Clozapine Obesity and Semaglutide Treatment (COaST). A randomised controlled multi-centre trial of semaglutide versus placebo for people with schizophrenia on clozapine with obesity

Phase 2

Suspended

• Conditions: Schizophrenia; Obesity; schizoaffective disorder; metabolic syndrome; Mental Health - Schizophrenia; Diet and Nutrition - Obesity; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12621001539820
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-11
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1.Aged between 18 and 64 years (inclusive)
2.Fulfil the DSM-IV criteria practice for schizophrenia or schizoaffective disorder or bipolar affective disorder, based on the Diagnostic Interview for Psychosis (DIP)
3.BMI greater than or equal to 26kg/m2 and less than or equal to 40 at baseline
4.Have received oral clozapine for a period of at least 18 weeks
5.Have had less than 5% body weight increase or loss in the previous 3 months.
6.Agree to participate, have capacity to consent and are able to follow the study instructions and procedures.

Exclusion Criteria

1.Known allergies to Semaglutide or other GLP1 RA’s or any part of the formulation of the investigational product
2.Obesity induced by other endocrinologic disorder (e.g Cushing Syndrome, untreated Hypothyroidism)
3.Current use of any weight-lowering therapy including: pramlintide, sibutramine, orlistat, zonisamide, topiramate or phenteremine (either by prescription or as part of a clinical trial)
4.Diagnosis of Type 1 or Type 2 Diabetes mellitus as determined by a fasting glucose test and HbA1C
5.Participants treated with corticosteroids or other hormone therapy (except oestrogens or thyroxine) for greater than 10 days
6.Chronic kidney disease (eGFR<60mL/min)
7.History of medullary thyroid adenoma or carcinoma, and patients with or family history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
8.History of pancreatitis
9.Previous surgical treatment of obesity
10. Any concomitant disease or condition that according to the investigator’s assessment makes the patients unsuitable for trial participation
11.People who are unable to understand or communicate in English
12.For female participants, those currently pregnant, or planning to become pregnant or lactating or no acceptance to the use of effective contraception during the study period

Study & Design

• Study Type: Interventional
• Study Design: Not specified