None listed
Conditions
Brief summary
The study will be a randomised, placebo-controlled single-blind parallel-group trial; over a 36 week period. The primary objective in this study is to determine percentage change in body weight with 36 week treatment with subcutaneous semaglutide versus placebo, adjusted for baseline weight period for patients with schizophrenia or schizoaffective disorder. Specifically, it is hypothesised those participants allocated to the active arm semaglutide treatment will have a greater reduction of percentage body weight at week 36 compared to individuals taking placebo.
Interventions
Interventional
The study will include 80 individuals with schizophrenia or schizoaffective disorder who will be randomised to receive weekly injections of either 2.4mg subcutaneous semaglutide (titrated – 0.25mg for 4 weeks, 0.5mg for 4 weeks, 1.0mg for 4 weeks, 1.5mg for 4 weeks, 2.0mg for the duration of the study) or placebo for 36 weeks in addition to their normal routine care.
All unused supplies of study medication will be accounted for and documented by the designated Research Pharmacis
Interventional The study will include 80 individuals with schizophrenia or schizoaffective disorder who will be randomised to receive weekly injections of either 2.4mg subcutaneous semaglutide (titrated – 0.25mg for 4 weeks, 0.5mg for 4 weeks, 1.0mg for 4 weeks, 1.5mg for 4 weeks, 2.0mg for the duration of the study) or placebo for 36 weeks in addition to their normal routine care. All unused supplies of study medication will be accounted for and documented by the designated Research Pharmacist. Compliance with study medication will be documented at each visit by means of receiving the injection or refusing.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Healthy volunteers
No
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
Outcome results
None listed