A Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Olpasiran (AMG 890) (a GalNAc-conjugated Small Interfering RNA [siRNA]) in Subjects with Elevated Lipoprotein(a)

A Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Olpasiran (AMG 890) (a GalNAc-conjugated Small Interfering RNA [siRNA]) in Subjects with Elevated Lipoprotein(a) - 20180109 - OCEAN[a]-DOSE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52533

Enrollment

Registered

2020-06-26

Start date

2020-11-23

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerotic cardiovascular disease heart and blood vessel disease

Interventions

Subcutaneous administration of IP.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: -Subject has provided informed consent prior to initiation of any study specific activities/procedures. -Age 18 to 80 years -Fasting Lp(a) > 150 nmol/L during screening by central laboratory (approximately corresponds to > 60 mg/dL: note that molarity determines eligibility) -Atherosclerotic cardiovascular disease based on 1 of the following: • History of coronary revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) • Diagnosis of coronary artery disease with or without prior myocardial infarction • Diagnosis of atherosclerotic cerebrovascular disease • Diagnosis of peripheral arterial disease -For subjects receiving lipid-altering therapy (not required to participate in this study), lipid-altering therapy, including statin dose, must remain stable per local guidelines for >= 4 weeks prior to and during screening

Exclusion criteria

Exclusion criteria: Disease Related -Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) 3 x upper limit of normal (ULN), or total bilirubin (TBL) > 2 x ULN during screening -Inherited or other bleeding disorders -Recent major cardiovascular event (myocardial infarction, unstable angina, PCI, CABG, or stroke) within 6 months prior to day 1 -Planned cardiac surgery, PCI or carotid stenting, or planned major non-cardiac surgery during the study period Other Medical Conditions -Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 5 years prior to day 1 -Moderate to severe heart failure (New York Heart Association (NYHA) Functional Classification III or IV at day 1) or last known left ventricular ejection fraction = 160 mmHg or an average diastolic blood pressure of >= 100 mmHg at rest -Fasting triglycerides >= 400 mg/dL (4.5 mmol/L) during screening -Type 1 diabetes or poorly controlled (HbA1c >= 8.5%) type 2 diabetes mellitus as determined by central laboratory at screening Refer to page 31 of the protocol for more information.

Design outcomes

Primary

Measure	Time frame
• Percent change in Lp(a) from baseline at week 36	—

Secondary

Measure	Time frame
• Percentage change from baseline in: - Lp(a) at week 48 - LDL-C at week 36 and week 48 - ApoB at week 36 and week 48 • PK parameters for olpasiran including, but not limited to, maximum observed concentration (Cmax), and the area under the concentration time curve (AUC)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)