A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy

Part of paid clinical trials in Princeton, New Jersey.

Sponsor
Novo Nordisk A/S
Study ID
NCT05872022
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 50 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, prospective Wegovy (semaglutide 2.4 milligram \[mg\]) Pregnancy Registry Study. The aim of this study is to compare the maternal, foetal, and infant outcomes of pregnant women who are exposed to Wegovy during pregnancy for the treatment of obesity or overweight with at least one weight-related comorbid condition with outcomes in an internal comparison cohort of pregnant women with obesity or overweight with at least one weight related comorbid condition at conception and who are not exposed to Wegovy or other glucagon-like peptide-1 receptor agonists (GLP-1 RAs) during pregnancy. Infant outcomes will be assessed throughout the infant's first year of life, with active data collection by the registry occurring at 4 and 12 months after delivery.

Key Dates

Start date
Jul 5, 2023
Status verified
Jan 2026
Primary completion
Oct 31, 2032
Completion
Dec 30, 2032

Study Design

Enrollment
728 participants (estimated)

Arms

  • Arm: Participants Exposed to Wegovy
    Pregnant women who are exposed to Wegovy at any time during pregnancy for the treatment of obesity or overweight with at least one weight-related comorbid condition will be observed in this prospective observational study.
  • Arm: Participants Unexposed to Wegovy or Other GLP-1 RAs
    Pregnant women who have overweight with at least one weight-related comorbid condition or who have obesity at conception and who are not exposed to Wegovy or other GLP-1 RAs at any time during pregnancy but who may be exposed to other products for weight management will be observed in this prospective observational study.

Primary Outcome Measure

Number of Infants with Major Congenital Malformation (MCM) [ Time Frame: From date of conception (DOC) to pregnancy outcome for foetal losses or 12 months of infant age for live births ]

Locations (1)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SitePrincetonNew Jersey08540-

Find similar trials in Princeton, NJ

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Novo Nordisk Investigational Site· Princeton, NJ

Related Studies