PregnancyNCT05872022
A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy
An observational study of Pregnancy and Obesity, run by Novo Nordisk A/S at 3 sites in 3 countries.
Trial summary
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… 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
- 728 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 5 Jul 2023to 30 Dec 2032
- 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 during pregnancy, and pregnant participants who were 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 with obesity and overweight were to be observed prospectively.
Who may be able to join
- Signed consent obtained before any study-related activities
- Female 15-50 years of age at the time of signing consent
- Currently or recently pregnant
- Resident of country included in the study
- Authorisation for her HCP(s) to provide data to the registry
- Exposed to Wegovy cohort: Exposure to at least one dose of Wegovy at any time during pregnancy for the treatment of obesity or overweight with at least one weight-related comorbid condition.
- Unexposed to Wegovy cohort: Have obesity or overweight with at least one weight related comorbid condition at conception
Who cannot join
- Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation
- Unexposed to Wegovy cohort: Exposure to Wegovy or other GLP-1 RA at any time during pregnancy
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
United States1 site
Novo Nordisk Investigational Site
Princeton, New Jersey, 08540
About this study
Official title: Wegovy® (Semaglutide 2.4 mg) Pregnancy Registry Study: A Prospective Cohort Study to Investigate Safety Outcomes of Exposure to Wegovy During Pregnancy
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.
- Conditions
- Pregnancy, Obesity, Overweight
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Intervention | |
| 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: From date of conception (DOC) to pregnancy outcome for foetal losses or 12 months of infant age for live births
Secondary outcomes (10)
Number of Infants with Minor Congenital Malformation
Number of infants with minor congenital malformation is defined as an anomaly or abnormality of body structure that is present at birth, is of prenatal origin (that is, birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual.
Measured: From DOC to pregnancy outcome for foetal losses or 12 months of infant age for live births
Number of Pregnant Participants With Pre-eclampsia
Number of pregnant participants with pre-eclampsia is defined as pregnant participants with high blood pressure and signs of liver or kidney damage occurring at greater than (>) 20 gestational weeks through 6 weeks postpartum.
Measured: From 20 0/7 gestational weeks to 6 weeks
Number of Pregnant Participants With Eclampsia
Eclampsia is defined as seizures or coma in a woman with pre-eclampsia during pregnancy through 6 weeks postpartum.
Measured: From 20 0/7 gestational weeks to 6 weeks
Number of Pregnant Participants Experiencing Spontaneous Abortion
Number of pregnant participants experiencing spontaneous abortion is defined as an involuntary foetal loss or the expulsion of the products of conception occurring at less than (<) 20 gestational weeks.
Measured: From date of conception to 19 6/7 gestational weeks
Number of Pregnant Participants Experiencing Stillbirth
Number of pregnant participants experiencing still birth is defined by the American College of Obstetricians and Gynecologists (ACOG), an involuntary foetal loss occurring at greater than or equal to (>=)20 gestational weeks or, if gestational age is unknown, a foetus weighing >=350 gram.
Measured: From 20 0/7 gestational weeks to pregnancy outcome (week 40)
Number of Pregnant Participants With Elective Termination
Number of pregnant participants with elective termination is defined as a voluntary foetal loss or interruption of pregnancy that occurs for any reason, including but not limited to for the preservation of maternal health or due to foetal abnormalities.
Measured: From date of conception to pregnancy outcome (week 40)
Number of Pregnant Participants With Preterm Delivery
Preterm birth is defined as a live birth occurring at <37 gestational weeks.
Measured: From date of conception to 37 gestational weeks (week 37)
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 <10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants.
Measured: At delivery of live birth
Number of Infants With Postnatal Growth Deficiency
Number of infants with postnatal growth deficiency is defined as infants with weight, length, or head circumference in <10th percentile for sex and age using standard growth charts.
Measured: At 4 and 12 months of infant age
Number of infants with Developmental Delay
Infant development delay is defined as infants with failure to achieve the developmental milestones for age, as defined by the Centers for Disease Control and Prevention (CDC).
Measured: At 4 and 12 months of infant age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start5 Jul 2023
- Primary completion31 Oct 2032 (estimated)
- Study completion30 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 728 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834)., Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872022
- Sponsor's protocol ID
- NN9536-4937
- Other IDs
- U1111-1273-4336
- Status last verified
- Jan 2026
- First submitted
- 26 Apr 2023
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on NovoNordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wegovy® (Semaglutide 2.4 mg) Pregnancy Registry Study: A Prospective Cohort Study to Investigate Safety Outcomes of Exposure to Wegovy During Pregnancy
- ClinicalTrials.gov ID
- NCT05872022
- Acronym / sponsor ID
- NN9536-4937
- Conditions
- Pregnancy, Obesity, Overweight
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 728 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 31 Oct 2032 (estimated)
- Study completion
- 30 Dec 2032 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants Exposed to Wegovy | – | Other: No InterventionPregnant 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. |
| Participants Unexposed to Wegovy or Other GLP-1 RAs | – | Other: No InterventionPregnant 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. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Pregnant participants exposed to Wegovy during pregnancy, and pregnant participants who were 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 with obesity and overweight were to be observed prospectively.
Key inclusion criteria (7 listed)
- Signed consent obtained before any study-related activities
- Female 15-50 years of age at the time of signing consent
- Currently or recently pregnant
- Resident of country included in the study
- Authorisation for her HCP(s) to provide data to the registry
Key exclusion criteria (2 listed)
- Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation
- Unexposed to Wegovy cohort: Exposure to Wegovy or other GLP-1 RA at any time during pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is a non-interventional study, therefore no intervention is used. | Other | Participants Exposed to Wegovy, Participants Unexposed to Wegovy or Other GLP-1 RAs |
Primary outcome
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
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.
10 secondary outcomes
Number of Infants with Minor Congenital Malformation
Time frame: From DOC to pregnancy outcome for foetal losses or 12 months of infant age for live births
Number of Pregnant Participants With Pre-eclampsia
Time frame: From 20 0/7 gestational weeks to 6 weeks
Number of Pregnant Participants With Eclampsia
Time frame: From 20 0/7 gestational weeks to 6 weeks
Number of Pregnant Participants Experiencing Spontaneous Abortion
Time frame: From date of conception to 19 6/7 gestational weeks
Number of Pregnant Participants Experiencing Stillbirth
Time frame: From 20 0/7 gestational weeks to pregnancy outcome (week 40)
Number of Pregnant Participants With Elective Termination
Time frame: From date of conception to pregnancy outcome (week 40)
Number of Pregnant Participants With Preterm Delivery
Time frame: From date of conception to 37 gestational weeks (week 37)
Number of Infants Experiencing Small for Gestational Age (SGA) Birth
Time frame: At delivery of live birth
Number of Infants With Postnatal Growth Deficiency
Time frame: At 4 and 12 months of infant age
Number of infants with Developmental Delay
Time frame: At 4 and 12 months of infant age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on NovoNordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency (dept. 2834). study director
Novo Nordisk A/S
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Obesity, run by Novo Nordisk A/S at 3 sites in 3 countries.
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 7 inclusion and 2 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 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Spain, United Kingdom. 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: From date of conception (DOC) to pregnancy outcome for foetal losses or 12 months of infant age for live births). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2026.