Clinical Trials May Not Differentiate, but Data Show Women More Likely to Report Issues With GLP-1s

18 August, 2025 

Recent analyses suggest important sex- and gender-related differences in the pharmacokinetics, safety, and adverse events of GLP-1 receptor agonists:

1️⃣ Pharmacokinetics: In one study, women had 32% higher concentrations of the tested medication. Patients with diabetes had lower drug concentrations compared to those with normal or prediabetic glucose levels.

2️⃣ Neurologic adverse events :
A new analysis of FAERS (2004–2025) found that among the 250,014 adverse event reports for GLP-1 agonists, 11.58% were neurologic.
Of the 28,953 neurologic events, 65% were reported by women.
46.25% of neurologic reports occurred within 30 days of treatment initiation.
The most common events: dizziness, tremor, and dysgeusia.

3️⃣ Psychiatric adverse events: In the EudraVigilance database (Jan 2021–May 2023), women accounted for 65% of 372 psychiatric events linked to semaglutide, liraglutide, and tirzepatide.

4️⃣ Reporting gaps in clinical studies:
– A recent JAMA article on GLP-1 event management discussed only gastrointestinal issues (nausea, etc.), with no mention of neurologic complications.
– A large safety study (Feb 2025) of semaglutide 2.4 mg in overweight/obese patients with cardiovascular disease stratified safety outcomes (fractures, poisoning, procedural events) by sex, but not cardiac or nervous system disorders.
– The ongoing Evoke trials of oral semaglutide in early-stage hashtag
Alzheimer disease (n=1,840) have no sex breakdown reported in ClinicalTrials.gov or peer-reviewed summaries, despite the fact that Alzheimer’s disease disproportionately affects women.

Read the full article

Written by Christine Bahls for Medscape. Thanks to the medical experts involved: Irving Zucker, SADIYA S. KHAN, Martha Gulati and Dr. Antonella Santuccione Chadha, CEO & Founder of the Women’s Brain Foundation.

We are here to transform medicine and healthcare towards precision medicine. Right now, there is a critical need for your support. Donate today and help us continue to study Sex and Gender differences impacting brain and mental diseases.

Health begins with human beings, individuals – men and women are different when it comes to brain and mental disease frequency, severity, symptomatology, risk factors and even response to treatments. Thanks to the gifts from supporters like you the scientific community is starting to take note. We have shown the world that in diseases like Alzheimer’s for instance, disease progression is faster in women than men and women show different levels of biomarkers.

Our goal is to clearly identify such differences in diseases, diagnostic, and treatments, as well as novel technologies, and leverage them for better solutions. We ask for better clinical outcomes, better care, and innovative artificial intelligence (AI)-based solutions. Sex and gender differences are the first steps towards precision medicine, which acknowledges the specific needs of each patient. Our ultimate ambition is the realisation of the Research Institute for Sex and Gender Precision Medicine.