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

Research Centre: Flinders University ; Woolcock Institute of Medical Research ; CORE Research Group ; Southern Adelaide Diabetes & Endocrine Services ; Austin Health Centre for Research and Education in Diabetes and Obesity
Location: Laffer Drive, Bedford Park SA 5042, Australia ; 2 Innovation Road, Macquarie Park 2113 ; 1/18 Kilroe St, Milton QLD 4064, Australia ; Southern Adelaide Diabetes & Endocrine Services Marion GP Plus Health Care Centre, Level 1, 10 Milham Street, Oaklands Park 5046 ; Level 1, Centaur Building, Heidelberg Repatriation Hospital 300 Waterdale Rd, Heidelberg Heights, Victoria 3081 Australia
Lead Researcher: Professor Danny Eckert ; Professor Ron Grunstein ; Associate Professor David Colquhoun ; Professor Stephen Stranks ; Professor Elif Ekinci
HREC: This study has been reviewed and approved by the Monash Human Research Ethics Committee ; Monash Health Institutional Review Board

Are you living with type 2 diabetes and struggling with obesity or being overweight? A new research study might offer hope. This study aims to explore an investigational treatment. Designed to complement a healthy lifestyle, it aims to assist adults in managing obesity, type 2 diabetes, and sleep apnoea. The study’s core focus is to assess the effectiveness and safety of this investigational treatment. This research focuses on comparing investigational medication with a placebo to see how it helps people manage both type 2 diabetes and weight issues. It’s all about understanding if this investigational treatment can assist in tackling obesity while dealing with diabetes and sleep apnoea. Your participation in this study could assist in the quest for more effective solutions.

Interested? Take the online questionnaire to see if you qualify!

• Participants may receive an investigational treatment for type 2 diabetes and obesity. The randomisation will have 3 groups on differing doses of the study medication and 1 group on placebo (1:1:1:1). This means that there is a 75% chance of participants receiving the study medication and a 25% chance of them receiving the placebo.
• Participants will receive lifestyle counselling by a dietician throughout the study.
• Participants will be compensated for their travel costs and reasonable out of pocket expenses.
• Participants may experience improvements in their sleep apnoea and type 2 diabetes symptoms. They may also experience improvements in how they manage their weight.
• Participants will be contributing valuable information that may benefit those with type 2 diabetes, obesity, and sleep apnoea 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 and above who are diagnosed with type 2 diabetes
• Must have obesity or be overweight, with a BMI of 27 or higher
• Must be willing and able to use effective contraception
• Must not be pregnant or planning to be pregnant within the following year
• Can be on CPAP therapy for sleep apnea or untreated
• Must not have had a prior or planned surgical treatment for obesity
• Must not be taking insulin regularly to treat diabetes
• Must not have had a diagnosis of cancer in the last 5 years (cervical cancer and skin cancer okay)
• Must not have had a significant cardiovascular event within 90 days prior to screening (Visit 1)
• Must not have a history of chronic or acute pancreatitis
• Must not have acute or chronic hepatitis
• Must not have known allergies or intolerance to GLP-1 receptor agonists, GIP/GLP-1 receptor agonist (e.g., Saxenda, Ozempic, Wegovy, Mounjaro)
• Must not have participated in another clinical study involving an investigational product within the past 90 days
• Must be able to attend 23 study visits and 2 overnight sleep studies at the research site over approximately 89 weeks

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

• Participants will be asked to undergo a screening period lasting approximately 5 weeks with 2 planned visits and an overnight sleep study to assess study eligibility.
• Participants will be asked to experience a study treatment period spanning about 1 year and 6 months with 23 planned visits and 2 overnight sleep studies, receiving the study medication and self-administering weekly injections via a prefilled pen.
• Participants will have the option to participate in certain visits through telehealth (phone or video calls).

Flinders University
For over five decades, Flinders University has stood as a hub of remarkable accomplishments, marked by pioneering research, exceptional teaching, and significant contributions to the communities it serves. The institution’s ethos revolves around the belief that inspiration fuels innovation. Firmly connected through a robust network of external partnerships, the university remains dynamic, breaking barriers to devise innovative solutions that create positive impacts, change lives, and aspire to transform the world.

Woolcock Institute of Medical Research
The Woolcock Institute of Medical Research is a not-for-profit research institute. It aims to improve the quality of life for people affected by sleep and breathing disorders.

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.

Southern Adelaide Diabetes & Endocrine Services
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.

Austin Health Centre for Research and Education in Diabetes and Obesity
The Austin Health Centre for Research and Education in Diabetes and Obesity is located at the Repatriation Hospital Campus of Austin Health. It is tiered within the Medical Services Division. CREDO has a strong and successful history in conducting numerous clinical trials in metabolic disorders, with a majority of trials focusing on diabetes and obesity

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.