Recent Updates
Recently added Catalysts

Semagludtide

Phase 3

Early Alzheimer's Disease | Small molecule | Neurology |Novo Nordisk A/S|Last Updated: Jul 7, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment1,840

FDA Designations

No designations recorded

Clinical trial landscape

Semagludtide · 1 trial · 1 indication

Phase 3 1
NCT04777396A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE)Early Alzheimer's Disease
COMPLETED1,840 Analytics
PHASE3COMPLETED
A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE)
Early Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score
From baseline (week 0) to week 104

Score on scale (0 to 18) Measures the impact of cognitive decline on daily function using the following six domains commonly affected in Alzheimer's disease: * Cognitive domains: memory, orientation, and judgement and problem solving * Function domains: community affairs, home and hobbies, and personal care Based on clinical information obtained from the subject and informant, an individual box score ranging from 0 to 3 is determined that represents "none" to "severe" impairment for each of the six domains. The CDR-Sum of Boxes (CDR-SB) score will be derived by adding the individual scores of the six domains at a given time point. The total CDR-SB score ranges from 0 to 18 with higher scores representing greater impairment.

Secondary Endpoints

Main Phase: Change in the 24-item Alzheimer's Disease Cooperative Study Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-ADL-MCI) score
From baseline (week 0) to week 104
Extension Phase:Change in the ADCS-ADL-MCI (Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory-Mild Cognitive Impairment ) score
From baseline (week 0) to week 156
Main Phase: Time to progression to Clinical Dementia Rating (CDR) global score greater than or equal to (≥) 1.0 among patients with CDR global score equal to (=) 0.5 at baseline
From baseline (week 0) up to week 156
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Oral SemaglutideEXPERIMENTALParticipants are given oral semaglutide once daily
Placebo (semagludtide)PLACEBO_COMPARATORParticipants are given oral placebo once daily

Interventions

NameTypeDescription
SemagludtideDRUGOral semaglutide once-daily, dose gradually increased to 14 mg. The study will last for up to 173 weeks
Placebo (semaglutide)DRUGOral placebo (semaglutide) once-daily, The study will last for up to 173 weeks
Unlock Study Design Details

Eligibility Criteria

Age Range55 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites447

Inclusion Criteria: * Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent. * MCI (mild cognitive impairment) or mild dementia of the Alzheimer's type according to the NIA-AA (National Institute of Aging-Alzheimer's Association) 2018 criteria. * CDR (Clinical De...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilBulgariaCanadaCzechiaDenmarkFinlandFranceGermanyGreeceHungaryIrelandIsraelItalyJapanMexicoNetherlandsNorwayPolandPortugalRomaniaRussiaSerbiaSlovakiaSloveniaSouth AfricaSouth KoreaSpainSwedenSwitzerlandTurkey (Türkiye)UkraineUnited Kingdom
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

MEDIUMAug 7, 2026NCT04777396TRIAL_REMOVED: changed
MEDIUMAug 7, 2026NCT04777396TRIAL_REMOVED: changed
MEDIUMAug 7, 2026NCT04777396TRIAL_REMOVED: changed

Frequently asked questions about Semagludtide

What is Semaglutide used for in early Alzheimer's disease?

Semaglutide is being investigated as a treatment for early Alzheimer's disease. It is a small molecule developed by Novo Nordisk A/S. The drug has completed a Phase 3 clinical trial in this indication, though it remains investigational and is not yet approved for Alzheimer's disease.

What does Semaglutide target?

Semaglutide is a small molecule being studied for early Alzheimer's disease. Its molecular target has not been specified in the available information, so its mechanism of action in this context is not detailed here.

Who makes Semaglutide?

Semaglutide is developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical research on this drug for early Alzheimer's disease.

What phase is Semaglutide in for Alzheimer's disease?

Semaglutide is in Phase 3 clinical development for early Alzheimer's disease. A Phase 3 trial has been completed, but the drug is still investigational and has not been approved by regulatory authorities for this condition.

What clinical trials is Semaglutide in for Alzheimer's disease?

Semaglutide has one completed Phase 3 trial, NCT04777396, titled 'A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE)'. This randomized, double-blind, placebo-controlled study enrolled 1,840 participants across multiple countries.

Is Semaglutide the same as semaglutide for diabetes or obesity?

Semaglutide is the same drug name used in studies for early Alzheimer's disease. The available information does not specify whether this is the identical compound used for other indications, so no distinction is made here.