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RecruitingNCT07794670SPINOZAUpdated Sep 28, 2026

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

A Phase 2 interventional study of Obicetrapib 10 mg and Matching placebo tablets in Preclinical Alzheimer's Disease, sponsored by NewAmsterdam Pharma. Recruiting at 1 site in United States. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by NewAmsterdam Pharma · Phase 2, Interventional, and Prevention

Updated Sep 28, 2026Now RecruitingFirst site in United States+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
55 Years to 85 Years
Sex
All
01

Study summary

A study evaluating Obicetrapib in adults potentially at risk for Preclinical Alzheimer's Disease

02

Conditions studied

  • Preclinical Alzheimer's Disease

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Keywords

  • Preclinical
  • Alzheimer's Disease
  • ptau 217
  • ApoE
03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's planned enrollment of 400 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

NewAmsterdam Pharma is the lead sponsor of 20 studies on the registry; 3 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 8 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • participants with preclinical AD

Exclusion criteria

Exclusion Criteria:

  • APOE genotype not meeting protocol-defined eligibility criteria
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
400 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Placebo

    Drug: Matching placebo tablets

  • Experimental
    Obicetrapib

    10 mg Obicetrapib, once daily

    Drug: Obicetrapib 10 mg

Interventions

  • DrugObicetrapib 10 mg

    once daily 10 mg Obicetrapib tablet

  • DrugMatching placebo tablets

    matching placebo tablet

06

What researchers measure

Primary outcomes

  1. Change from Baseline to Week 52 in ptau 217

    Time frame: Baseline, Week 52

Secondary outcomes

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

    Measure changes in proteins that can be early signs of Alzheimer's disease.

    Time frame: Baseline, Week 52

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

    Measure changes in two proteins that can be early signs of Alzheimer's disease.

    Time frame: Baseline, Week 52

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

    Measure changes in three proteins that can be early signs of Alzheimer's disease.

    Time frame: Baseline, Week 52

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

    Measures a protein released from brain cells that can be early signs of Alzheimer's disease.

    Time frame: Baseline, Week 52

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

    The PACC5 is a standardized set of tests used to measure memory and thinking skills. It is designed to find small changes in memory and thinking that may happen before symptoms of Alzheimer's disease appear. The composite score is derived from standardized scores on five assessments that measure different skills: memory, delayed memory, overall thinking, speed of thinking, and language skills. Higher scores mean better memory and thinking performance.

    Time frame: Baseline, Week 52

07

Study locations

1 of 1 sites recruiting
08

References and documents

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.

Of 130 industry-sponsored phase 2 interventional studies under Alzheimer Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 39. This study's planned 24 months is close to that.

Counting every sponsor, half of 257 studies reached it within 37 months; a quarter within 21 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2026
First posted
Aug 31, 2026
StartEst.
Sep 2026
Primary completionEst.
Sep 2028
CompletionEst.
May 2029
Last update
Sep 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Sep 28, 2026
Sites
1 site added — first site in United States
Show site
  • K2 Medical Research · Nashville, United States
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in United States
    Show site
    • K2 Medical Research · Nashville, United States
    + 2 other changes: verification date and references

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07794670
Lead sponsor
NewAmsterdam Pharma
Responsible party
Sponsor
First posted
Aug 31, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2028 (estimated)
Completion
May 2029 (estimated)
Last update
Sep 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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