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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05503927
• Other study ID #: NN9536-4971
• Secondary ID: U1111-1273-4411
• Status: Enrolling by invitation
• Start date: January 2, 2023
• Est. completion date: August 15, 2027

Study information

• Verified date: October 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational, retrospective, 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1139
• Est. completion date: August 15, 2027
• Est. primary completion date: August 15, 2027
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Pregnancy

Intervention

Other:
• No Intervention
This is a non-interventional study, therefore no intervention is used.

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Birth up to 1 year of age
Secondary	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.	Birth up to 1 year of age
Secondary	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.	Birth up to 1 year of age
Secondary	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.	Birth up to 1 year of age
Secondary	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.	up to 37 weeks of gestational age
Secondary	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.	up to 37 weeks of gestational age
Secondary	Number of Pregnant Participants With Preterm Delivery	Preterm birth is defined as a live birth occurring at <37 WGA.	Up to 37 weeks of gestational age
Secondary	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.	Up to 37 weeks of gestational age