Please note: This trial has finished recruiting and is not accepting new participants.

Research Centre: Charles Perkins Centre, Royal Prince Alfred Hospital Clinic ; CORE Research Group ; Northern Beaches Clinical Research ; Southern Adelaide Diabetes & Endocrine Services and the Mount Gambier and Districts Health Service ; Barwon Health ; CDH Research Institute ;  Monash University Eastern Clinical Research Unit
Location: Johns Hopkins Dr, Camperdown NSW 2050, Australia ; 1/18 Kilroe St, Milton QLD 4064, Australia ; 201/694‑696 Pittwater Rd, Brookvale NSW 2100 ; Marion GP Plus Health Care Centre, Level 1, 10 Milham Street, Oaklands Park 5046 ; 276/300 Wehl St N, Mount Gambier SA 5290, Australia ; Adrian Costa Clinical Trials Centre Level 2, 73 Little Ryrie Street Geelong 3220 Victoria Australia ;  Unit 503/5 Emporio Pl, Maroochydore QLD 4558, Australia ; Eastern Health Clinical School, Arnold Street, Box Hill, Melbourne
Lead Researcher: Associate Professor Tania Markovic ; Associate Professor David Colquhoun ;  Dr. Richard de Solom ; Professor Stephen Stranks ; Dr. Shannon McCarthy ; Dr. Hans Seltenreich ; Professor Christ Gilfillan
HREC: This study has been reviewed and approved by the Monash Human Research Ethics Committee and Sydney Local Health District (RPA Zone) ; Monash Health Institutional Review Board

Is heart disease a part of your life or someone you care about? Your unique experiences hold the potential to illuminate the path of medical research. This study focuses on investigational treatment for adults navigating the challenges of type 2 diabetes, obesity, and heart-related issues. Joining this study is more than just addressing your condition; it’s a chance to be part of a community dedicated to finding answers. Your involvement is crucial in helping researchers understand how a potential treatment compares to a placebo for individuals dealing with obesity and heart-related issues. Together, we’re shaping the future of medical knowledge and advancing treatments for those facing these health challenges.

Interested? Take the next step and see if you qualify.

• Participants may receive an investigational treatment for weight loss in people with cardiovascular disease at no cost. They will be grouped into 2 groups – one of which receives a placebo, while the other receives the study medication.
• Participants may be reimbursed for any reasonable travel, parking, meals, and other expenses associated with the research study.
• Participants may experience improvements in their heart health.
• Participants will be contributing valuable information that may benefit those with obesity and heart-related issues in the future.
• Participants will be helping to advance medical research.

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
• Any information that you provide will be kept strictly confidential, except as required by law.
• Qualified health professionals will monitor your health as it relates to the study.

• Men and women aged 18 years old and above who have a history of myocardial infarction (heart attack), stroke, or narrowing or blockage of vessels that carry blood from the heart to the legs
• Must have a BMI of 35 kg/m² and above
• Must have a history of at least 1 self-reported unsuccessful dietary effort to reduce their body weight
• Must be diagnosed with type 2 diabetes
• Must not have taken any weight loss drugs, including over-the-counter medications, within 90 days (3 months) before screening
• Must not have undergone or have plans for surgical treatment to address obesity
• Must not be diagnosed with type 1 diabetes
• Must be diagnosed with type 2 diabetes
• Must not have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
• Must not be diagnosed with pancreatitis
• Must be able to attend monthly visits at the research site over approximately 113 weeks (26 months or approximately 2 years). They will also have the option to attend telehealth (remote) visits during the study.

The study team will explain the research in its entirety but some details are:

• Participants will be asked to receive lifestyle counseling, including advice on healthy food choices and setting physical activity goals, throughout the study.
• Participants will be asked to follow fasting instructions for at least 8 hours before office visits, with additional blood glucose monitoring and diabetes self-management training for participants with diabetes.
• Participants will be asked to learn and adhere to proper study medication injection techniques, including self-injection or assistance if needed, using a new autoinjector for each injection.
• Participants will begin the study with a 5-week screening period. Upon entering the treatment phase, there will be a 16-week ramp-up period during which the amount of study drug is gradually increased to aid the body in acclimating to the treatment. Once participants reach a stable dosage of either 9 mg or 12 mg of the study medication or placebo, the treatment will proceed for an additional approximately 88 weeks, totaling a treatment duration of approximately 104 weeks. Throughout this period, participants will be required to take the study medicine for approximately 2 years. It is important to note that the study treatment period may extend beyond 104 weeks until all necessary data has been collected by the researchers.

Charles Perkins Centre, Royal Prince Alfred Hospital Clinic
The Charles Perkins Centre is a multidisciplinary research centre committed to improving global health. Their unique, complex-systems approach allows them to bring together researchers in unexpected research collaborations.

CORE Research Group
CORE Research Group is owned and run by a consultant cardiologist and has successfully run clinical trials for almost 30 years. We run clinical trials in all areas of cardiology, lipids, diabetes, obesity, chronic kidney disease, non-alcoholic liver diseases, and internal medicine more generally.

Northern Beaches Clinical Research
Northern Beaches Clinical Research is dedicated to investigating the latest medical treatments and medical devices. Their goal is to gather unbiased data from voluntary research participants to aid in the development of new treatments. The centre prioritises ensuring that participants have a positive experience while contributing to research in a safe environment.

Southern Adelaide Diabetes & Endocrine Services and the Mount Gambier and Districts Health Service
The Southern Adelaide Diabetes and Endocrine Service (SADES) aims to deliver world-class clinical care, diagnostic services, teaching, and self-management education in Diabetes and Endocrine Disorders and to improve health through clinical and scientific research.

Barwon Health
Barwon Health is one of the largest and most comprehensive regional health services in Australia, providing care at all stages of life and circumstance. It provides services for everyone who needs care, regardless of their financial status or the location of their usual residence. As a regional health service, Barwon Health provides leadership and tertiary referral services across the Barwon South West region. Its local community is the G21 region which comprises the residents of the City of Greater Geelong, Colac Otway Shire, Golden Plains Shire, Borough of Queenscliffe, and Surf Coast Shire.

CDH Research Institute
CDH Research Institute Pty Ltd is committed to enhancing the health of the community by providing the highest quality medical research in our purpose-built facility located at Maroochydore on the Sunshine Coast. Their clinical trial staff is dedicated to delivering high-quality clinical research to foster novel medications over a diverse range of therapeutic areas for the benefit of their participants and ultimately the wider community.

Monash University Eastern Clinical Research Unit
Monash University’s Eastern Clinical Research Unit (ECRU) is part of the Eastern Health Clinical School. ECRU provides expert services in clinical trials for health organisations and the biotechnology sector, as well as support for independent principal investigator-driven studies. ECRU is involved in more than 150 active clinical trials, with more than 1,500 patients. A large team of over 40 clinical trial coordinators work with a variety of investigating groups.

Southern Adelaide Diabetes & Endocrine Services and the Mount Gambier and Districts Health Service
The Southern Adelaide Diabetes and Endocrine Service (SADES) aims to deliver world-class clinical care, diagnostic services, teaching, and self-management education in Diabetes and Endocrine Disorders and to improve health through clinical and scientific research.

Please note:
Due to the COVID-19 pandemic, the researchers would like to assure the participants that ensuring their and the study staff’s safety is of utmost importance.