A Study to Evaluate the Safety of Exposure to Wegovy During Pregnancy

Wegovy® (Semaglutide) Database Study: A Population-based Cohort Study to Investigate Safety Outcomes of Exposure to Wegovy During Pregnancy

This is an observational cohort study using administrative insurance claims data. The aim of this non-interventional study (NIS) is to compare maternal, fetal and infant outcomes of women exposed to Wegovy during pregnancy to a reference population not exposed to Wegovy, so that participants and healthcare providers can make informed treatment decisions.

Study Overview

• Status: Enrolling by invitation
• Conditions: Obesity; Overweight; Pregnancy
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Estimated): 2701

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • IBM Watson Health™ Truven Marketscan
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Pregnant participants exposed to Wegovy injection and Wegovy tablet, other AOM and pregnant participants with obesity and overweight were observed.

Description

Inclusion Criteria:

• Evidence of a pregnancy end event on a medical claim (example, live birth, stillbirth, or spontaneous abortion) during the pregnancy identification period (that is, 04 June 2021 - 17 February 2034).
• Date of conception between 04 June 2021 and 06 May 2033 (that is last menstrual period (LMP) 43 weeks prior to the latest pregnancy end date).
• Aged 15-50 and female on the date of the LMP.
• Continuous enrolment in the database with medical and pharmacy benefits for at least 6 months prior to the date of conception through 42 days after the pregnancy end date.
• Among the pregnancies that meet the inclusion criteria, four main cohorts and two sub cohorts of interest will be identified (two Wegovy-exposed cohorts and two comparison cohorts):

• Wegovy-exposed- for greater than or equal to 1 day of Wegovy exposure from 35 days prior to estimated date of conception to end of pregnancy. Two mutually exclusive cohorts will be identified based on first Wegovy exposure during pregnancy.

  1. Wegovy injection-exposed- for greater than or equal to 1 day of Wegovy exposure from 35 days prior to estimated end of pregnancy.
  2. Wegovy tablet-exposed- for greater than or equal to 1 day of Wegovy exposure from 35 days prior to estimated end of pregnancy.
• Other AOM-exposed- greater than or equal to1 day of phentermine, diethylpropion, benzphetamine, phendimetrazine, orlistat, or bupropion/naltrexone exposure, defined as the following:
• Benzphetamine, diethylpropion, orlistat, or phendimetrazine exposure from one day prior to estimated conception date to end of pregnancy.
• Phentermine or bupropion/naltrexone exposure from five days prior to estimated conception date to end of pregnancy.
• Cohort with Overweight/Obesity and at least one weight related comorbid condition-
• Greater than or equal to 1 diagnosis code for obesity or BMI greater than or equal to 30 kilogram per meter square (kg/m^2) on a medical claim during the six month pre-pregnancy period.
• Greater than or equal to 1 diagnosis code for BMI greater than or equal to 27 kg/m^2 or less than 30 kg/m^2 on a medical claim and greater than or equal to 1 non-diagnostic medical claim for dyslipidemia, type 2 diabetes mellitus, or hypertension during the six month pre-pregnancy period.
• No exposure to Wegovy or other AOM during the defined exposure window in pregnancy.
• Among Wegovy-exposed and Other AOM-exposed pregnancies, the subset with first trimester exposures will be identified as those with greater than or equal to 1 days of exposure at less than 14 WGA.

Exclusion Criteria:

• Pregnancies exposed to other glucagon-like peptide-1 receptor agonist (GLP-1 RA) during the exposure identification window (that is, 35 days prior to estimated conception date through pregnancy end date).
• Pregnancies with exposure to both Wegovy and other AOM during the exposure identification window (estimated conception date - 35 days through pregnancy end date).
• Pregnancies resulting in multiple infants will be excluded from the analysis of infant outcomes.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants Exposed to Wegovy injection or Wegovy tablet; Pregnant participants exposed to Wegovy injection or Wegovy tablet during the first trimester (T1) (that is, 35 days prior to the estimated conception date through <14 weeks gestational age [wGA]) and their linked infants will be observed in this observational study.	Other: No Intervention; This is a non-interventional study, therefore no intervention is used.
Participants Exposed to Anti-obesity Medication (AOM); Pregnant participants exposed to other Anti-obesity Medication (AOM) (phentermine, diethylpropion, benzphetamine, phendimetrazine, orlistat, or bupropion/naltrexone) during the first trimester (start of exposure identification window based on five times the half-life of each AOM through <14 WGA) and their linked infants will be observed in this observational study.	Other: No Intervention; This is a non-interventional study, therefore no intervention is used.
Overweight/Obese Participants; Pregnant participants with obesity or overweight and at least one weight-related comorbid condition without exposure to Wegovy injection or tablet or other AOM during pregnancy will be observed in this observational study.	Other: No Intervention; This is a non-interventional study, therefore no intervention is used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Birth up to 1 year of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 less than (<) 10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants.	Birth up to 1 year of age
Number of infants with Developmental Delay	Infant development delay will be defined as infants with evidence of one or more of the following outcomes in the first year of life: delayed milestone in childhood, other lack of normal physiological development, special screening for developmental disabilities.	Birth up to 1 year of age
Number of Infants With Postnatal Growth Deficiency	Number of infants with adverse postnatal growth will be defined as infants with evidence of the following outcomes in the first year of life: abnormal weight gain (insufficient or excessive weight gain), short stature, failure to thrive.	Birth up to 1 year of age
Number of Pregnant Participants Experiencing Stillbirth	Number of pregnant participants experiencing still birth is defined as an involuntary fetal loss occurring at greater than or equal to (>=20) WGA.	up to 37 weeks of gestational age
Number of Pregnant Participants Experiencing Spontaneous Abortion (SAB)	Number of pregnant participants experiencing SAB is defined as an involuntary fetal loss or the expulsion of the products of conception occurring at <20 WGA.	up to 37 weeks of gestational age
Number of Pregnant Participants With Preterm Delivery	Preterm birth is defined as a live birth occurring at <37 WGA.	Up to 37 weeks of gestational age
Number of Pregnant Participants With Pre-eclampsia/eclampsia	Pre-eclampsia/eclampsia is defined as new onset of hypertension with proteinuria occurring at >=20WGA through the six weeks following pregnancy end.	Up to 37 weeks of gestational age

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 15, 2027

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: NN9536-4971; U1111-1273-4411 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No