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| ID | Type | Description | Link |
|---|---|---|---|
| The NICE Study | Other Identifier | NewAmsterdam Pharma |
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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To determine the treatment effect with obicetrapib (10 mg) on the fractional catabolic rate (FCR) of apolipoprotein (apo) B100 in low-density lipoprotein (LDL).
The study population will comprise 20 adults, 18 to 75 years of age, with LDL-C level ≥ 100 and ≤ 190 mg/dL, and in generally good health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obicetrapib placebo | Placebo Comparator | identical matching placebo |
|
| Obicetrapib 10 mg | Experimental | 10 mg tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obicetrapib | Drug | 1 tablet daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment with obicetrapib (10 mg) on the fractional catabolic rate (FCR) of apolipoprotein (apo) B100 in low-density lipoprotein (LDL). | The mean differences (obicetrapib - placebo) in the LDL apoB100 FCR using the baseline measure (no study treatment) compared to the LDL apoB100 FCR of each variable following the Treatment Period. | 8-12 week |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment with obicetrapib (10 mg) on the production rate (PR) of apolipoprotein(a), or apo(a), in Lp(a). | The mean differences (obicetrapib - placebo) in the apo(a) in Lp(a) production rate using the baseline measure (no treatment) compared to the apo(a) PR obtained following the Treatment Period. | 8-12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment with obicetrapib (10 mg) on the FCR of total apolipoprotein (apo) B100 in plasma. | The mean difference (obicetrapib - placebo) on the FCR of total apolipoprotein (apo) B100 in plasma using the baseline measure (no treatment) compared to the FCR of apoliprotien (apo) B100 following the Treatment Period. | 8-12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Archna Bajaj, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Archna Bajaj, MD | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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This is a phase 1, single-site, double-blind, randomized, placebo-controlled, 2 period, fixed-sequence, pharmacodynamic study in healthy participants meeting the eligibility requirements. Participants will be randomized in a 1:1 ratio to either obicetrapib or matching placebo, and evenly distributed between treatment groups based on their Screening Lp(a) values; ≥ 30 mg/dL vs < 30 mg/dL. LDL-C levels ≥ 100 mg/dL and ≤ 190 mg/dL have been selected for this study as the target population as this is the population of patients targeted for treatment with obicetrapib as an adjunct to statin therapy.
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Double-blind