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Enrolling by Invitation

NCT Number: NCT05872022

A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy

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.

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Key information

Conditions

Pregnancy Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

15 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Madrid, Spain

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. Number of Infants with Major Congenital Malformation (MCM)

    Time frame: 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.

Secondary outcomes

  1. Number of Infants with Minor Congenital Malformation

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

    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.

  2. Number of Pregnant Participants With Pre-eclampsia

    Time frame: From 20 0/7 gestational weeks to 6 weeks

    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.

  3. Number of Pregnant Participants With Eclampsia

    Time frame: From 20 0/7 gestational weeks to 6 weeks

    Eclampsia is defined as seizures or coma in a woman with pre-eclampsia during pregnancy through 6 weeks postpartum.

  4. Number of Pregnant Participants Experiencing Spontaneous Abortion

    Time frame: From date of conception to 19 6/7 gestational weeks

    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.

  5. Number of Pregnant Participants Experiencing Stillbirth

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

    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.

  6. Number of Pregnant Participants With Elective Termination

    Time frame: From date of conception to pregnancy outcome (week 40)

    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.

  7. Number of Pregnant Participants With Preterm Delivery

    Time frame: From date of conception to 37 gestational weeks (week 37)

    Preterm birth is defined as a live birth occurring at <37 gestational weeks.

  8. Number of Infants Experiencing Small for Gestational Age (SGA) Birth

    Time frame: At delivery of live 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.

  9. Number of Infants With Postnatal Growth Deficiency

    Time frame: At 4 and 12 months of infant age

    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.

  10. Number of infants with Developmental Delay

    Time frame: At 4 and 12 months of infant age

    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).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2032
Study completion
2032
First posted
May 23, 2023
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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