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Observational Study of Wegovy During Pregnancy

This study is looking at the safety of Wegovy during pregnancy. Researchers want to compare the health of mothers and babies exposed to Wegovy during pregnancy with those who were not. They will do this by looking at existing health insurance claims data. The main goal is to see how many babies are born with major birth defects (congenital malformations) up to one year after birth. You might be able to join if you are a woman between 15 and 50 years old, have been pregnant, and your pregnancy ended between June 4, 2021, and February 17, 2034. The study is currently unclear on its recruitment status and plans to include 2701 participants.

Study design
This is an observational study, meaning researchers will look at existing health records rather than giving participants a treatment. It aims to include 2701 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track the number of infants with major birth defects from birth up to 1 year of age.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05503927

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

Enrolling by Invitation
Not specifiedAges 15–50Observational
Novo Nordisk A/S
~2,701 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:No Intervention

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Infants with Major Congenital Malformation (MCM)
Measured over Birth up to 1 year of age

Conditions

Pregnancy
Obesity
Overweight

Explore related trials

ObesityOverweightPregnancy

Where it's being run

2 sites across 2 states
Michigan1
New Jersey1

Study leadership

  • (dept. 2834) · STUDY_DIRECTOR · Novo Nordisk A/S

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.
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

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.

What this trial measures

  • Number of Infants with Major Congenital Malformation (MCM)Birth up to 1 year of age

    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.