CompletedPhase 3Results posted

A Research Study Looking at the Effect of Semaglutide on the Immune System and Other Biological Processes in People With Alzheimer's Disease

A Randomised Double-blind Placebo-controlled Clinical Study Investigating the Effects of Semaglutide s.c. Once-weekly Versus Placebo on Central and Peripheral Inflammation in Participants With Alzheimer's Disease

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•CDR global 0.5•AD symptomatic therapy: stable

Primary endpoint

•Gene Expression

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2022-003384-24

Secondary ID2023-506825-13EU CT Number

NCT IDNCT05891496

Org study IDNN6535-7519

Secondary IDU1111-1283-8743World Health Organisation (WHO)

Timeline

Milestones

Study first posted2023-06-07actual

Study start2023-06-20actual

Primary completion2024-08-19actual

Study completion2025-09-08actual

Last update posted2026-02-24actual

Results first posted2026-02-24actual

Assets

Drug assets

Semaglutide

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female, aged 55-75 years (both inclusive) at the time of signing the informed consent

•Mild cognitive impairment (MCI) or mild dementia of the Alzheimer's type according to the National Institute on Aging- Alzheimer's Association (NIA-AA) 2018 criteria

•Clinical dementia rating (CDR) global score of 0.5 or 1 at screening (visit 1)

•Amyloid positivity established with either historical amyloid positron emission tomography (PET) or historical cerebrospinal fluid (CSF) Aβ1-42 or historical CSF Aβ1-42/Aβ1-40 (historical data within the last 5 years) or blood sample for amyloid biomarker (Aβ42/Aβ40 ratio and p-tau217/np-tau217 ratio) at screening (visit 1)

•Treated with acetylcholinesterase inhibitors (approved for the treatment of Alzheimer's disease) and on stable dose for greater than 90 days before screening (visit 1)

Exclusion criteria

•Brain magnetic resonance imaging (MRI) scan suggestive of clinically significant structural central nervous system (CNS) disease confirmed by local read (example cerebral large-vessel disease [large vessel (cortical) infarcts greater than 10 millimeter (mm) in diameter], prior macro-haemorrhage [greater than 1centimeter cube (cm^3)], cerebral vascular malformations, cortical hemosiderosis, intracranial aneurism(s), intracranial tumours, changes suggestive of normal pressure hydrocephalus)

•Brain MRI scan suggestive of significant small vessel pathology confirmed by local read and defined as greater than 1 lacunar infarct and/or white matter hyperintensity (WMH) Fazekas13 scale greater than 2, (white matter [WM] greater than 20 mm) in the deep white matter and periventricular regions

•History or evidence of autoimmune diseases such as inflammatory bowel disease, rheumatoid arthritis, lupus, glomerulonephritis, psoriasis (but not limited to): Any other medical condition that would require use of systemic corticosteroids or immunosuppressants or immunostimulants in the 12 months prior to screening (visit 1)

•Received a vaccine product (including booster) 4 weeks prior to screening (visit 1) or expected to receive a vaccine product (including booster) before visit 5

•Use of any systemic immunomodulating drugs (small molecules and/or biologics) in the last 12 months prior to screening (visit 1) or anticipated use of such drugs during study intervention period 1 (i.e., during the first 12 weeks of treatment until visit 5), such as corticosteroids for systemic use, immunostimulants and immunosuppressants

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Fluid / digital biomarkers

2 endpoints

Primary/protocol endpoint

Change in Gene Expression Assessed by Single-cell Ribonucleic Acid Sequencing (scRNAseq) (Cells in Cerebrospinal Fluid [CSF])

Time frame:Baseline (week 0), week 12

change from baseline, improvement

Primary/registry result

Change in Gene Expression Assessed by Single-cell Ribonucleic Acid Sequencing (scRNAseq) (Cells in Cerebrospinal Fluid [CSF])

Time frame:Baseline (week 0), week 12

change from baseline, improvement

Posted result

Group	Value (mean), Differentially expressed genes	Standard deviation
Semaglutiden=4 Participants	41.25	29.68
Placebon=7 Participants	21.00	25.70

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:From baseline (week 0) to week 12

event count, event

Secondary/protocol endpoint

Weekly Average Semaglutide Concentration [Average Concentration (Cavg)] Based on Population Pharmacokinetics (PK) Analysis

Time frame:From week 4 to week 64

concentration, descriptive

Secondary/registry result

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:From baseline (week 0) to week 12

event count, event

Posted result

Group	Value (number), Events	Reported bounds
Semaglutiden=11 Participants	31	-
Placebon=12 Participants	8	-

Secondary/registry result

Weekly Average Semaglutide Concentration [Average Concentration (Cavg)] Based on Population Pharmacokinetics (PK) Analysis

Time frame:From week 4 to week 64

concentration, descriptive

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

Change in Gene Expression Assessed by scRNAseq (Cells in Blood)

Time frame:Baseline (week 0), week 12

change from baseline, improvement

Primary/registry result/low confidence

Change in Gene Expression Assessed by scRNAseq (Cells in Blood)

Time frame:Baseline (week 0), week 12

change from baseline, improvement

Posted result

Group	Value (mean), Differentially expressed genes	Standard deviation
Semaglutiden=7 Participants	10.00	5.97
Placebon=6 Participants	16.50	15.86

Secondary/protocol endpoint/low confidence

Number of TEAEs

Time frame:From baseline (week 0) to week 64

event count, event

Secondary/registry result/low confidence

Number of TEAEs

Time frame:From baseline (week 0) to week 64

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.