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

NewAmsterdam Pharma

Status and phase: Enrolling; Phase 2

Conditions: Dyslipidemias

Treatments: Drug: obicetrapib 10 mg + obicetrapib/evolocumab 140 mg Q 2 weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT06496243

TA-8995-206

Details and patient eligibility

About

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

Enrollment: 69 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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69 participants in 1 patient group

obicetrapib/evolocumab combination

Experimental group

Description:

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

Treatment:

Drug: obicetrapib 10 mg + obicetrapib/evolocumab 140 mg Q 2 weeks