A Study to Evaluate the Safety of Exposure to Wegovy During Pregnancy
NCT ID: NCT05503927
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
1139 participants
OBSERVATIONAL
2023-01-02
2027-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
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 retrospective observational study.
No Intervention
This is a non-interventional study, therefore no intervention is used.
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.
No Intervention
This is a non-interventional study, therefore no intervention is used.
Interventions
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No Intervention
This is a non-interventional study, therefore no intervention is used.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
15 Years
45 Years
FEMALE
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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(dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Princeton, New Jersey, United States
Countries
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Other Identifiers
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U1111-1273-4411
Identifier Type: OTHER
Identifier Source: secondary_id
NN9536-4971
Identifier Type: -
Identifier Source: org_study_id