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Semaglutide 2023-07-05 ClinicalTrials

Wegovy Pregnancy Registry to evaluate maternal, fetal, and infant safety outcomes in exposed women

A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy

Background

Obesity and type 2 diabetes are increasingly managed with GLP-1 receptor agonists (GLP-1RAs) like semaglutide, particularly among women of reproductive age. While effective, emerging evidence from prior studies suggests potential risks during pregnancy, including higher adjusted odds ratios for excessive gestational weight gain (aOR=1.98), gestational diabetes (aOR=1.43), excessive fetal growth (aOR=1.54), and cesarean delivery (aOR=3.92) in former GLP-1RA users. This raises critical safety questions for continued use or inadvertent exposure during pregnancy, highlighting a significant gap in real-world safety data for Wegovy.

Study Design

This is an observational, prospective Wegovy (semaglutide 2.4 mg) Pregnancy Registry Study. The study aims to compare maternal, fetal, and infant outcomes in pregnant women exposed to Wegovy during pregnancy for obesity or overweight with at least one weight-related comorbid condition. An internal comparison cohort of pregnant women with similar baseline characteristics but unexposed to Wegovy or other GLP-1 RAs during pregnancy will serve as controls. Infant outcomes will be assessed throughout the first year of life, with active data collection by the registry occurring at 4 and 12 months after delivery.

Results

This abstract describes the design of an ongoing observational registry. It does not present any current findings or outcomes regarding Wegovy exposure during pregnancy. The study aims to collect and compare maternal, fetal, and infant outcomes between exposed and unexposed cohorts, with data collection planned at 4 and 12 months post-delivery for infants. The registry's primary goal is to generate real-world safety data to inform clinical practice.

Why It Matters

Wegovy (semaglutide) is a highly effective treatment for obesity, and its increasing use among women of reproductive age makes robust pregnancy safety data critically important. This prospective registry aims to fill a significant knowledge gap by providing real-world evidence on maternal, fetal, and infant outcomes following exposure. Currently, clinical guidelines generally recommend discontinuing GLP-1RAs prior to or upon confirmation of pregnancy due to limited human data and animal studies showing potential risks. The findings from this registry will be crucial for informing clinical counseling and updating prescribing recommendations for semaglutide in women who may become pregnant or are inadvertently exposed. This data will directly impact patient care, potentially allowing for more individualized risk-benefit assessments and clarifying whether specific protocols for managing GLP-1RA use around conception or early pregnancy are warranted. Without this evidence, clinicians and patients face uncertainty regarding the safety profile of a widely used medication during a vulnerable period.


semaglutide wegovy pregnancy safety obesity glp-1-agonist
Source: clinicaltrials:NCT05872022 · Ingested 2026-06-16 · Digest: gemini-2.5-flash