phase III
enrolling now

The Once-Weekly Self-Injectable Pen for Heart Health

For adults aged 45 and older with a BMI of 27 or higher and a diagnosis of heart health conditions, including prior heart attack, peripheral artery disease, or prior stroke. Conducted at our Sippy Downs clinic on the Sunshine Coast.
Age 45+
day visits
Up to $2880
About this trial

A new weekly injection to help heart health and support weight management

Atherosclerotic cardiovascular disease (ASCVD) occurs when fatty plaques, made of cholesterol and inflammatory cells, build up inside the arteries, causing them to narrow or harden and restricting blood flow to vital organs such as the heart and brain. Over time, these plaques can lead to heart attack, angina, stroke, or other serious cardiovascular events, often without early warning signs. ASCVD includes conditions such as coronary heart disease, heart attack, stroke, and peripheral vascular disease.

Cardiovascular disease remains one of Australia's largest health burdens. 1 in 6 Australians, over 4.5 million people, are living with CVD, and it accounts for 1 in 4 deaths nationally, around 120 every day. Around 600,000 Australian adults are living with coronary heart disease - the most common form of ASCVD. For many people, managing cardiovascular disease alongside excess weight adds further complexity to their long-term health.

This trial is evaluating whether a new once-weekly self-injectable treatment can help reduce the risk of serious cardiovascular events while also supporting weight management in people with established ASCVD, offering a potential new approach for those managing both conditions at the same time.
There is a 50% chance of receiving the investigational treatment rather than a placebo in the heart health and weight trial. Participants continue their normal treatment and care as directed by their doctor throughout the trial. The investigational medicine is an add-on therapy, not a replacement. Type 2 diabetes patients are eligible if their treatment has been stable for at least 3 months.
Eligibility

Do you qualify for an heart health study?

Aged 45 or older
BMI of 27 or higher (check this link to calculate your BMI)
Diagnosed with one of the following: prior heart attack, peripheral artery disease (PAD), or prior stroke
Type 2 diabetes patients are eligible if their treatment has been stable for at least 3 months
What's involved

Commitment and procedures

Visit type
day visits
total visits
25
duration
4 years
treatment
Auto-injector pen

procedures

Physical examination and vital signs
Blood and urine sample collections
ECG (electrocardiogram)
Pregnancy test (if applicable)
Eye examination (diabetics participants only)
Self-injectable pen training and administration

treatment design

Eligible participants will be randomly assigned to receive either the investigational once-weekly self-injectable treatment or a placebo, with a 50% chance of receiving either. The injection is self-administered once weekly into the thigh, abdomen, or upper arm, with training provided by the clinical team. 

Participants continue their normal treatment and care as directed by their doctor throughout the trial. Participants will attend 25 clinic visits at our Sippy Downs clinic over 4 years. All procedures will be explained clearly, and participants can ask questions at any time.
More information

Have questions? We're here to help.

Contact our recruitment team directly; they're happy to answer any questions before you apply for the heart health and weight trial. Please do not send personal medical information by email.
Phone
+07 5409 8640
Hours
Mon–Fri, 8am–5pm
Trial at a glance
Status
enrolling
Phase
phase III
Therapeutic Area
Ages
45+
Duration
4 years
Visits
25 visits
Location
Sippy Downs clinic
PROTOCOL
NN9490-8037
Reimbursement
Up to $2880

Ready to check your eligibility?

It takes less than 2 minutes to complete our heart health trial.
Apply for this trial →
We won't share your details with third parties.
This trial has been reviewed by an independent human research ethics committee.

Not the right trial?

Browse all trials

Form submission notice

If you apply for a trial and receive an error message, don't worry, we have received your application. We’re working to resolve this now.

UniSC Clinical Trials South East Queensland
South East Queensland's most active clinical research network, connecting communities, clinicians and global sponsors since 2015.
Copywriting © 2026 UniSC Clinical Trials
envelopephone-handsetmap-marker
linkedin facebook pinterest youtube rss twitter instagram facebook-blank rss-blank linkedin-blank pinterest youtube twitter instagram