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Mixed Hyperlipidemia Studies Auckland

Marigold Mixed Hyperlipidemia Study

Auckland

Please note that this study has now closed. However, we encourage you to pre-register your interest for upcoming endocrinology and metabolic studies here.

Description

What to expect

Study details

Ages

18 years or older

Duration

12-14 clinic visits over 41 weeks **may include two 24-hour clinic stays (depending on study groups)

Compensation

You will be reimbursed for your time and travel costs

Eligibility Criteria

Adults aged 18+ with high cholesterol
Diagnosed or suspected mixed hyperlipidaemia
Fasting triglycerides ≥150 mg/dL
LDL-C ≥70 mg/dL OR non-HDL-C ≥100 mg/dL
Willing to maintain stable medications and diet
Not pregnant or breastfeeding
Able to attend visits over several months

Locations

Auckland

Description

Mixed hyperlipidaemia means having high cholesterol and high triglycerides, both of which increase the risk of heart disease. Standard treatments in New Zealand include lifestyle changes, statins, fibrates, omega-3 fatty acids, and dietary modification. Despite current treatments, many people continue to have elevated lipid levels. There is a need for better treatments and medications for people with high cholesterol and high triglycerides.

About the investigational medication
The investigational medication is a new RNA interference (RNAi) administered as a subcutaneous injection medication designed to lower both:

PCSK9 – a protein that increases LDL cholesterol
APOC3 – a protein that increases triglycerides

It aims to work by reducing the production of these proteins in the liver, which may help lower cholesterol and triglycerides.

What to expect

Study Aim

The main purpose of this study is to understand the safety, tolerability, and how the body responds to a potential new medication called, which is designed to lower both cholesterol and triglycerides.

Reason to participate
Your involvement may help researchers learn more about new treatments that could support people with high cholesterol and triglycerides in the future. Although you may not personally benefit, your participation contributes to medical research. Other reasons to participate include:

Regular health monitoring by highly experienced NZ Doctors and Nurses
Study care and medication are provided free of charge
Compensation for your time and travel expenses

About The Study

Taking part in the study involves firstly meeting with the research Doctor to find out more about your health and to see if the study is right for you. If you wish to take part and are eligible, we would like to see you for 12-14 clinic visits over approximately 41 weeks.

During visits, we conduct health checks that may include physical examinations and blood tests. We would like to ask you questions about your health and learn about your experience taking this medication. Other procedures may include:

Height/Weight/BMI
ECG’s
Drug screening
Hepatitis/HIV screening
Dietary counselling
Vital signs, urine samples, and fasted blood tests
Subcutaneous injection of the study drug
Biomarker sampling (if applicable)
Pregnancy testing (if applicable)

You would take the potential new medication or a placebo (looks like the investigational medicine but contains no active medication). About 75% of participants will receive the active study drug, and 25% will receive the placebo.

The study medication is administered as a subcutaneous injection (meaning it is injected under the skin with a very small needle, like common diabetes medications).

The study aims to investigate the study drug and determine whether it can successfully lower cholesterol, lipids, and triglycerides, and improve participants' general health markers.

Please note that this study has now closed. However, we encourage you to pre-register your interest for upcoming studies here.