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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Novo Nordisk A/S
Study ID
NCT05503927
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • No Intervention — OTHER
    This is a non-interventional study, therefore no intervention is used.

Study Details

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.

Key Dates

Start date
Feb 1, 2020
Status verified
Jun 2026
Primary completion
Aug 15, 2027
Completion
Aug 15, 2027

Study Design

Enrollment
1,139 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Number of Infants with Major Congenital Malformation (MCM) [ Time Frame: Birth up to 1 year of age ]

Locations (2)

FacilityCityStateZIPSite coordinators
IBM Watson Health™ Truven MarketscanAnn ArborMichigan48108-
Novo Nordisk Investigational SitePrincetonNew Jersey08540-

Find similar trials in Ann Arbor, MI

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
IBM Watson Health™ Truven Marketscan· Ann Arbor, MINovo Nordisk Investigational Site· Princeton, NJ

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