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PregnancyNCT05503927

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

An observational study of Pregnancy and Obesity, run by Novo Nordisk A/S at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This is an observational 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… Read more about this study

Who is it for?
Ages 15 to 50 years, women only
Conditions the study is for
Pregnancy, Obesity, Overweight
How many people
2,701 participants
Where
2 sitesUnited States
Study dates
1 Feb 2020to 15 Aug 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 50 years
  • Women only
  • Child, Adult

Study population: Pregnant participants exposed to Wegovy injection and Wegovy tablet, other AOM and pregnant participants with obesity and overweight were observed.

Who may be able to join

  • 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.
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  • Wegovy injection-exposed- for greater than or equal to 1 day of Wegovy exposure from 35 days prior to estimated end of pregnancy.
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites

  • IBM Watson Health™ Truven Marketscan

    Ann Arbor, Michigan, 48108

  • Novo Nordisk Investigational Site

    Princeton, New Jersey, 08540

Other trials in United States

About this study

Official title: Wegovy® (Semaglutide) Database Study: A Population-based Cohort Study to Investigate Safety Outcomes of Exposure to Wegovy During Pregnancy

This is an observational 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.

Being tested
No Intervention
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No InterventionOther

    This is a non-interventional study, therefore no intervention is used.

Study groups in NCT05503927
Study groupRoleWhat they receive
Participants Exposed to Wegovy injection or Wegovy tabletPregnant participants exposed to Wegovy injection or Wegovy tablet during the first trimester (T1) (that is, 35 days prior to the estimated conception date through <14 weeks gestational age [wGA]) and their linked infants will be observed in this observational study.
Receives: Other: No Intervention
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 observational study.
Receives: Other: No Intervention
Overweight/Obese ParticipantsPregnant participants with obesity or overweight and at least one weight-related comorbid condition without exposure to Wegovy injection or tablet or other AOM during pregnancy will be observed in this observational study.
Receives: Other: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Infants with Major Congenital Malformation (MCM)

    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.

    Measured: Birth up to 1 year of age

Secondary outcomes (7)

  1. Number of Infants Experiencing Small for Gestational Age (SGA) Birth

    Number of infants experiencing small for gestational age is defined as weight at birth in less than (<) 10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants.

    Measured: Birth up to 1 year of age

  2. Number of infants with Developmental Delay

    Infant development delay will be defined as infants with evidence of one or more of the following outcomes in the first year of life: delayed milestone in childhood, other lack of normal physiological development, special screening for developmental disabilities.

    Measured: Birth up to 1 year of age

  3. Number of Infants With Postnatal Growth Deficiency

    Number of infants with adverse postnatal growth will be defined as infants with evidence of the following outcomes in the first year of life: abnormal weight gain (insufficient or excessive weight gain), short stature, failure to thrive.

    Measured: Birth up to 1 year of age

  4. Number of Pregnant Participants Experiencing Stillbirth

    Number of pregnant participants experiencing still birth is defined as an involuntary fetal loss occurring at greater than or equal to (>=20) WGA.

    Measured: up to 37 weeks of gestational age

  5. Number of Pregnant Participants Experiencing Spontaneous Abortion (SAB)

    Number of pregnant participants experiencing SAB is defined as an involuntary fetal loss or the expulsion of the products of conception occurring at <20 WGA.

    Measured: up to 37 weeks of gestational age

  6. Number of Pregnant Participants With Preterm Delivery

    Preterm birth is defined as a live birth occurring at <37 WGA.

    Measured: Up to 37 weeks of gestational age

  7. Number of Pregnant Participants With Pre-eclampsia/eclampsia

    Pre-eclampsia/eclampsia is defined as new onset of hypertension with proteinuria occurring at >=20WGA through the six weeks following pregnancy end.

    Measured: Up to 37 weeks of gestational age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2022
  2. Study start1 Feb 2020
  3. Primary completion15 Aug 2027 (estimated)
  4. Study completion15 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
2,701 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05503927
Sponsor's protocol ID
NN9536-4971
Other IDs
U1111-1273-4411
Status last verified
Jul 2026
First submitted
10 Aug 2022
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy and Obesity, run by Novo Nordisk A/S at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Infants with Major Congenital Malformation (MCM) (time frame: Birth up to 1 year of age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05503927.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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