A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy

Last updated: December 30, 2024
Sponsor: Novo Nordisk A/S
Overall Status: Active - Enrolling

Phase

N/A

Condition

Obesity

Diabetes Prevention

Pregnancy

Treatment

No Intervention

Clinical Study ID

NCT05872022
NN9536-4937
U1111-1273-4336
  • Ages 15-50
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 duringpregnancy for the treatment of obesity or overweight with at least oneweight-related comorbid condition.

  • Unexposed to Wegovy cohort: Have obesity or overweight with at least one weightrelated comorbid condition at conception

Exclusion

Exclusion Criteria:

  • Mental incapacity, unwillingness, or language barriers precluding adequateunderstanding or cooperation

  • Unexposed to Wegovy cohort: Exposure to Wegovy or other GLP-1 RA at any time duringpregnancy

Study Design

Total Participants: 728
Treatment Group(s): 1
Primary Treatment: No Intervention
Phase:
Study Start date:
July 05, 2023
Estimated Completion Date:
December 30, 2032

Connect with a study center

  • Novo Nordisk Investigational Site

    Madrid,
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    London,
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Princeton, New Jersey 08540
    United States

    Site Not Available

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