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New study investigates Wegovy's safety in pregnancy
NCT ID NCT05503927
First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times
Summary
This study looks at health records of about 1,100 women who took Wegovy during pregnancy and compares them to those who did not. The goal is to see if the drug increases risks for birth defects or other problems in babies. Researchers will use insurance claims data to track outcomes like major birth defects and low birth weight.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 2,701 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2020
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Pregnant participants exposed to Wegovy injection and Wegovy tablet, other AOM and pregnant participants with obesity and overweight were observed.
- Ages
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15 to 50 years
- Sex
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Female participants only
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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IBM Watson Health™ Truven Marketscan
Ann Arbor, Michigan, 48108, United States
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Novo Nordisk Investigational Site
Princeton, New Jersey, 08540, United States
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