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Clinical Trials in the UK / NCT05872022
Enrolling by invitation Observational

A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy

NCT05872022 · tracked via the Priya Life Science UK tracker
Sponsor
Novo Nordisk A/S
Phase
Observational
Started
2023-07-05
Last updated
2026-01-14

Condition(s) studied

PregnancyObesityOverweight

Investigational drug(s) / intervention(s)

No Intervention

No Intervention: This is a non-interventional study, therefore no intervention is used.

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

Sex
FEMALE
Min age
15 Years
Max age
50 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of Infants with Major Congenital Malformation (MCM) — From date of conception (DOC) to pregnancy outcome for foetal losses or 12 months of infant age for live births
    Number of infants with MCM is defined as an abnormality of body structure or function that is present at birth; is of prenatal origin (that is, birth defect); has significant medical, social, or cosmetic consequences for the affected individual; and typically requires medical intervention.

Trial sites (3)

FacilityCityRegionStatus
Novo Nordisk Investigational Site Princeton New Jersey
Novo Nordisk Investigational Site Madrid Spain
Novo Nordisk Investigational Site London United Kingdom

More Novo Nordisk A/S trials in the UK

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A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity Active, not recruiting
Adverse Event Data Collection From External Registries on Nonacog Beta Pegol Enrolling by invitation
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Other trials for the same condition

A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight Active, not recruiting
A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity Active, not recruiting
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity Recruiting
AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss Active, not recruiting
A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05872022 on ClinicalTrials.gov ↗ ← All trials in the UK