GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT05872022

Enrolling by invitation

A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy

Wegovy® (Semaglutide 2.4 mg) Pregnancy Registry Study: A Prospective 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

—

Enrollment

728

estimated

Study population

Obesity / overweight

Key I/E criterion

•Female

Primary endpoint

•Number of Infants with Major Congenital Malformation (MCM)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05872022

Org study IDNN9536-4937

Secondary IDU1111-1273-4336World Health Organization (WHO)

Timeline

Milestones

Study first posted2023-05-23actual

Study start2023-07-05actual

Last update posted2026-01-14actual

Primary completion2032-10-31estimated

Study completion2032-12-30estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age15 Years

Maximum age50 Years

SexFemale

Sampling methodNon probability sample

Study population text

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.

Inclusion criteria

•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

Exclusion criteria

•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

Endpoints (11)

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

5 endpoints

Primary/protocol endpoint

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

event count, event

Secondary/protocol endpoint

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

event count, event

Secondary/protocol endpoint

Number of Pregnant Participants With Eclampsia

Time frame:From 20 0/7 gestational weeks to 6 weeks

event count, event

Secondary/protocol endpoint

Number of Pregnant Participants Experiencing Spontaneous Abortion

Time frame:From date of conception to 19 6/7 gestational weeks

event count, event

Secondary/protocol endpoint

Number of Pregnant Participants With Elective Termination

Time frame:From date of conception to pregnancy outcome (week 40)

event count, event

Other clinical outcomes

6 endpoints

Secondary/protocol endpoint

Number of Pregnant Participants With Pre-eclampsia

Time frame:From 20 0/7 gestational weeks to 6 weeks

event count, event

Secondary/protocol endpoint

Number of Pregnant Participants Experiencing Stillbirth

Time frame:From 20 0/7 gestational weeks to pregnancy outcome (week 40)

event count, event

Secondary/protocol endpoint

Number of Pregnant Participants With Preterm Delivery

Time frame:From date of conception to 37 gestational weeks (week 37)

event count, event

Secondary/protocol endpoint

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

Time frame:At delivery of live birth

event count, event

Secondary/protocol endpoint/low confidence

Number of Infants With Postnatal Growth Deficiency

Time frame:At 4 and 12 months of infant age

threshold achievement, event

componentsweight percentile lt10, length percentile lt10, head circumference percentile lt10

Secondary/protocol endpoint

Number of infants with Developmental Delay

Time frame:At 4 and 12 months of infant age

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 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 1, 2026 snapshot.