Gestational diabetes & diabetes in pregnancy

Glucagon‐like peptide 1 ( GLP ‐1) receptor agonists' use during pregnancy: Safety data from regulatory clinical trials

Diabetes Obes MetabPublished Review of regulatory documentation from clinical trials

Authors' conclusion

Key knowledge gaps must be addressed before the introduction of the Glucagon-like peptide-1 receptor agonist class of drugs for pregnant women. Currently, Glucagon-like peptide-1 receptor agonists should be stopped as soon as the patient becomes aware of a pregnancy. The establishment of patient registries designed to capture data relating to cases of Glucagon-like peptide-1 receptor agonist exposure during pregnancy is a high priority, and where data already exist, the findings need to be published.

Study context

Population
Women with unplanned pregnancies during regulatory clinical trials of GLP-1 RA submitted to the FDA and EMA
Outcome
Outcomes of unplanned pregnancies during GLP-1 RA regulatory clinical trials
Methodological detailsFDA and EMA regulatory documents, FDA CDER Clinical and Medical Reviews before market authorisation
  • FDA and EMA regulatory documents
  • FDA CDER Clinical and Medical Reviews before market authorisation

Main finding

As reported in the abstract

Congenital abnormalities after GLP-1 RA use during pregnancy
  • Incidence of congenital abnormalities in humans appears relatively low after GLP-1 RA use during pregnancy
  • No evidence in planned pregnancies; only evidence is from pregnancies occurring inadvertently during GLP-1 RA trials

Original publication

Glucagon‐like peptide 1 ( GLP ‐1) receptor agonists' use during pregnancy: Safety data from regulatory clinical trials. Diabetes Obes Metab. Published 6 May 2025. doi:10.1111/dom.16437

Composed by AI from the published abstract and checked against it. How Briefs are made →

Get them every week

New studies on this topic in My Week and in your Monday e-mail.

We e-mail you a sign-in link and a code. No password, no spam.