Wegovy Pregnancy Registry
Research type
Research Study
Full title
Wegovy® (semaglutide 2.4 mg) Pregnancy Registry Study: A Prospective Cohort Study to Investigate Safety Outcomes of Exposure to Wegovy during Pregnancy
IRAS ID
347411
Contact name
Tricia Tan
Contact email
Sponsor organisation
Novo Nordisk
Duration of Study in the UK
6 years, 11 months, 13 days
Research summary
The Wegovy Pregnancy Registry is a non-interventional study with the aim to compare maternal, foetal and infant outcomes between women exposed to Wegovy (semaglutide 2.4mg) during pregnancy and an unexposed reference population. This is a post-authorisation safety study (PASS).
Wegovy is approved to be used alongside a reduced calorie diet and increased physical activity for chronic weight management in adults with a body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) with at least one weight-related condition.
The registry aims to enrol a total of 728 pregnant women in the study population across sites in the United States, United Kingdom and Spain, with 364 women aged 15-50 years in two groups. The ‘exposed’ group will include pregnant women who were obese or overweight with at least one weight-related condition and were exposed to Wegovy at any time during pregnancy. The ‘unexposed’ group will include pregnant women who were obese or overweight with at least one weight-related condition and who were not exposed to Wegovy or a similar drug during pregnancy, but may be exposed to other products for weight management.
Pregnancy outcomes will be assessed through data collection at enrolment, week 26 of pregnancy, and at delivery. Infant outcomes will be assessed through data collection at 4 and 12 months after delivery. Enrolled pregnant women and the healthcare providers in their care and that of their infants will serve as data reporters for the registry.
Data collection is planned for approximately 10 years, or until the target sample size is met.
REC name
West of Scotland REC 5
REC reference
25/WS/0106
Date of REC Opinion
12 Aug 2025
REC opinion
Further Information Favourable Opinion