A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy (NCT05872022) | Clinical Trial Compass
By InvitationNot Applicable
A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy
United States, Spain, United Kingdom728 participantsStarted 2023-07-05
Plain-language 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.
Who can participate
Age range
15 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Infants with Major Congenital Malformation (MCM)
Timeframe: From date of conception (DOC) to pregnancy outcome for foetal losses or 12 months of infant age for live births