Evaluating the effects of obicetrapib and evolocumab on Lp(a) levels
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
This study is testing if a new medication called obicetrapib, alone and with another drug called evolocumab, can lower Lp(a) levels in people who have high Lp(a).
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 69 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | NewAmsterdam Pharma Industry-sponsored |
| Drugs / interventions | evolocumab |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06496243 on ClinicalTrials.gov |
What this trial studies
This open-label, 16-week trial aims to assess the impact of obicetrapib, both alone and in combination with evolocumab, on lipoprotein(a) [Lp(a)] levels in patients with elevated Lp(a). Participants will undergo baseline Lp(a) testing and receive daily doses of obicetrapib for the first 8 weeks, followed by a combination treatment of obicetrapib and evolocumab for the next 8 weeks. Lp(a) levels will be re-evaluated at the end of each treatment phase to determine the effectiveness of the interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with Lp(a) levels greater than 50 mg/dL and LDL-C levels above 70 mg/dL.
Not a fit: Patients with poorly controlled diabetes or recent cardiovascular events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for patients with elevated Lp(a) levels, potentially reducing cardiovascular risk.
How similar studies have performed: While the specific combination of obicetrapib and evolocumab is novel, similar studies targeting Lp(a) reduction have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania
- UPenn — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Ashley Walker
- Email: ashley.walker@newamsterdampharma.com
- Phone: 919 641 5724
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.