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Charles Perkins Centre

The Boden Initiative Clinical Trials

Evaluating treatments and interventions for obesity and related metabolic problems, especially diabetes
We can't do research without your help. If you need help losing weight, preventing or managing Type 2 Diabetes, you may be eligible to participate in a clinical trial at the University.

Clinical trials at the Boden Initiative focus on evaluating treatments and interventions for obesity and related metabolic problems, especially diabetes. 

People who are accepted into a trial receive free medical care, advice and counselling from a range of health professionals and dieticians as well as regular monitoring. Trial participants are reimbursed for travel expenses incurred.

With no obligation, please contact us for more information or register your interest to participate using the form on the right of this page.

T 02 8627 0101
clinicaltrials.boden@sydney.edu.au

Current clinical trials

We are currently recruiting for the following clinical trials.

This study is recruiting participants with Congenital Adrenal Hyperplasia.  Participants will receive the investigational medication (to reduce excessive hormone production) or placebo for the first 12 weeks, following which all participants will receive the experimental medication for a further 58 weeks. Participants will attend visits at the Charles Perkins Centre every 4-6 weeks for the first 24 weeks and then every 6-12 weeks (parking or travel reimbursement is provided). 

Inclusion criteria:

  • age ≥ 18
  • classic Congenital Adrenal Hyperplasia.

This study is sponsored by Spruce Biosciences, California and has been approved by the Ethics Review Committee (RPAH Zone of the Sydney Local Health District.

This study is recruiting participants with Congenital Adrenal Hyperplasia. Participants will receive the investigational medication (to reduce excess hormone production) or the placebo for the first 24 weeks, following which all participants will receive the investigational medication for a further 52 weeks. Participants will attend visits at the Charles Perkins Centre every 2-6 weeks during the first 24 weeks and then every 2-3 months.

Inclusion criteria:

  • age ≥ 18
  • classic Congenital Adrenal Hyperplasia.

This study is sponsored by Spruce Biosciences, California and has been approved by the Ethics Review Committee (RPAH Zone of the Sydney Local Health District).

This study is recruiting people with a BMI >27kg/m2 and risk factors for heart disease including high blood pressure, elevated cholesterol, pre-diabetes, and kidney disease. People who have experienced cardiovascular disease such as heart attack, stroke and peripheral vascular disease are also eligible. The purpose of the study is to determine if the study medication is better than placebo in reducing obesity-related disease and death in adults living with overweight and obesity.

Participants will receive the investigational medication (called Tirzepatide) or placebo and will engage in a lifestyle program aimed at making healthful changes to diet and physical activity.

This is an event-driven study which means the study duration will be approximately 5.5 years. Participants will attend visits at the Charles Perkins Centre once a month for the first 6 months and then once every 3 months for the remainder of the study.

Inclusion criteria:

AND 

  • Age ≥40 years old with a history of cardiovascular disease such as heart attack, stroke and peripheral vascular disease

OR

  • Women aged ≥55 years old and men aged ≥50 years old with risk factors for cardiovascular disease (tobacco use, high blood pressure, high cholesterol, prediabetes, kidney disease)

The study is sponsored by Eli Lilly and has been approved by the Ethics Review Committee (RPAH Zone of the Sydney Local Health District).

PreBabe is a world-first clinical trial exploring how losing weight prior to pregnancy can improve the long-term health of mothers and babies. Women in Sydney and Newcastle planning a pregnancy are invited to join the PreBabe Trial. We are looking for 2,200 women to take part over the next three years.

Inclusion criteria:

  • Women with a BMI > 25, aged 18 to 40 and thinking of becoming pregnant soon are encouraged to register their interest

Participating women will be offered a free 10-week weight loss program as part of the trial. PreBabe will test two different approaches to losing weight prior to pregnancy to see which has the best short and long-term results for women and babies. Both weight loss programs are safe, supported by a clinical team, and designed to be followed for 10 weeks prior to trying to get pregnant.

The study will generate new knowledge for researchers and healthcare providers to better understand which weight loss approach can best help women with overweight who want to become pregnant. 

Clinical trials group

Leader

  • Associate Professor Tania Markovic, Clinical Associate Professor, Sydney Medical School; Boden Collaboration; Director, Metabolism & Obesity Service (SLHD)

Researchers

  • Dr Nick Fuller, Industry Program Leader
  • Dr Kyra Sim, Manager, Childhood Obesity Prevention and Management, Dietitian (SLHD)
  • Associate Professor Samantha Hocking, Diabetes NSW & ACT; Deputy Head, Metabolism & Obesity Service (SLHD); President, National Association of Clinical Obesity Services
  • Tegan Picone, Clinical Trials Co-ordinator
  • Chelsea Hendy, Research Assistant
  • Jessica Burk, Research Assistant