CompletedPhase 2Results posted

Proof-of-concept, Open-label Study in Patients With Early Alzheimer's Disease

A Phase 2a, Proof-of-Concept, Open-Label Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Obicetrapib in Patients With Early Alzheimer's Disease (Hetero/Homozygote APOE4 Carriers)

Lead sponsor

NewAmsterdam Pharma

Asset

Obicetrapib

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 20

Primary endpoints

•Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Cerebrospinal Fluid (CSF)•Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Plasma•Mean Percent Change in Apolipoprotein-E (ApoE) in Cerebrospinal Fluid (CSF)

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 IDNCT05161715

Org study IDTA-8995 AD-1

Timeline

Milestones

Study first posted2021-12-17actual

Study start2022-01-12actual

Primary completion2023-05-09actual

Study completion2023-06-01actual

Results first posted2024-11-19actual

Last update posted2025-01-29actual

Assets

Drug assets

Obicetrapib

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•men \& women 50-75 years

•post-menopausal or women not of child-bearing potential

•diagnosis of Alzheimer's disease based on National Institute for Aging:

•Biomarker classification A+T+N+ or A+T+N-

•Clinical Stage 3 or 4 with Clinical Dementia Rating score >/= 0.5 \& </= 1; mini-mental state examination (MMSE) score >/=20

•Have an APOE genotype of E4/E4 or E3/E4

•not on or on stabilized AD medication

•Patient \& study partner willing to sign consent

Exclusion criteria

•Other than AD, disorder that may impair cognition

•Contra-indication for MRI

•History of neurological, psychiatric or mental conditions;

-history stroke

-MI

-Type 1 diabetes \& Type 2 with HbA1c>8%

-BP > 150/90 mmHg

-renal or hepatic impaired

-hyperaldosteronism

-cancer

-depression

-laboratory abnormalities

-not able to undergo lumbar puncture

-taking certain medications including lipid altering

Endpoints (18)

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

Fluid / digital biomarkers

Other clinical outcomes

Other (unclassified)

Fluid / digital biomarkers

10 endpoints

Primary/protocol endpoint

Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Cerebrospinal Fluid (CSF)

Time frame:24 weeks

percent change from baseline, improvement

Primary/protocol endpoint

Mean Percent Change in Apolipoprotein-E (ApoE) in Cerebrospinal Fluid (CSF)

Time frame:24 weeks

percent change from baseline, improvement

Primary/protocol endpoint

Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Baseline

Time frame:baseline

concentration, descriptive

Primary/protocol endpoint

Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Week 24

Time frame:Week 24

concentration, descriptive

Primary/protocol endpoint

Mean Percent Change in Cholesterol Efflux Capacity in Cerebrospinal Fluid (CSF)

Time frame:24 weeks

percent change from baseline, improvement

Primary/registry result

Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Cerebrospinal Fluid (CSF)

Time frame:24 weeks

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change from screening visit	Standard deviation
10mg Obicetrapibn=12 Participants	-8.4	13.6

p0.425Wilcoxon (Mann-Whitney)

Primary/registry result

Mean Percent Change in Apolipoprotein-E (ApoE) in Cerebrospinal Fluid (CSF)

Time frame:24 weeks

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change from screening	Standard deviation
10mg Obicetrapib Tabletsn=12 Participants	3.9	10.3

p0.0424Wilcoxon (Mann-Whitney)

Primary/registry result

Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Baseline

Time frame:baseline

concentration, descriptive

Posted result

Group	Value (mean), average relative abundance	Standard deviation
10mg Obicetrapib Tabletsn=12 Participants	0.542	0.138

Primary/registry result

Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Week 24

Time frame:Week 24

concentration, descriptive

Posted result

Group	Value (mean), average relative abundance	Standard deviation
10mg Obicetrapib Tabletsn=12 Participants	0.542	0.106

Primary/registry result

Mean Percent Change in Cholesterol Efflux Capacity in Cerebrospinal Fluid (CSF)

Time frame:24 weeks

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change from screening	Standard deviation
10mg Obicetrapib Tabletsn=12 Participants	1.9	24.1

p0.556Wilcoxon (Mann-Whitney)

Other clinical outcomes

4 endpoints

Primary/protocol endpoint

Small HDL (s-HDL) Particle Concentration in Plasma at Baseline

Time frame:baseline

concentration, descriptive

Primary/protocol endpoint

Small HDL (s-HDL) Particle Concentration in Plasma at Week 24

Time frame:Week 24

concentration, descriptive

Primary/registry result

Small HDL (s-HDL) Particle Concentration in Plasma at Baseline

Time frame:baseline

concentration, descriptive

Primary/registry result

Small HDL (s-HDL) Particle Concentration in Plasma at Week 24

Time frame:Week 24

concentration, descriptive

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Plasma

Time frame:24 weeks

percent change from baseline, improvement

Primary/protocol endpoint/low confidence

Mean Percent Change in Apolipoprotein-E (ApoE) in Plasma

Time frame:24 weeks

percent change from baseline, improvement

Primary/registry result/low confidence

Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Plasma

Time frame:24 weeks

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change from baseline	Standard deviation
10mg Obicetrapib Tabletsn=13 Participants	37.5	25.2

p0.0002Wilcoxon (Mann-Whitney)

Primary/registry result/low confidence

Mean Percent Change in Apolipoprotein-E (ApoE) in Plasma

Time frame:24 weeks

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change from baseline	Standard deviation
10mg Obicetrapib Tabletsn=13 Participants	47.8	46.9

p0.001Wilcoxon (Mann-Whitney)

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.