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The goal of this open label 16 week trial is to evaluate Lp(a) levels for patients with elevated Lp(a) being treated with obicetrapib and obiceptrapib/evolocumab
Patients will:
Have baseline Lp(a) tested at randomization Take 10mg/dL obiceptrapib daily for 8 weeks and have Lp(a) tested at Week 8 Take 10 mg/dL obicetrapib daily/evolocumab 140 every other week for 8 weeks and have Lp(a) retested at Week 16
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| obicetrapib/evolocumab combination | Experimental | obicetrapib 10 mg/dL daily for 8 weeks followed by obicetrapib 10 mg/dL daily + evolocumab 140 mg/dL every other week for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| obicetrapib 10 mg + obicetrapib/evolocumab 140 mg Q 2 weeks | Drug | 10 mg obicetrapib for 8 weeks followed by 10 mg obicetrapib/ 140 mg evolocumab (every 2 weeks) combination for 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of evolocumab in combination with obicetrapib on lipoprotein (a) (Lp[a]). | Lp(a) change on combination therapy | 16 weeks from baseline; 8 weeks on combination therapy |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of obicetrapib alone on Lp(a). | Lp(a) change on obicetrapib | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley Walker | Contact | 919 641 5724 | ashley.walker@newamsterdampharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPenn | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C577155 | evolocumab |
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8 weeks on 10 mg daily obicetrapid followed by 8 weeks on obicetrapib 10 mg daily/Repatha 140 mg SC every 2 weeks combination therapy
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