Alzheimer's & dementia (New York, N. Y.)

Participant characteristics in two phase 3 trials of semaglutide for early symptomatic Alzheimer's disease

Updated

Abstract

Essence

The evoke and evoke+ semaglutide Alzheimer's trials enrolled a large global early-stage symptomatic population before efficacy results were available.

Evidence

This baseline descriptive report covers 9996 amyloid-positive participants from 566 sites in 40 countries in two ongoing randomized, double-blind, placebo-controlled phase 3 trials of oral semaglutide 14 mg versus placebo for 156 weeks.

Caveat

The abstract reports baseline characteristics only, with primary efficacy and safety readouts expected in the second half of 2025.

Simplified

Key numbers

9996
Participants Screened
Total number of participants screened in the trials.
71.8 years
Mean Age
Mean age of participants in the evoke trial.
53.0%
Female Participants
Proportion of female participants in the evoke trial.

Full Text

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Funding

Competing interests

Philip Scheltens is a full‐time employee of EQT Life Sciences (formerly LSP) and Professor Emeritus at Amsterdam UMC. He is co‐Chair of the Steering Committee for the phase 3 studies evoke and evoke+ with Novo Nordisk. Alireza Atri has received honoraria or support for consulting; participating in independent data safety monitoring boards; providing educational lectures, programs, and materials; and serving on advisory boards for AbbVie, Acadia, Allergan, the Alzheimer's Association, Axovant, AZTherapies, Biogen, Eisai, Grifols, Harvard Medical School Graduate Continuing Education, JOMDD, Lundbeck, Merck, Novo Nordisk, Prothena, Qynapse, Roche/Genentech, Sunovion, Suven, and Synexus. He receives book royalties from Oxford University Press for a medical book on dementia. He receives institutional research grant/contract funding from National Institute on Aging/National Institutes of Health (NIA/NIH; 1P30AG072980), NIA/NIH U24AG057437, AZ DHS (CTR040636), Foundation for NIH (FNIH), Washington University in St. Louis, and Gates Ventures. His institution has received/receives funding for clinical trial grants, contracts, and projects from government, consortia, foundations, and companies, for which he has served/serves as a contracted site principal investigator. He has received/receives honoraria from Novo Nordisk for consulting activities, including for service on the evoke (+) program Steering Committee. Howard H. Feldman reports grants to the University of California San Diego (UCSD) from LuMind Foundation, Annovis (QR Pharma), AC Immune, Biohaven, and Vivoryon (Probiodrug). He also reports service agreements through UCSD for consulting with Arrowhead Pharmaceuticals, Axon Neuroscience, LuMind Foundation, and Novo Nordisk. He reports serving on a data monitoring committee and data and safety monitoring board for Janssen Research & Development and Roche/Genentech with service agreements through UCSD, and serving on the Scientific Advisory Board for the Tau Consortium. He reports travel expenses through UCSD from Novo Nordisk and Royal Society of Canada. He receives personal funds for Detecting and Treating Dementia (Serial Number 12/3‐ 2691 U.S. Patent No. PCT/US2007/07008, Washington DC, U.S. Patent and Trademark Office). He has also received philanthropic support for Alzheimer's therapeutic research through the Epstein Family Alzheimer's Research Collaboration. Henrik Zetterberg reports a relationship with AbbVie, Acumen, Alector, Alzinova, ALZpath, Amylyx, Annexon, Apellis, Artery Therapeutics, AZTherapies, Cognito Therapeutics, CogRx, Denali, Eisai, Enigma, LabCorp, Merck Sharp & Dohme, Merry Life, Nervgen, Novo Nordisk, Optoceutics, Passage Bio, Pinteon Therapeutics, Prothena, Quanterix, Red Abbey Labs, reMYND, Roche, Samumed, ScandiBio Therapeutics AB, Siemens Healthineers, Triplet Therapeutics, and Wave that includes: consulting or advisory. He reports a relationship with Alzecure, BioArctic, Biogen, Cellectricon, Fujirebio, LabCorp, Lilly, Novo Nordisk, Oy Medix Biochemica AB, Roche, and WebMD that includes: speaking and lecture fees. He reports a relationship with Brain Biomarker Solutions in Gothenburg AB that includes equity or stocks. Mary Sano has served on the Scientific Advisory Board for Medication and as a consultant for Eisai, Avenir, vTv, Biogen, BioXcel, F. Hoffman LaRoche, Merck, Novo Nordisk, Novartis, Otsuka, Genentech, and BioVie. She is a member of the Alzheimer Association Medical and Scientific Advisory Group and Chair of DSMB: Phase II Trial to Evaluate Safety and Efficacy of GM‐CSF/Sargramostim in Alzheimer's Disease (SESAD) (sponsor: University of Colorado). Peter Johannsen, Teresa León Colombo, Rose Jeppesen, Charlotte T. Hansen, and Lars Bardtrum are employees of and/or minor shareholders of Novo Nordisk A/S. Jeffrey L. Cummings has provided consultation to Acadia, Actinogen, Acumen, AlphaCognition, ALZpath, Aprinoia, AriBio, Artery, Biogen, Biohaven, BioVie, BioXcel, Bristol Myers Squibb, Cassava, Cerecin, Diadem, Eisai, GAP Foundation, GemVax, Janssen, Jocasta, Karuna, Lighthouse, Lilly, Lundbeck, LSP/eqt, Merck, NervGen, New Amsterdam, Novo Nordisk, Oligomerix, Optoceutics, Ono, Otsuka, Oxford Brain Diagnostics, Prothena, ReMYND, Roche, Sage Therapeutics, Signant Health, Simcere, sinaptica, Suven, TrueBinding, Vaxxinity, and Wren pharmaceutical, assessment, and investment companies. He is supported by NIGMS grant P20GM109025, NIA grant R35AG71476, NIA R25 AG083721‐01, Alzheimer's Disease Drug Discovery Foundation, Ted and Maria Quirk Endowment, and Joy Chambers‐Grundy Endowment.
PubMed

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