CVOT-SURPASS: a trial for the prevention of cardiovascular events in Type II diabetes

This is a study to determine the efficacy of the experimental medication Tirzepatide (up to a maximally tolerated dose of 15mg/week) compared to Dulaglutide (1.5mg/week) for preventing major cardiovascular events in 12,500 participants over a timeframe of 5-6 years.

Participants will receive one of the interventions which is self-administered by subcutaneous injection (similar to insulin) once a week.

Participants will attend visits at the Charles Perkins Centre, Royal Prince Alfred clinic once a month for the first 6 months and then once every 3 months until the end of the study.

The objective of this study is to prove the non-inferiority and then superiority of Tirzepatide compared to Dulaglutide for preventing cardiovascular events such as myocardial infarction (heart attack) and cerebrovascular accident (stroke) in people who have established cardiovascular disease.

A secondary objective is to determine the effect of Tirzepatide on weight, HbA1c and blood lipids. A previous study comparing Tirzepatide to Dulaglutide (1.5mg) showed greater weight loss and reduction in HbA1 and serum triglycerides in participants treated with Tirzepatide.

All trial procedures and ongoing medical care are provided free to the participant, and any out of pocket expenses including travel will be reimbursed.

This study is being sponsored by Eli Lilly Australia Pty Ltd and conducted at the Boden Collaboration, The University of Sydney at the Charles Perkins Centre.

You may be eligible to participate in this study if you have:

• Age ≥ 40 years 
• Body Mass Index ≥ 25kg/m2
• Diagnosis of Type II diabetes
• Established cardiovascular disease (heart disease, cerebrovascular disease or peripheral vascular disease) 
• Hba1c 7-10.5%

If you are interested in assisting with this important and exciting area of research, please contact the study facilitator: 
on 8627 0101 or clinicaltrials.boden@sydney.edu.au