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

Phase 2RecruitingNCT06496243

NewAmsterdam Pharma69 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dyslipidemias

Interventions

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

10 mg obicetrapib for 8 weeks followed by 10 mg obicetrapib/ 140 mg evolocumab (every 2 weeks) combination for 8 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

UPenn

Philadelphia, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

To evaluate the effect of evolocumab in combination with obicetrapib on lipoprotein (a) (Lp[a]).

Lp(a) change on combination therapy

Time frame: 16 weeks from baseline; 8 weeks on combination therapy

Secondary Outcomes

To evaluate the effect of obicetrapib alone on Lp(a).

Lp(a) change on obicetrapib

Time frame: 8 weeks

Central Contacts

Ashley Walker

CONTACT

919 641 5724 ashley.walker@newamsterdampharma.com

Data from ClinicalTrials.gov

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