A Phase 2 interventional study of Obicetrapib in Early Alzheimer's Disease, sponsored by NewAmsterdam Pharma. Completed at 1 site in Netherlands. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by NewAmsterdam Pharma · Phase 2, Interventional, and Prevention
A Phase 2a study in men and women with early Alzheimer's disease to evaluate the pharmacodynamics, pharmacokinetics and safety of obicetrapib therapy.
This study will be a proof of concept, Phase 2a study in patients with early Alzheimer's disease (clinical diagnosis of Alzheimer's disease Stage 3 or 4 based on the National Institute on Aging Alzheimer's Association Research Framework criteria) to evaluate the Pharmacodynamic, cognitive effects, Pharmacokinetic, and safety and tolerability of obicetrapib therapy.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 13 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →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.
Exclusion Criteria:
History of neurological, psychiatric or mental conditions;
10mg obicetrapib (5mg tablets) administered orally daily for 24 weeks
Drug: Obicetrapib
10mg obicetrapib
Also known as: TA-8995
Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Cerebrospinal Fluid (CSF)
Mean percent change from screening (V1) to end of treatment (V6) in ApoA-I in CSF
Time frame: 24 weeks
Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Plasma
Mean percent change in ApoA-I in plasma from baseline (V2) to week 24 (V6)
Time frame: 24 weeks
Mean Percent Change in Apolipoprotein-E (ApoE) in Cerebrospinal Fluid (CSF)
Mean percent change from screening (V1) to end of treatment (V6) in ApoE
Time frame: 24 weeks
Mean Percent Change in Apolipoprotein-E (ApoE) in Plasma
Mean percent change from baseline (V2) to week 24 (V6) in plasma in ApoE
Time frame: 24 weeks
Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Baseline
Small high-density lipoprotein (s-HDL) particle concentration in cerebrospinal fluid (CSF) measured by Ion Mobility Assay (https://doi.org/10.1002/alz.12649)
Time frame: baseline
Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Week 24
Small high-density lipoprotein (s-HDL) particle concentration in CSF measured by Ion Mobility Assay (https://doi.org/10.1002/alz.12649)
Time frame: Week 24
Small HDL (s-HDL) Particle Concentration in Plasma at Baseline
Small high-density lipoprotein (s-HDL) particle concentration plasma measured by Ion Mobility Assay. For more information on the measurement used please refer to this article: https://doi.org/10.1002/alz.12649
Time frame: baseline
Small HDL (s-HDL) Particle Concentration in Plasma at Week 24
Small high-density lipoprotein (s-HDL) particle concentration in plasma measured by Ion Mobility Assay at Week 24 For more information on the measurement used please refer to this article: https://doi.org/10.1002/alz.12649
Time frame: Week 24
Mean Percent Change in Cholesterol Efflux Capacity in Cerebrospinal Fluid (CSF)
Mean percent change in cholesterol efflux capacity in CSF from screening (V1) to week 24 (V6)
Time frame: 24 weeks
| Milestone | 10mg Obicetrapib |
|---|---|
| Started | 13 |
| Completed | 13 |
| Not completed | 0 |
Mean percent change from screening (V1) to end of treatment (V6) in ApoA-I in CSF
| percent change from screening visit | 10mg Obicetrapib |
|---|---|
| Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Cerebrospinal Fluid (CSF) | -8.4 ± 13.6 |
Mean percent change in ApoA-I in plasma from baseline (V2) to week 24 (V6)
| percent change from baseline | 10mg Obicetrapib Tablets |
|---|---|
| Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Plasma | 37.5 ± 25.2 |
Mean percent change from screening (V1) to end of treatment (V6) in ApoE
| percent change from screening | 10mg Obicetrapib Tablets |
|---|---|
| Mean Percent Change in Apolipoprotein-E (ApoE) in Cerebrospinal Fluid (CSF) | 3.9 ± 10.3 |
Mean percent change from baseline (V2) to week 24 (V6) in plasma in ApoE
| percent change from baseline | 10mg Obicetrapib Tablets |
|---|---|
| Mean Percent Change in Apolipoprotein-E (ApoE) in Plasma | 47.8 ± 46.9 |
Small high-density lipoprotein (s-HDL) particle concentration in cerebrospinal fluid (CSF) measured by Ion Mobility Assay (https://doi.org/10.1002/alz.12649)
| average relative abundance | 10mg Obicetrapib Tablets |
|---|---|
| Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Baseline | 0.542 ± 0.138 |
Small high-density lipoprotein (s-HDL) particle concentration in CSF measured by Ion Mobility Assay (https://doi.org/10.1002/alz.12649)
| average relative abundance | 10mg Obicetrapib Tablets |
|---|---|
| Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Week 24 | 0.542 ± 0.106 |
Small high-density lipoprotein (s-HDL) particle concentration plasma measured by Ion Mobility Assay. For more information on the measurement used please refer to this article: https://doi.org/10.1002/alz.12649
No measurements were reported for this outcome.
Small high-density lipoprotein (s-HDL) particle concentration in plasma measured by Ion Mobility Assay at Week 24 For more information on the measurement used please refer to this article: https://doi.org/10.1002/alz.12649
No measurements were reported for this outcome.
Mean percent change in cholesterol efflux capacity in CSF from screening (V1) to week 24 (V6)
| percent change from screening | 10mg Obicetrapib Tablets |
|---|---|
| Mean Percent Change in Cholesterol Efflux Capacity in Cerebrospinal Fluid (CSF) | 1.9 ± 24.1 |
Collected over From first dose of study drug through Week 24.5. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 10mg Obicetrapib Tablets | 0/13 (0%) | 0/13 (0%) | 9/13 (69.2%) |
| Event | 10mg Obicetrapib Tablets |
|---|---|
| HeadacheNervous system disorders | 2/13 |
| Normocytic anemiaBlood and lymphatic system disorders | 1/13 |
| Angina pectorisCardiac disorders | 1/13 |
| Benign paroxysmal positional vertigoEar and labyrinth disorders | 1/13 |
| ConstipationGastrointestinal disorders | 1/13 |
| Loose stoolsGastrointestinal disorders | 1/13 |
| ObstipationGastrointestinal disorders | 1/13 |
| Reflux esophagitisGastrointestinal disorders | 1/13 |
| Unilateral leg swellingGeneral disorders | 1/13 |
| Covid-19Infections and infestations | 1/13 |
Baseline Population is defined as all participants who received at least one dose of study drug.
| Age, Continuous(years) | 10mg Obicetrapib |
|---|---|
| Mean | 64.5 ± 6.2 |
| Sex: Female, Male(Participants) | 10mg Obicetrapib |
|---|---|
| Female | 12 |
| Male | 1 |
| Race and Ethnicity Not Collected(Participants) | 10mg Obicetrapib |
|---|
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Plan to share: No
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NewAmsterdam Pharma