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Abstract Details

Safety Profile of Semaglutide in People Aged 55 Years and Over: Pooled Data from the PIONEER, SUSTAIN, and STEP Phase 3 Clinical Programmes
Aging, Dementia, Cognitive, and Behavioral Neurology
P11 - Poster Session 11 (5:30 PM-6:30 PM)
9-014
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.
We investigated the safety of semaglutide in people with T2D and/or overweight/obesity ≥55 years from the phase 3a PIONEER, SUSTAIN and STEP clinical programmes.

Safety data for participants ≥55 years were pooled for: people with T2D receiving once-daily oral semaglutide 3, 7 or 14 mg versus comparator (active or placebo) for 26?78 weeks in PIONEER 1?5 and 7?10 (PIONEER pool, N=4186); people with T2D receiving once-weekly subcutaneous semaglutide 0.5 or 1 mg versus comparator (active or placebo) for 30?56 weeks in SUSTAIN 1?5 and SUSTAIN Japan (NCT02207374 and NCT02254291; SUSTAIN pool, N=2825); and people with overweight/obesity (with/without T2D) receiving once-weekly subcutaneous semaglutide 2.4 mg versus placebo for 68?104 weeks in STEP 1–6 (STEP pool, N=1584).

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.

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.
Authors/Disclosures
Marwan N. Sabbagh, MD, FAAN (Barrow Neurological Institute)
PRESENTER
Dr. Sabbagh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eisai. Dr. Sabbagh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genetech=Roche. Dr. Sabbagh has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novo Nordisk. Dr. Sabbagh has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly. Dr. Sabbagh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Synaptogenix. Dr. Sabbagh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Signant Health. Dr. Sabbagh has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Anavex. Dr. Sabbagh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Prothena. Dr. Sabbagh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cognito Therapeutics. Dr. Sabbagh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GSK. Dr. Sabbagh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Sabbagh has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for CervoMed. Dr. Sabbagh has stock in Neurotau. Dr. Sabbagh has stock in Seq Biomarque. Dr. Sabbagh has stock in uMethod Health. Dr. Sabbagh has stock in Athira. Dr. Sabbagh has stock in Lighthouse Pharmaceuticals. Dr. Sabbagh has stock in Alzheon. The institution of Dr. Sabbagh has received research support from NIH. The institution of Dr. Sabbagh has received research support from ADDF.
Cristina Boschini No disclosure on file
Sharon Cohen, MD The institution of Dr. Cohen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alnylam. The institution of Dr. Cohen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. The institution of Dr. Cohen has received personal compensation in the range of $0-$499 for serving as a Consultant for Diamond Therapeutics Inc.. The institution of Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. The institution of Dr. Cohen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for ProMIS Neurosciences Inc.. The institution of Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for RetiSpec Inc.. The institution of Dr. Cohen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for College of Physicians and Surgeons of Ontario. The institution of Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CME Outfitters. The institution of Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Integritas. The institution of Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for DBK Med.
Magnus Fugger (Novo Nordisk) No disclosure on file
Frank Jessen No disclosure on file
Gabriel Martino (Novo Nordisk) No disclosure on file
Sue Pedersen (C-ENDO Clinic Calgary) No disclosure on file
Luis Rafael Solís-Tarazona, MD Mr. Solís-Tarazona has received personal compensation for serving as an employee of Novo Nordisk A/S.
Vanita Aroda (Brigham and Women's Hospital) No disclosure on file