A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy

Obesity Clinical Trial

Official title:

Wegovy® (Semaglutide 2.4 mg) Pregnancy Registry Study: A Prospective Cohort Study to Investigate Safety Outcomes of Exposure to Wegovy During Pregnancy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05872022
• Other study ID #: NN9536-4937
• Secondary ID: U1111-1273-4336
• Status: Enrolling by invitation
• Start date: July 5, 2023
• Est. completion date: December 30, 2032

Study information

• Verified date: October 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 728
• Est. completion date: December 30, 2032
• Est. primary completion date: October 31, 2032
• Gender: Female
• Age group: 15 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Pregnancy

Intervention

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

Locations

Country	Name	City	State
Spain	Novo Nordisk Investigational Site	Madrid
United Kingdom	Novo Nordisk Investigational Site	London
United States	Novo Nordisk Investigational Site	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Infants with Minor Congenital Malformation	Number of infants with minor congenital malformation is defined as an anomaly or abnormality of body structure that is present at birth, is of prenatal origin (that is, birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual.	From DOC to pregnancy outcome for foetal losses or 12 months of infant age for live births
Secondary	Number of Pregnant Participants With Pre-eclampsia	Number of pregnant participants with pre-eclampsia is defined as pregnant participants with high blood pressure and signs of liver or kidney damage occurring at greater than (>) 20 gestational weeks through 6 weeks postpartum.	From 20 0/7 gestational weeks to 6 weeks
Secondary	Number of Pregnant Participants With Eclampsia	Eclampsia is defined as seizures or coma in a woman with pre-eclampsia during pregnancy through 6 weeks postpartum.	From 20 0/7 gestational weeks to 6 weeks
Secondary	Number of Pregnant Participants Experiencing Spontaneous Abortion	Number of pregnant participants experiencing spontaneous abortion is defined as an involuntary foetal loss or the expulsion of the products of conception occurring at less than (<) 20 gestational weeks.	From date of conception to 19 6/7 gestational weeks
Secondary	Number of Pregnant Participants Experiencing Stillbirth	Number of pregnant participants experiencing still birth is defined by the American College of Obstetricians and Gynecologists (ACOG), an involuntary foetal loss occurring at greater than or equal to (>=)20 gestational weeks or, if gestational age is unknown, a foetus weighing >=350 gram.	From 20 0/7 gestational weeks to pregnancy outcome (week 40)
Secondary	Number of Pregnant Participants With Elective Termination	Number of pregnant participants with elective termination is defined as a voluntary foetal loss or interruption of pregnancy that occurs for any reason, including but not limited to for the preservation of maternal health or due to foetal abnormalities.	From date of conception to pregnancy outcome (week 40)
Secondary	Number of Pregnant Participants With Preterm Delivery	Preterm birth is defined as a live birth occurring at <37 gestational weeks.	From date of conception to 37 gestational weeks (week 37)
Secondary	Number of Infants Experiencing Small for Gestational Age (SGA) Birth	Number of infants experiencing small for gestational age is defined as weight at birth in <10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants.	At delivery of live birth
Secondary	Number of Infants With Postnatal Growth Deficiency	Number of infants with postnatal growth deficiency is defined as infants with weight, length, or head circumference in <10th percentile for sex and age using standard growth charts.	At 4 and 12 months of infant age
Secondary	Number of infants with Developmental Delay	Infant development delay is defined as infants with failure to achieve the developmental milestones for age, as defined by the Centers for Disease Control and Prevention (CDC).	At 4 and 12 months of infant age