Impact of Obicetrapib and Obicetrapib Plus Repatha on Lp(a) Levels
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: obicetrapib 10 mg + obicetrapib/evolocumab 140 mg Q 2 weeks.
- Who it may be relevant to
- Registry conditions: Dyslipidemias. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
Interventions
- 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
Primary outcome measures
- 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]
Secondary outcome measures (1)
- To evaluate the effect of obicetrapib alone on Lp(a). [Time frame: 8 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UPenn — Philadelphia
Identifiers
NCT: NCT06496243 · TA-8995-206