What this study is
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
What's being tested
- obicetrapib 10 mg + obicetrapib/evolocumab 140 mg Q 2 weeks
Intervention · DRUG
10 mg obicetrapib for 8 weeks followed by 10 mg obicetrapib/ 140 mg evolocumab (every 2 weeks) combination for 8 weeks
Study details
- 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
- Sponsor
- NewAmsterdam Pharma
- Conditions
- Dyslipidemias
- Enrolling
- 69 people
- Starts
- 2024-12-02
- Est. completion
- 2027-02
- Design
- Open-label, sequential groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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)
You can't join if
- HbA1c>=10 or FPG >=270 mg/dL
- CV events within 3 months of screen
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUPenn
Philadelphia, Pennsylvania, United States
- Archna Bajaj · Principal investigator
Recruiting
Study team
Sponsor
NewAmsterdam Pharma
Study ID TA-8995-206
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.