None listed
Conditions
Brief summary
The SWIFT study is a conducted under the SPIRIT Master Protocol (Adaptive Platform Trial) and is a randomised, placebo-controlled single-blind parallel-group trial: over a 24-week period . The primary objective in this study is to determine percentage change in body weight with 24-week treatment with subcutaneous tirzepatide versus placebo, adjusted for baseline weight for participants schizophrenia or schizoaffective disorder. Specifically, it is hypothesised those participants allocated to the active arm tirzepatide treatment will have a greater reduction of percentage body weight at week 24 compared to participants taking placebo.
Interventions
The study will include 106 individuals with schizophrenia or schizoaffective disorder who will be randomised to receive weekly injections of either subcutaneous Tirzepatide (titrated 2.5mg for 4 weeks, 5mg for 4 weeks, 7.5mg for 4 weeks, 10mg for the duration of the study) or placebo for 24 weeks in addition to their normal routine care. The tirzepatide will be administered by registered mental health clinical trial nurses, who will also monitor adherence. As schizophrenia and schizoaffective di
The study will include 106 individuals with schizophrenia or schizoaffective disorder who will be randomised to receive weekly injections of either subcutaneous Tirzepatide (titrated 2.5mg for 4 weeks, 5mg for 4 weeks, 7.5mg for 4 weeks, 10mg for the duration of the study) or placebo for 24 weeks in addition to their normal routine care. The tirzepatide will be administered by registered mental health clinical trial nurses, who will also monitor adherence. As schizophrenia and schizoaffective disorder are heterogeneous conditions, routine care will vary from individual to individual.
Sponsors
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
SWIFT inclusion criteria: 1. BMI equal or greater than 30 kg/m2 or BMI equal to or more than 27 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease, at baseline. 2. Has been on any antipsychotic medication for a period of at least 12 weeks. 3. Not currently on tirzepatide or any other GLP-1RAs.
Exclusion criteria
SPIRIT exclusion criteria: 1. Known allergies to any part of the formulation of the investigational product. 2. Any concomitant disease or condition that according to the investigator’s assessment makes the patients unsuitable for platform trial participation. 3. Inability to follow the study instructions and procedures. 4. People who are unable to understand or communicate in English. SWIFT exclusion criteria: 1. Known allergies to tirzepatide or other GLP-1RAs or any part of the formulation of the investigational product. 2. GLP-1RAs in the previous 6 months. 3. Obesity induced by other endocrinologic disorder (e.g., Cushing Syndrome, untreated Hypothyroidism). 4. 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 or self managed). 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. BMI <27kg/m2 at baseline. 11. Any concomitant disease or condition that according to the investigator’s assessment makes the patients unsuitable for trial participation. 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. 13. Diagnosis of Type 1 or Type 2 Diabetes mellitus as determined by fasting glucose and HbA1C.
Outcome results
None listed