15 Years to 50 Years
Sexes Eligible for Study: FEMALE
Criteria
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
A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy

Location Details

NCT05872022

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, New Jersey

Novo Nordisk Investigational Site

Princeton, New Jersey, United States, 08540

Not yet recruiting

Spain,

Novo Nordisk Investigational Site

Madrid, Spain,

Not yet recruiting

United Kingdom,

Novo Nordisk Investigational Site

London, United Kingdom,