Clozapine Obesity and Semaglutide Treatment (COaST)
Cadence-COaST (Clozapine Obesity and Semaglutide Treatment) is a clinical trial following on from the previous Cadence-CoMET clinical trial. The COaST trial will examine if incorporating an anti-diabetic medication, semaglutide alongside metformin can lead to a decrease in body weight in patients taking clozapine.
Despite their effectiveness in treating the psychotic symptoms of schizophrenia, antipsychotic medications lead to obesity, diabetes and cardiovascular disease. Antipsychotic induced weight gain is associated with decreased medication compliance, increased hospitalization and social care costs, stigma, and decreased quality of life. Metformin is increasingly used as a first line agent for antipsychotic induced weight gain, but has limited efficacy, only leading to around 3% body weight reduction. There is an urgent need for more efficacious cardiometabolic agents for people with schizophrenia.
To reduce the personal, social and economic burden associated with cardiometabolic disorders that may develop secondary to weight gain, it is of significant benefit to investigate novel methods of treating clozapine-associated obesity. To date, metformin and GLP-1RAs (GLP-1 Receptor Agonists) show the best promise for treatment of clozapine associated obesity.
However, weight loss associated with metformin is limited, and the current costs associated with GLP-1RAs may preclude their use as a first line treatment. Semaglutide is the first GLP-1RA available in a daily oral formulation and is well-tolerated. There is an urgent need for a stepped care trial of Semaglutide versus placebo for clozapine associated obesity that is inadequately responsive to metformin.
One hundred and twenty (120) participants will be recruited through mental health services (i.e. inpatient units, clozapine clinics and continuing care units) in three Queensland Hospital and Health Services: (a) Metro North HHS, (b) Metro South HHS and (c) West Moreton HHS.
The primary objective is to evaluate if 24 weeks treatment with semaglutide versus placebo will lead to significantly lower 24 week endpoint weight adjusted for baseline (ANCOVA).
The second objective is to determine if 24 week treatment of semaglutide versus placebo has comparative changes in rate of conversion to T2DM and development of the metabolic syndrome.
This research is headed by Professor Dan Siskind and funded through Metro South Program Grant. The Clinical Support Unit at QCMHR headed by Andrea Baker will coordinate the clinical trial.
This study is ongoing and looking for volunteers! If you would like to participate in this study,
Funded by
- Metro South Research Support Scheme
- NHMRC Investigator Grant
Project Team
Professor Dan Siskind, QCMHR, Coordinating Principal Investigator
Andrea Baker, Research Manager
