Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study

Amgen

Status and phase: Completed; Phase 2

Conditions: Cardiovascular Disease

Treatments: Drug: Placebo; Drug: Olpasiran

Study type: Interventional

Funder types: Industry

Identifiers

NCT04270760

2019-003688-23 (EudraCT Number)

20180109

Details and patient eligibility

About

Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp[a]).

Enrollment: 281 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 to 80 years
• Lipoprotein (a) > 150 nmol/L
• Evidence of atherosclerotic cardiovascular disease

Exclusion criteria

• Severe renal dysfunction
• History or clinical evidence of hepatic dysfunction
• Malignancy within the last 5 years
• Currently receiving, or less than 3 months at Day 1 since receiving > 200 mg/day Niacin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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281 participants in 5 patient groups, including a placebo group

Arm 1 Olpasiran Dose 1

Active Comparator group

Treatment:

Drug: Olpasiran

Arm 2 Olpasiran Dose 2

Active Comparator group

Treatment:

Drug: Olpasiran

Arm 3 Olpasiran Dose 3

Active Comparator group

Treatment:

Drug: Olpasiran

Arm 4 Olpasiran Dose 4

Active Comparator group

Treatment:

Drug: Olpasiran

Arm 5 Placebo Dose 5

Placebo Comparator group

Treatment:

Drug: Placebo