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SPINOZA

RecruitingPhase 2

Randomized Study to Evaluate the Effect of Obicetrapib in Participants With Preclinical Alzheimer's Disease

A Phase 2b, Randomized, Double Blind, Placebo Controlled, Parallel Group Trial to Assess the Efficacy and Safety of Obicetrapib in Participants With Preclinical Alzheimer's Disease (SPINOZA Trial)

Asset

Obicetrapib

Listed sites

1

Recruiting sites

1

Enrollment

400

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Preclinical/asymptomatic AD

Primary endpoint

•Phosphorylated tau 217 (p-tau217)

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

NCT IDNCT07794670
Org study IDTA 8995 AD 2

Timeline

Milestones

Study first posted2026-08-31actual
Study start2026-09estimated (month precision)
Last update posted2026-09-28actual
Primary completion2028-09estimated (month precision)
Study completion2029-05estimated (month precision)

Assets

Drug assets

Obicetrapib

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•participants with preclinical AD

Exclusion criteria

•APOE genotype not meeting protocol-defined eligibility criteria

Endpoints (6)

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

Amyloid biomarkers
3
Global cognition
1
Tau biomarkers
1
Other (unclassified)
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Change From Baseline in Preclinical Alzheimer Cognitive Composite 5 (PACC5) Score

Time frame:Baseline, Week 52

change from baseline, improvement

Amyloid biomarkers

3 endpoints
Secondary/protocol endpoint

Change from Baseline to Week 52 in Alzheimer's disease related biomarker Amyloid β 42/Amyloid β 40 ratio

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline to Week 52 in Alzheimer's disease related biomarker p-tau217/Amyloid β42 ratio

Time frame:Baseline, Week 52

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline to Week 52 in Alzheimer's disease related biomarker p-tau217/Amyloid β42/Amyloid β40 ratio

Time frame:Baseline, Week 52

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Tau biomarkers

1 endpoint
Primary/protocol endpoint

Change from Baseline to Week 52 in ptau 217

Time frame:Baseline, Week 52

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change from Baseline to Week 52 in Alzheimer's disease related biomarker BD-tau

Time frame:Baseline, Week 52

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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 November 5, 2026 snapshot.