A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy

NCT05872022 | Enrolling By Invitation

• 2 other identifiers: NN9536-4937U1111-1273-4336
• Study Type: observational
• Target: 728
• Locations: 3 countries
• Sites: 3

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.

Conditions

Pregnancy; Obesity; Overweight

Outcome Measures

Primary Outcomes (1)

• Number of Infants with Major Congenital Malformation (MCM)

  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.

  From date of conception (DOC) to pregnancy outcome for foetal losses or 12 months of infant age for live births

Secondary Outcomes (10)

• Number of Infants with Minor Congenital Malformation

  From DOC to pregnancy outcome for foetal losses or 12 months of infant age for live births

• Number of Pregnant Participants With Pre-eclampsia

  From 20 0/7 gestational weeks to 6 weeks

• Number of Pregnant Participants With Eclampsia

  From 20 0/7 gestational weeks to 6 weeks

• Number of Pregnant Participants Experiencing Spontaneous Abortion

  From date of conception to 19 6/7 gestational weeks

• Number of Pregnant Participants Experiencing Stillbirth

  From 20 0/7 gestational weeks to pregnancy outcome (week 40)

Study Arms (2)

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.

Other: No Intervention

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.

Other: No Intervention

Interventions

No Intervention OTHER

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

Participants Exposed to Wegovy; Participants Unexposed to Wegovy or Other GLP-1 RAs

Eligibility Criteria

• Age: 15 Years - 50 Years
• Gender Eligibility Details: This is a study of prenatal exposure to Wegovy in pregnant women.
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant participants exposed to Wegovy during pregnancy, and pregnant participants who were 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 with obesity and overweight were to be observed prospectively.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (3)

Novo Nordisk Investigational Site

Princeton, New Jersey, 08540, United States

Location

Novo Nordisk Investigational Site

Madrid, Spain

Location

Novo Nordisk Investigational Site

London, United Kingdom

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834).

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 23, 2023
• Study Start: July 5, 2023
• Primary Completion (Estimated): October 31, 2032
• Study Completion (Estimated): December 30, 2032
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1); ES (1); GB (1)