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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Intervention Model Description
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
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
obicetrapib/evolocumab combination 		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
  • Drug: obicetrapib 10 mg + obicetrapib/evolocumab 140 mg Q 2 weeks
    10 mg obicetrapib for 8 weeks followed by 10 mg obicetrapib/ 140 mg evolocumab (every 2 weeks) combination for 8 weeks
    Other names:
    • Repatha

Recruiting Locations

UPenn
Philadelphia, Pennsylvania 19104

More Details

Status
Recruiting
Sponsor
NewAmsterdam Pharma

Study Contact

Ashley Walker
919 641 5724
ashley.walker@newamsterdampharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.