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.
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.