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

May 7, 2025Diabetes, obesity & metabolism

Safety of Using GLP-1 Receptor Drugs During Pregnancy Based on Clinical Trial Data

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Abstract

The incidence of congenital abnormalities in humans appears relatively low following Glucagon-like peptide-1 receptor agonist use during pregnancy.

Evidence regarding planned pregnancies with Glucagon-like peptide-1 receptor agonists is currently lacking.
Data on unplanned pregnancies during clinical trials indicates potential safety concerns for the use of these drugs in pregnant women.
Key knowledge gaps exist that must be addressed before these medications can be safely introduced for pregnant women.
It is recommended to discontinue Glucagon-like peptide-1 receptor agonists upon awareness of a pregnancy.
Establishing patient registries to capture data on drug exposure during pregnancy is considered a high priority.

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AIMS: The prevalence of diabetes and obesity continues to rise in women of reproductive age, with significant implications for both mother and foetus. Glucagon-like peptide-1 receptor agonists are effective treatments of diabetes and obesity. However, no Glucagon-like peptide-1 receptor agonists are currently approved for use during pregnancy. We describe the outcomes of unplanned pregnancies during regulatory clinical trials of Glucagon-like peptide-1 receptor agonists submitted to the Food and Drug Administration and European Medicines Agency.

MATERIALS AND METHODS: A search was conducted of the regulatory documentation published by the European Medicines Agency and the Food and Drug Administration on unplanned pregnancies during regulatory clinical trials of Glucagon-like peptide-1 receptor agonists. Clinical and Medical Reviews published by the Center for Drug Evaluation and Research at the Food and Drug Administration for every Glucagon-like peptide-1 receptor agonist prior to market authorisation were assessed to gather information on unplanned pregnancies that occurred while females were partaking in the clinical development programmes of such drugs.

RESULTS: Evidence in women having planned pregnancies is lacking, and the only evidence thus far relies on pregnancies occurring inadvertently during Glucagon-like peptide-1 receptor agonist trials. The incidence of congenital abnormalities in humans appears relatively low following Glucagon-like peptide-1 receptor agonist use during pregnancy.

CONCLUSIONS: 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.

Key numbers

2.7%

Congenital Abnormalities Rate

Congenital abnormalities in GLP1-RA exposure group.

22%

Spontaneous Abortion Rate

Spontaneous abortions in GLP1-RA exposure group.

43%

Healthy Births Rate

Healthy children born to mothers exposed to GLP1-RAs.

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

Abstract

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