Enrolling by invitation

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

Wegovy® (Semaglutide 2.4 mg) Database Study: A Population-based Cohort Study to Investigate Safety Outcomes of Exposure to Wegovy During Pregnancy

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

1,139

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥30•Female

Primary endpoint

•Number of Infants with Major Congenital Malformation (MCM)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05503927

Org study IDNN9536-4971

Secondary IDU1111-1273-4411World Health Organization (WHO)

Timeline

Milestones

Study first posted2022-08-17actual

Study start2023-01-02actual

Last update posted2026-01-14actual

Primary completion2027-08-15estimated

Study completion2027-08-15estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age15 Years

Maximum age45 Years

SexFemale

Sampling methodNon probability sample

Study population text

Pregnant participants exposed to Wegovy, other AOM and pregnant participants with obesity and overweight were observed retrospectively.

Inclusion criteria

•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 2027).

•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.

•Among the pregnancies that meet the inclusion criteria, three main cohorts of interest and two sub cohorts will be identified (one Wegovy-exposed cohort and two comparison cohorts):

•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 exposed to other glucagon-like peptide-1 receptor agonist (GLP-1 RA) during the exposure identification window (estimated conception date - 35 days 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.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Number of Infants with Major Congenital Malformation (MCM)

Time frame:Birth up to 1 year of age

event count, event

Secondary/protocol endpoint

Number of Pregnant Participants Experiencing Spontaneous Abortion (SAB)

Time frame:up to 37 weeks of gestational age

event count, event

Other clinical outcomes

6 endpoints

Secondary/protocol endpoint

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

Time frame:Birth up to 1 year of age

threshold achievement, event

Secondary/protocol endpoint

Number of infants with Developmental Delay

Time frame:Birth up to 1 year of age

event count, event

Secondary/protocol endpoint/low confidence

Number of Infants With Postnatal Growth Deficiency

Time frame:Birth up to 1 year of age

threshold achievement, event

componentsabnormal weight gain, short stature, failure to thrive

Secondary/protocol endpoint

Number of Pregnant Participants Experiencing Stillbirth

Time frame:up to 37 weeks of gestational age

event count, event

Secondary/protocol endpoint

Number of Pregnant Participants With Preterm Delivery

Time frame:Up to 37 weeks of gestational age

event count, event

Secondary/protocol endpoint

Number of Pregnant Participants With Pre-eclampsia/eclampsia

Time frame:Up to 37 weeks of gestational age

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.