A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy
NCT ID: NCT05872022
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
728 participants
OBSERVATIONAL
2023-07-05
2032-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants Exposed to Wegovy
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.
No Intervention
This is a non-interventional study, therefore no intervention is used.
Participants Unexposed to Wegovy or Other GLP-1 RAs
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.
No Intervention
This is a non-interventional study, therefore no intervention is used.
Interventions
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No Intervention
This is a non-interventional study, therefore no intervention is used.
Eligibility Criteria
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Inclusion Criteria
* 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
* Unexposed to Wegovy cohort: Exposure to Wegovy or other GLP-1 RA at any time during pregnancy
15 Years
50 Years
FEMALE
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Princeton, New Jersey, United States
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
London, , United Kingdom
Countries
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Other Identifiers
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U1111-1273-4336
Identifier Type: OTHER
Identifier Source: secondary_id
NN9536-4937
Identifier Type: -
Identifier Source: org_study_id