The Boden Initiative Clinical Trials

This study is recruiting participants with obesity caused by damage to the hypothalamic region of the brain. Participants will receive the investigational medication (to reduce appetite) or the placebo for 36 weeks (we will not know whether you receive the active medication or placebo). During this time participants will attend visits at the Charles Perkins Centre once every two weeks (parking or travel reimbursement is provided). Participants will have the option to participate in the study for an additional 36 weeks during which time all participants will receive the ‘active’ medication.

This study is recruiting participants with Prader Willi Syndrome. Participants will receive the investigational medication (to reduce appetite) at one of three doses or the placebo for 16 weeks (we will not know whether you receive the active medication or placebo). During this time participants will attend visits at the Charles Perkins Centre once every two weeks. Participants may choose to continue in the study for an additional 36 weeks during which time all participants will take the investigational medication.

Inclusion criteria:

• aged 13-65 years inclusive
• BMI 27 to 60 kg/m2 for adults and ≥85th percentile for age and sex for adolescents
• if female, must not be able to bear children (for example, post-menopausal)
• consistent caregiver able to attend appointments.

This study is sponsored by Sanioma, Denmark 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 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 participants with Prader Willi Syndrome. Participants will receive the experimental medication (to reduce appetite) or placebo for 24 weeks (we will not know whether you receive active or placebo). The study duration is 36 weeks and during this time participants will attend 12 visits at the Charles Perkins Centre (parking or travel reimbursement is provided). 

This study is sponsored by Radius Pharmaceuticals, Boston and has been approved by the Ethics Review Committee (RPAH Zone of the Sydney Local Health District)

Inclusion criteria:

• aged 12 and 65 years inclusive
• same caregiver can complete questionnaires for entire study.