NCT06496243PHASE2Recruiting

Impact of Obicetrapib and Obicetrapib Plus Repatha on Lp(a) Levels

NewAmsterdam Pharma

Start Date

12/2/2024

Completion Date

2/1/2027

Summary

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

Eligibility Criteria

Age Range: 18 years to 75 years

Inclusion Criteria: * Lp(a): \>=50 mg/dL (\>=125 nmol/L) for cohort 1 (FILLED) and Lp(a) \>= 20 mg/dL (\>= 50 nmol/L) to \<50 mg/dL (\< 125 nmol/L) for cohort 2 * LDL-C \>70 mg/dL * TG \< 400mg/dL (\<4.52 mmol/L) Exclusion Criteria: * HbA1c\>=10 or FPG \>=270 mg/dL * CV events within 3 months of screen

Interventions

DRUG

obicetrapib 10 mg + obicetrapib/evolocumab 140 mg Q 2 weeks

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Conditions

Dyslipidemias

Locations

UPenn

Philadelphia, Pennsylvania 19104

United States