New Phase 3 clinical trial for people living with type 2 diabetes and with cardiovascular or chronic kidney disease
Cardiometabolic health in people living with type 2 diabetes
Cardiovascular disease (CVD) and type 2 diabetes continue to have a considerable impact on Australia’s healthcare system. Every day, 120 people will die from CVD, or one person every 12 minutes.[1] People living with type 2 diabetes have a higher cardiovascular morbidity and mortality and are disproportionately affected by CVD.
Approximately 65% of cardiovascular disease-related deaths occur in people with diabetes or pre-diabetes. [2] The mortality rate in people with type 2 diabetes almost doubles with the coexistence of CVD, resulting in an estimated 12-year reduction in life expectancy.[3]
Improving the cardiometabolic health of at-risk people living with type 2 diabetes is critical in minimising the burden of both conditions in Australia.
New metabolic and cardiovascular research program
Walski Clinical Research, a growing site research organisation in New South Wales, has recently initiated a new metabolic and cardiovascular research study for people living with type 2 diabetes.
The organisation is looking for partnering clinicians and nurses who have an interest in metabolic syndrome, diabetes, and cardiovascular or renal disease to help bring new potential treatments for obesity and cardiovascular disease to patients across Sydney.
Walski Clinical Research is conducting a clinical trial at its Northern Beaches clinical trial site in Brookvale and will be looking to expand the program and activate new studies in the coming months.
To learn more about the clinical trial or refer patients to the study, visit here.
Snapshot: The TRIUMPH-OUTCOMES study
TRIUMPH-OUTCOMES (J1I-MC-GZBO) is a phase 3, randomised, double-blind, placebo-controlled, event-driven study to investigate the effect of Retatrutide on the incidence of major adverse cardiovascular events and the decline in kidney function in participants with BMI ≥27 and atherosclerotic cardiovascular disease and/or chronic kidney disease.
The investigational product used in TRIUMPH-OUTCOMES, Retatrutide, is a novel synthetic molecule which shows potent action at the GIP, GLP-1 and glucagon receptors. Retatrutide is a novel synthetic GIP, GLP-1 and glucagon receptor agonist which is expected to deliver substantial body weight reduction as well as improved glucose homeostasis and reduction in insulin resistance, lipids, and blood pressure. The objectives of TRIUPMH-OUTCOMES are to demonstrate whether Retatrutide is superior to placebo in reducing the risk for major cardiovascular and/or kidney events.
Eligibility for study
- Aged ≥45 years
- BMI ≥27
- May have type 2 diabetes
- Cardiovascular disease and/or chronic kidney disease, including at least 1 of the following:
- Coronary artery disease
- Cerebrovascular disease
- Peripheral arterial disease
- Chronic kidney disease
About the research clinic
Based in Brookvale, Northern Beaches Clinical Research, is committed to researching the newest medical treatments and medical devices. Its aim is to collect unbiased data from voluntary research participants to help develop the latest treatments.
Registering your interest:
To learn more about the clinical trial or refer patients to the study, visit here.
Please note: This research is not specifically endorsed by Diabetes Australia, however has been reviewed by the Medical Education and Scientific Council (MESC).
[1] Australian Bureau of Statistics; 3303.0 – Causes of Death, Australia, 2021. https://www.abs.gov.au/statistics/health/causes-death/causes-death-australia/latest-release#australia-s-leading-causes-of-death-2021
[1] Baker IDI Heart and Diabetes Institute. Diabetes: The silent pandemic and its impact on Australia. Melbourne, Vic: Baker IDI Heart and Diabetes Institute, 2012. Search PubMed
[1] Cosentino F, Ceriello A, Baeres FMM, et al. Addressing cardiovascular risk in type 2 diabetes mellitus: A report from the European society of cardiology cardiovascular roundtable. Eur Heart J 2019;40(34):2907–19. doi: 10.1093/eurheartj/ehy677.[AF1]