Obesity is a common condition. It is not just a cosmetic concern but is linked to many serious health conditions such as diabetes, high blood pressure, high cholesterol, heart disease, stroke, sleep apnoea, cancer and associated complications of these conditions. Between 2022 and 2023, it was found that 2 in 3 Australian adults (65.8%) or approximately 13 million adults were living with overweight or obesity (Australian Institute of Health and Welfare, 2024).

Obesity is typically measured using Body Mass Index (BMI). There are many reasons why people have trouble losing weight, including environmental factors such as diet and physical activity, in addition to possible genetic or other physiological causes. Given the serious health risks associated with obesity, there is a need for effective and safe weight loss interventions that are more affordable and accessible than current options.

The investigational treatment is a weekly subcutaneous injection (given just under the skin).

Current weight loss treatments include lifestyle changes, surgical interventions, and pharmacological therapies. Lifestyle modifications such as improved diet and increased physical activity are foundational but often insufficient for achieving and maintaining significant weight loss. Surgical options are highly effective but come with high costs, invasive procedures, and limited scalability, making them inaccessible to many individuals. Pharmacological therapies are also highly effective but high cost and in limited supply.

We are seeking applications from people who:

• are aged 18 or older
• have a BMI equal to or more than 35
• do not have diabetes
• have previously tried to lose weight through diet and exercise without success

The trial will be conducted at our Brisbane or Morayfield clinic.

Participants will be reimbursed up to $2,600 for their time and inconvenience.

This trial has been reviewed and approved by an independent Human Research Ethics Committee.

What's involved?

This clinical trial will run for approximately one year and eight months. Participants will be asked to attend up to 22 clinic visits. The investigational medication involves a weekly self-administered injection, which participants will be trained to use safely and confidently. All participants will be randomly assigned to receive either the potential new investigational medication, a currently available treatment or placebo.

Procedures:

• Blood tests
• Urine tests
• Weight and waist measurements
• Blood pressure and heart rate checks
• Electrocardiogram (ECG)
• Sit-to-stand test (mobility and strength)
• Psychological questionnaires
• Diet and lifestyle support sessions
• Self-injection training and weekly medication administration

Where can I find more information?

More information can be requested by contacting the recruitment team on 07 5409 8640. Alternatively, the team will be more than happy to answer any questions you may have when they call.