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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506825-13-00

Acronym

NN6535-7519

Enrollment

Registered

2023-11-17

Start date

2023-07-25

Completion date

2025-06-26

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild cognitive impairment (MCI) or mild dementia, both of the Alzheimer’s type

Brief summary

Change in gene expression assessed by single-cell ribonucleic acid sequencing (scRNAseq) (cells in CSF) from baseline (week 0) to visit 5 (week 12), Change in gene expression assessed by scRNAseq (cells in blood) from baseline (week 0) to visit 5 (week 12)

Detailed description

Number of treatment emergent adverse events (TEAEs) from baseline (week 0) to visit 5 (week 12), Number of treatment emergent adverse events (TEAEs) from baseline (week 0) to end of treatment (week 64), Weekly average semaglutide concentration (C avg) based on population pharmacokinetics (PK) analysis from visit 3 (week 4) to end of treatment (week 64)

Interventions

DRUGOzempic 1 mg solution for injection in pre-filled pen

DRUGSemaglutide Placebo

DRUGOzempic 0.5 mg solution for injection in pre-filled pen

DRUGOzempic 0.25 mg solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in gene expression assessed by single-cell ribonucleic acid sequencing (scRNAseq) (cells in CSF) from baseline (week 0) to visit 5 (week 12), Change in gene expression assessed by scRNAseq (cells in blood) from baseline (week 0) to visit 5 (week 12)	—

Secondary

Measure	Time frame
Number of treatment emergent adverse events (TEAEs) from baseline (week 0) to visit 5 (week 12), Number of treatment emergent adverse events (TEAEs) from baseline (week 0) to end of treatment (week 64), Weekly average semaglutide concentration (C avg) based on population pharmacokinetics (PK) analysis from visit 3 (week 4) to end of treatment (week 64)	—

Countries

Denmark, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026