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

NCT05503927 | Enrolling By Invitation DMC

• 2 other identifiers: NN9536-4971U1111-1273-4411
• Study Type: observational
• Target: 1,139
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational, retrospective, 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.

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.

  Birth up to 1 year of age

Secondary Outcomes (7)

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

  Birth up to 1 year of age

• Number of infants with Developmental Delay

  Birth up to 1 year of age

• Number of Infants With Postnatal Growth Deficiency

  Birth up to 1 year of age

• Number of Pregnant Participants Experiencing Stillbirth

  up to 37 weeks of gestational age

• Number of Pregnant Participants Experiencing Spontaneous Abortion (SAB)

  up to 37 weeks of gestational age

Study Arms (3)

Participants Exposed to Wegovy

Pregnant participants exposed to Wegovy during the first trimester (T1) (that is, estimated conception date - 35 days through \<14 weeks gestational age \[WGA\]) and their linked infants will be observed in this retrospective observational study.

Other: No Intervention

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 retrospective observational study.

Other: No Intervention

Overweight/Obese Participants

Pregnant participants with obesity or overweight and 1 or more comorbid condition without exposure to Wegovy or other AOM during pregnancy will be observed in this retrospective observational study.

Other: No Intervention

Interventions

No Intervention OTHER

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

Overweight/Obese Participants; Participants Exposed to Anti-obesity Medication (AOM); Participants Exposed to Wegovy

Eligibility Criteria

• Age: 15 Years - 45 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, other AOM and pregnant participants with obesity and overweight were observed retrospectively.

You may qualify if:

• 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 2027).
• Aged 15-45 and female on the date of the last menstrual period (LMP).
• Continuous enrolment in the database with medical and pharmacy benefits for at least 6 months prior to the date of LMP through 42 days after the pregnancy end date.
• Wegovy-exposed- for greater than or equal to 1 day of Wegovy exposure from estimated conception date (LMP +14) - 35 days to 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 estimated conception date-1 day to end of pregnancy.
• Phentermine or bupropion/naltrexone exposure from estimated conception date- 5 days to end of pregnancy.
• Cohort with Overweight/Obesity-
• 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.

You may not qualify if:

• Pregnancies exposed to other glucagon-like peptide-1 receptor agonist (GLP-1 RA) during the exposure identification window (estimated conception date - 35 days 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Princeton, New Jersey, 08540, United States

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

• (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 17, 2022
• Study Start: January 2, 2023
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)