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

Novo Nordisk

Status: Invitation-only

Conditions: Overweight; Obesity; Pregnancy

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT05503927

U1111-1273-4411 (Other Identifier)

NN9536-4971

Details and patient eligibility

About

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.

Enrollment: 1,139 estimated patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,139 participants in 3 patient groups

Participants Exposed to Wegovy

Description:

Pregnant participants exposed to Wegovy during the first trimester (T1) (that is, estimated conception date - 35 days through \<14 weeks gestational age \[WGA\]) and their linked infants will be observed in this retrospective observational study.

Treatment:

Other: No Intervention

Participants Exposed to Anti-obesity Medication (AOM)

Description:

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 retrospective observational study.

Treatment:

Other: No Intervention

Overweight/Obese Participants

Description:

Pregnant participants with obesity or overweight and 1 or more comorbid condition without exposure to Wegovy or other AOM during pregnancy will be observed in this retrospective observational study.

Treatment:

Other: No Intervention