Alzheimers Disease / Semaglutide · Phase 3 Trial

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

ClinicalTrials.gov · August 18, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 3 trial registration (not a results report) examining semaglutide's effects on immune biomarkers and gene expression in 23 people with Alzheimer's disease over 77 weeks. The trial has completed recruitment but no efficacy or safety results are posted in this registry record, making it impossible to assess clinical benefit.

What was studied

Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Alzheimers Disease; age from 55 Years; to 75 Years. Intervention: Study intervention period 1. Compared with: Study intervention period 2 — Placebo Comparator. n = 23. 12 sites across 6 countries.

Key findings

Safety

Open-label phase after week 12 precludes valid comparison of long-term safety and efficacy.

Who this may help

No clinical impact can be assessed from this registry record, as no results are reported. Clinicians should await publication of primary outcome data and any clinical efficacy measures before considering implications for Alzheimer's disease treatment.

Plain-language summary

Phase 3 trial with completed recruitment (n=23) examining surrogate immune endpoints in Alzheimer's disease; no results posted in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Change in Gene Expression Assessed by Single-cell Ribonucleic Acid Sequencing (scRNAseq) (Cells in Cerebrospinal Fluid [CSF]) (assessed at Baseline (week 0), week 12); Change in Gene Expression Assessed by scRNAseq (Cells in Blood) (assessed at Baseline (week 0), week 12)

DesignPhase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationAlzheimers Disease; age from 55 Years; to 75 Years

Sample size23

InterventionStudy intervention period 1

ComparatorStudy intervention period 2 — Placebo Comparator

Setting12 sites across 6 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment23

PhasePhase 3

Primary outcome measure 1Change in Gene Expression Assessed by scRNAseq (Cells in Cerebrospinal Fluid [CSF]), Baseline (week 0), week 12

Primary outcome measure 2Change in Gene Expression Assessed by scRNAseq (Cells in Blood), Baseline (week 0), week 12

Study duration77 weeks

Blinded treatment period12 weeks (randomized placebo-controlled)

Open-label treatment period52 weeks (all participants receive semaglutide)

Clinical bottom line

Caveats

No results posted in registry record; this is a study registration only.
Primary outcomes are surrogate biomarkers (gene expression); clinical endpoints such as cognition or functional decline are not stated.
Sample size (n=23) is very small for Phase 3 and inadequate for definitive conclusions.
Open-label phase after week 12 precludes valid comparison of long-term safety and efficacy.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 3, randomized, placebo-controlled, but very small sample size limits power.

Directness

limited

Primary outcomes are gene expression changes in CSF and blood cells; clinical relevance to Alzheimer's disease unclear.

Consistency

insufficient

No results reported in registry record; consistency cannot be assessed.

Risk of bias

moderate

Randomized placebo-controlled design mitigates bias, but open-label phase 2 (weeks 12–77) introduces unblinded treatment exposure.

Sample adequacy

limited

Enrollment of 23 participants is very small for Phase 3; severely underpowered for clinical conclusions.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05891496). This is a study registration, not published results. Lead sponsor: Novo Nordisk A/S. Recruitment status: COMPLETED. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 23 participants (ACTUAL). Conditions: Alzheimers Disease. Interventions: DRUG: Semaglutide; DRUG: Placebo. Primary outcome measures: Change in Gene Expression Assessed by Single-cell Ribonucleic Acid Sequencing (scRNAseq) (Cells in Cerebrospinal Fluid [CSF]) , Baseline (week 0), week 12; Change in Gene Expression Assessed by scRNAseq (Cells in Blood) , Baseline (week 0), week 12. Brief summary: The study is being conducted to understand how the medicine, semaglutide, affects the immune system and other biological processes in people with Alzheimer's disease. Semaglutide is a medicine that doctors can prescribe in some countries for the treatment of type 2 diabetes and excess body weight. This study will help us understand whether semaglutide can also be used for the treatment of Alzheimer's disease. The study will last for about 77 weeks. In the first 12 weeks of treatment, participants will either get semaglutide (active medicine) or placebo (inactive dummy medicine). Which treatment participants get is decided by chance. In the following 52 weeks of treatment, all participants taking part in the study will get semaglutide. Participants must have a study partner, who is willing to take part in the study. Participants will get study medicine in a pen injector. The study partner will need to inject the study medicine into the skin of participant's stomach, thigh or upper arm once every week.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Novo NordiskAlzheimers DiseaseSemaglutideNCT05891496