Triglycerides & Remnant Cholesterol Study

About the Study

Elevated triglycerides and remnant cholesterol are types of blood fats that can contribute to heart disease and metabolic issues. These circulate in the blood and, when elevated, can contribute to plaque buildup in the arteries, increasing the risk of heart attacks and strokes. Managing these levels is important for overall cardiovascular health, as they are linked to increased risk even when standard treatments are used.

This study is investigating whether an investigational antibody treatment can help lower elevated triglycerides and remnant cholesterol levels and reduce heart disease. The investigational treatment works by blocking a protein that slows down fat breakdown, potentially helping the body process and store fats more effectively.

Who is it for?

Participants may be eligible if they meet the criteria below:

• Aged 18–75
• Have recent high triglycerides ≥ 150 mg/dL (≥ 1.69 mmol/L)
• No Type 1 Diabetes
• No cancer diagnosis or treatments in the last 3 years
• No heart surgeries in the last 6 months
• Are using contraception (if applicable)
• Stable diet for the last 3 months
• Are comfortable with subcutaneous injections (pen injections)

Please note, participants will be asked to remain on their current medication for this trial.

What does participation look like?

If eligible, participants will be on study for a total of 44 weeks. There will be approximately 13 visits to the clinic during this time. The study will include a screening period (up to 8 weeks), a 24-week treatment period, and a 12-week safety follow-up period.

Clinic visits will range in time from 1–2 hours and will include several health assessments, including physical and vital signs examinations, ECGs, fasted and non-fasted blood tests, urine tests and subcutaneous injections. The doctor and study team will also discuss previous research on the treatment and will outline any possible risks or benefits of participating in the trial.

All visits will need to be done during our clinic business hours of 9am–5pm, Monday–Thursday. Most clinic visits will require participants to be fasting, so availability in the mornings is essential.

Participants will receive either the investigational treatment or placebo on a 3:1 ratio. These will be given via subcutaneous injection (pen injections) monthly over the 24-week treatment period. The study is blinded to participants, meaning they will not know whether they are receiving the investigational treatment or placebo to minimise any bias in the results.

There will be a reimbursement provided to eligible participants.