The Boden Initiative Clinical Trials

This is a phase 3 trial investigating the effect of treatment with the experimental medication BI 456906 compared to placebo on cardiovascular health. BI 456906 activates the GLP-1 and glucagon receptors. These receptors are involved in regulation of blood glucose, appetite, fat break down and energy expenditure. Face to face study visits are monthly during the first 6 months and then once every three months. The total study duration will be around 114 weeks and may be a little longer or shorter.

You may be eligible if you fit the following criteria:

• adults with body mass index (BMI) of at least 27 kg/m
• you have experienced a cardiovascular event (eg stent or myocardial infarction) or have two risk factors (eg cholesterol, blood pressure, kidney disease)
• people currently taking other GLP-1 agonist medications for diabetes or obesity are not eligible to participate (eg Ozempic, Saxenda)
• people taking insulin are not eligible to participate.

Ethics Committee approval has been granted by Sydney Local Health District: SLHD (RPA Zone) – X23-0502

This study is recruiting participants with BMI ≥ 35kg/m² and a history of stroke, heart attack or peripheral vascular disease. Participants will receive the investigational agent or the placebo for at least 80 weeks. During this time participants will attend visits at the Charles Perkins Centre once every month (travel reimbursement is provided). Participants will be supported by accredited dietitians to make healthful changes to diet and physical activity.

Inclusion criteria:

• age ≥ 18 years
• BMI ≥ 35 kg/m²
• history of stroke, heart attack or peripheral vascular disease.

Ethics Committee approval has been granted by Sydney Local Health District [X23-0285].

This study is recruiting participants with BMI ≥ 25kg/m² and a diagnosis of type 2 diabetes. Most participants will receive semaglutide, cagrilintide or both, and 5.5 percent of participants will receive the placebo. Participants will not know which intervention (medication or placebo) they are receiving during the study. The study duration is 68 weeks and during this time participants will attend visits at the Charles Perkins Centre once every month.

Inclusion criteria:

• BMI ≥ 25 kg/m²
• diagnosed with type 2 diabetes
• currently take metformin, diaformin or diabex.

Ethics Committee approval has been granted by Sydney Local Health District [X23-0356].

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.

Ethics Committee approval has been granted by Sydney Local Health District [X21-0453].

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).

Ethics Committee approval has been granted by Sydney Local Health District [X21-0462].

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. 

Ethics Committee approval has been granted by Sydney Local Health District [2020/ETH02421].