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Obicetrapib + Repatha for Dyslipidemia (VINCENT Trial)

Phase 2
Recruiting
Research Sponsored by NewAmsterdam Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks from baseline; 8 weeks on combination therapy
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study the levels of Lp(a) in patients with high Lp(a) who are receiving treatment with obicetrapib and a combination of obicetrapib and

Who is the study for?
This trial is for individuals with dyslipidemia, specifically those with triglycerides under 400 mg/dL, Lp(a) over 50 mg/dL, and LDL cholesterol above 70 mg/dL. It's not suitable for people who don't meet these blood lipid criteria.
What is being tested?
The study tests the effects of obicetrapib alone and combined with evolocumab on lowering Lp(a) levels in patients. Participants will take obicetrapib daily for eight weeks, then add evolocumab injections every two weeks for another eight weeks.
What are the potential side effects?
Potential side effects may include reactions at the injection site due to evolocumab, muscle pain or weakness, liver enzyme changes from obicetrapib use, and possible allergic reactions to either medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks from baseline; 8 weeks on combination therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks from baseline; 8 weeks on combination therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To evaluate the effect of evolocumab in combination with obicetrapib on lipoprotein (a) (Lp[a]).
Secondary study objectives
To evaluate the effect of obicetrapib alone on Lp(a).

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: obicetrapib/evolocumab combinationExperimental Treatment1 Intervention
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

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Who is running the clinical trial?

NewAmsterdam PharmaLead Sponsor
16 Previous Clinical Trials
13,866 Total Patients Enrolled
1 Trials studying Dyslipidemia
102 Patients Enrolled for Dyslipidemia
~20 spots leftby Oct 2025
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