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

• ClinicalTrials.gov Identifier: NCT05503927
• Recruitment Status: Enrolling by invitation
• First Posted: August 17, 2022
• Last Update Posted: November 9, 2023
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Tracking Information

• First Submitted Date: August 10, 2022
• First Posted Date: August 17, 2022
• Last Update Posted Date: November 9, 2023
• Actual Study Start Date: January 2, 2023
• Estimated Primary Completion Date: August 15, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 16, 2022)

Number of Infants with Major Congenital Malformation (MCM) [ Time Frame: Birth up to 1 year of age ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 16, 2022)

• Number of Infants Experiencing Small for Gestational Age (SGA) Birth [ Time Frame: Birth up to 1 year of age ]
  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.
• Number of infants with Developmental Delay [ Time Frame: Birth up to 1 year of age ]
  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.
• Number of Infants With Postnatal Growth Deficiency [ Time Frame: Birth up to 1 year of age ]
  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.
• Number of Pregnant Participants Experiencing Stillbirth [ Time Frame: up to 37 weeks of gestational age ]
  Number of pregnant participants experiencing still birth is defined as an involuntary fetal loss occurring at greater than or equal to (>=20) WGA.
• Number of Pregnant Participants Experiencing Spontaneous Abortion (SAB) [ Time Frame: up to 37 weeks of gestational age ]
  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.
• Number of Pregnant Participants With Preterm Delivery [ Time Frame: Up to 37 weeks of gestational age ]
  Preterm birth is defined as a live birth occurring at <37 WGA.
• Number of Pregnant Participants With Pre-eclampsia/eclampsia [ Time Frame: Up to 37 weeks of gestational age ]
  Pre-eclampsia/eclampsia is defined as new onset of hypertension with proteinuria occurring at >=20WGA through the six weeks following pregnancy end.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Safety of Exposure to Wegovy During Pregnancy
• Official Title: Wegovy® (Semaglutide 2.4 mg) Database Study: A Population-based Cohort Study to Investigate Safety Outcomes of Exposure to Wegovy During Pregnancy
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Pregnant participants exposed to Wegovy, other AOM and pregnant participants with obesity and overweight were observed retrospectively.

Condition

• Pregnancy
• Obesity
• Overweight

Intervention

Other: No Intervention

This is a non-interventional study, therefore no intervention is used.

Study Groups/Cohorts

• Participants Exposed to Wegovy
  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.
  Intervention: Other: No Intervention
• Participants Exposed to Anti-obesity Medication (AOM)
  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.
  Intervention: Other: No Intervention
• Overweight/Obese Participants
  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.
  Intervention: Other: No Intervention

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: August 16, 2022): 1139
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 15, 2027
• Estimated Primary Completion Date: August 15, 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: This is a study of prenatal exposure to Wegovy in pregnant women.

• Ages: 15 Years to 45 Years (Child, Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05503927
• Other Study ID Numbers: NN9536-4971; U1111-1273-4411 ( Other Identifier: World Health Organization (WHO) )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
• URL: http://novonordisk-trials.com

• Current Responsible Party: Novo Nordisk A/S
• Original Responsible Party: Same as current
• Current Study Sponsor: Novo Nordisk A/S
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: (dept. 2834); Novo Nordisk A/S

• PRS Account: Novo Nordisk A/S
• Verification Date: October 2023