Effect of Alirocumab on Lipoprotein(a) (Lp(a)) Metabolism in Subjects with Moderate to High Risk of Heart Disease

Phase 2

Completed

• Conditions: Cardiovascular Disease (CVD); Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12617000401358
• Lead Sponsor: inear Clinical Research Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-17
• Study Completion: 2019-07-08
• Last Update Posted: 2019-10-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1.Caucasian and non-caucasian
2.Aged 18-75 years inclusive, male or female
3.Men and women on maximally tolerated high potency stains with elevated plasma Lp(a) concentrations [equal or more than 0.6 g/L] who have moderate-to-high cardiovascular disease (CVD) risk based on the Australian National Vascular Disease Prevention Alliance (NVDPA) Guidelines for management of absolute cardiovascular disease risk (including documented and/or family history of CVD or CVD risk equivalent including documented history of other clinical atherosclerotic disease(s) i.e. peripheral artery disease, clinically significant carotid artery disease, abdominal aortic aneurysm)
For the purposes of this project, documented CVD includes: documentation of a history of myocardial infarction [MI], coronary artery bypass graft surgery, percutaneous transluminal coronary angioplasty, or alternative revascularization procedure [e.g. atherectomy/stent], coronary artery disease documented by exercise or non-exercise stress test and/or clinically significant carotid artery disease documented by angiography, carotid ultrasonography, or any other accepted cardiac computed imaging technique
4.Participants will be of stable weight and maintaining a guideline recommended heart healthy diet (lower saturated fat, higher complex carbohydrate and lower salt content)
5.Participants will be on concurrent aspirin therapy, 75 mg – 300 mg orally once daily, for at least one week prior to Day 1 and continue for the duration of the study

Exclusion Criteria

1.Cardiovascular events in the past 6-months
2.History of venous thromboembolism and/or pulmonary embolism
3.Low-density lipoprotein cholesterol equal to or less than 1.0 mmol/L
4.Participation in another clinical trial involving a PCSK9 monoclonal antibody
5.Type 1 Diabetes Mellitus
6.Type 2 Diabetes Mellitus
7.Secondary hyperlipidaemia
8.Renal disease (creatinine >130 micro mol/L, including proteinuria, nephrotic syndrome)
9.Hepatic dysfunction (AST or ALT > 5x ULN)
10.Current anaemia or past history of significant anaemia e.g. haemolytic anaemia (Hb must be >125 g/L to be eligible)
11.Haematological disorders
12.Recent history of haemorrhage or donation of blood within the 3 months prior to screening
13.Women who are on hormone replacement therapy
14.Positive laboratory screening result for HIV, Hepatitis B or C
15.Current smoker
16.Psychiatric illness (participants who are stable on treatment for depression or anxiety are eligible)
17.Alcohol excess (>30 g/day)
18.Hypersensitivity or contraindicating co-morbidities to Aspirin
19.Lipid-lowering therapies that are known to have major effects on plasma Lp(a) levels e.g. niacin, high dose fish oils (equal or more than 4 g/day)
20.Active auto-immune or vasculitic disorders
21.Likelihood of not completing the study as per judgement of investigator
22.Of Japanese and South East Asian decent
23.Women who are pregnant and / or not using a highly effective method of contraception
24.People highly dependent on medical care (i.e. unstable clinical status requiring frequent ambulatory or inpatient care)
25.People with a cognitive impairment, an intellectual disability or a mental illness
26.People whose primary language is other than English (LOTE) who will not be able to provide informed consent
27.Known hypersensitivity to monoclonal antibody or any component of the drug product
28.Donated blood within 3 months prior to Day 1

Study & Design

• Study Type: Interventional
• Study Design: Not specified