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

NCT ID: NCT06496243

Last Updated: 2025-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-02

Study Completion Date

2026-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Dyslipidemias

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Repatha

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NewAmsterdam Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UPenn

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ashley Walker

Role: CONTACT

919 641 5724

Other Identifiers

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TA-8995-206

Identifier Type: -

Identifier Source: org_study_id

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