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OpenTrials
Recruiting

NCT Number: NCT06496243

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

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

Recruiting

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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UPenn

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Archna Bajaj

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Repatha

Primary outcomes

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

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

    Lp(a) change on combination therapy

Secondary outcomes

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

    Time frame: 8 weeks

    Lp(a) change on obicetrapib

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Walker

CONTACT

[email protected]

919 641 5724

Sponsors and collaborators

Lead sponsor

NewAmsterdam Pharma

Industry

Registry information

Official study title

A Phase 2 Study to Evaluate the Effect of Obicetrapib Alone and in Combination With Evolocumab (Repatha®) on Lipoprotein (a) in Patients With Mild Dyslipidemia: The VINCENT Study

Acronym: VINCENT

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 11, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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