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

ConditionDyslipidemias

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorNewAmsterdam Pharma

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

HbA1c>=10 or FPG >=270 mg/dL

CV events within 3 months of screen

Trial design

Design model

Sequential

Treatments tested in this trial

obicetrapib 10 mg + obicetrapib/evolocumab 140 mg Q 2 weeks
Drug
10 mg obicetrapib for 8 weeks followed by 10 mg obicetrapib/ 140 mg evolocumab (every 2 weeks) combination for 8 weeks

Treatment groups

69 Participants

are divided into 1 treatment group

Group A: obicetrapib/evolocumab combinationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

To evaluate the effect of evolocumab in combination with obicetrapib on lipoprotein (a) (Lp[a]).

Lp(a) change on combination therapy

Time frame

16 weeks from baseline; 8 weeks on combination therapy

Secondary outcomes

To evaluate the effect of obicetrapib alone on Lp(a).

Lp(a) change on obicetrapib

Time frame

8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NewAmsterdam Pharma

Lead sponsor

Source ClinicalTrials.gov

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