Saturday, August 09, 2025 5:26:08 PM
Last year, the results of a huge study of about 8,600 people aged 55 years or older taking Novo's new-generation GLP-1 drug, Semaglutide, was released. (Interestingly, the lead doctor was Marwan Sabbagh)
Safety Profile of Semaglutide in People Aged 55 Years and Over: Pooled Data from the PIONEER, SUSTAIN, and STEP Phase 3 Clinical Programmes (P11-9.014)
https://www.neurology.org/doi/abs/10.1212/WNL.0000000000204711
Background:
The glucagon-like peptide-1 analogue semaglutide, approved for type 2 diabetes (T2D) and overweight/obesity, is being investigated in the phase 3 evoke and evoke+ trials in people with early AD aged 55–85 years.
Results:
Data from 8595 participants were included. At baseline in the PIONEER, SUSTAIN and STEP pooled datasets, mean (standard deviation [SD]) age was 64.3 (6.4), 63.5 (6.1) and 62.0 (5.6) years, respectively, and mean (SD) body mass index was 30.8 (6.2), 31.0 (6.2) and 35.6 (6.2) kg/m2. The percentages of participants with adverse events (AEs) leading to treatment discontinuation in the semaglutide arms of PIONEER, SUSTAIN and STEP were 10.2, 9.1 and 7.7%, respectively, versus 5.2, 3.9 and 3.3% for the comparator arms. Gastrointestinal disorders were the most frequently reported AE system organ class in the semaglutide arm of each pooled dataset. Weight loss was greater with semaglutide versus comparator in all trials, with a tendency to plateau over time.
Conclusions:
The safety profile of semaglutide in participants 55+ years is similar to that observed in the overall population, supporting the evaluation of semaglutide in an older population with early AD in the evoke trials.
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