SEMAGLUTIDE for Schizophrenia spectrum disorders|Obesity|Prediabetes

Inclusion criteria

• {"criterion_text":"- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, also including activities to determine suitability for the trial as for example the screening for eligibility.\n- Men or woman aged between 18 and 70 years, both years included, at the time of signing informed consent.\n- BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with the presence of prediabetes determined with either fasting plasma glucose (FPG) between 5.6 and 6.9 mmol/l and/or HbA1c between 39-47 mmol/mol measured on two occasions at least 24 hours apart. These measures will be done at the V1 and the V2 visit, or alternatively a measurement of FPG or HbA1c within the borders of prediabetes performed in the regular clinical treatment during last 2 weeks before screening can be used as the first of the two occasions.\n- A diagnosis within the schizophrenia-spectrum according to International classification of diseases version - 10 (ICD-10): F 20, F 22, F 23, F 25, F 28, F 29.\n- AP drug use for at least 3 weeks prior to starting study medication and a treatment plan/recommendation for further AP drug use for at least the next 6 months. Antipsychotic drug discontinuation during the trial will not result in exclusion from further participation in the study."}

Exclusion criteria

• {"criterion_text":"- With relation to glycemic regulation: a.\tType 1 or Type 2 diabetes present or in history. b.\tHbA1c >48 mmol/mol. c.\tLatent autoimmune diabetes in adults (LADA). d.\tTreatment with a GLP-1 receptor agonist last 3 months before screening. e.\tTreatment with insulin last 3 months before screening. f. Treatment with metformin last 4 weeks before drug initiation.\n- Clearly disturbed thyroidal function as in an untreated hypo- or hyperthyroidism.\n- Surgical treatment to reduce weight last 6 months before screening, or planned surgical treatment to reduce weight.\n- Safety criteria: a.\ta personal or family history of medullary thyreoid cancer or multippel endokrin neoplasi 2 (MEN 2). b.\tA history of pancreatitis during the last 12 months before inclusion. c.\tA history of myocardial infarction/instable angina/stroke during the last 12 months before inclusion. d.\tA prior serious hypersensitivity reaction to semaglutide or to any of the excipients or otherwise as specified in the SPC of Wegovy. e.\tA history of anorexia nervosa defined: a specialist diagnosed anorexia nervosa of ICD-10 F50.0 or F50.1 last ten years before randomization. f.\tWoman of childbearing potential (WOCBP) who are not using adequate contraceptive methods (ref. appendix 4, section 10.4.2). Contraception must be continued for 2 months after the stop of study medication. See exception clause in section 10.4.2.1. g.\tPregnant woman will, based on a positive pregnancy test, be excluded from participation. h.\tBreastfeeding. i.\tDisorders, unwillingness or inability which in the investigator’s opinion might jeopardize the subject’s safety or compliance with the protocol."}

Primary endpoints

• {"endpoint_text":"- The primary endpoints addressing the primary objective: change in body weight from baseline to week 26 of the study","definition_or_measurement_approach":"Change in body weight from baseline to week 26 (weight measured at baseline and at week 26); endpoint defined as change in body weight from baseline to week 26."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline at week 0 to week 26 in: o\tHbA1c (%, mmol /mol) o\tFPG (mmol/l) o\tFasting serum insulin (mIU/L) and insulin C peptid o\tLipids (mg/dL) \tTotal cholesterol \tHigh density lipoprotein (HDL) cholesterol \tLow density lipoprotein (LDL) cholesterol \tVery low density lipoprotein (VLDL) cholesterol \tFree fatty acids \tTriglycerides","definition_or_measurement_approach":"Laboratory measurements of HbA1c, fasting plasma glucose, fasting serum insulin and C-peptide, and lipid panel at baseline and week 26; change from baseline to week 26."}
• {"endpoint_text":"- Change from baseline at week 0 to week 26 in cognition as assessed by the Brief Assessment of Cognition in Schizophrenia (BACS)","definition_or_measurement_approach":"Cognitive function measured by BACS at baseline and week 26; change from baseline to week 26."}
• {"endpoint_text":"- Time (in days) until discontinuation of AP drug treatment as evaluated through interviews and the measurement of serum levels of antipsychotic drugs","definition_or_measurement_approach":"Time-to-event measured in days until discontinuation of antipsychotic (AP) treatment, assessed via participant interviews and serum antipsychotic drug levels."}
• {"endpoint_text":"- Change from baseline at week 0 to week 26 in the Stunkard scale","definition_or_measurement_approach":"Change in Stunkard scale score from baseline to week 26."}
• {"endpoint_text":"- The economic outcomes will be assessed in the following way: Analysis of incremental cost-effectiveness ratio (ICER) and a cost-utility analysis based on an well-validated instrument to capture changes in quality of life during the intervention period. These outcomes will also use register-data collected during the 12 months after participation in the RCT. Change in quality of life from baseline at week 0 to week 26 will be assessed by the Manchester Short Assesment of quality of life (MANSA).","definition_or_measurement_approach":"Health economic analysis including ICER and cost-utility analysis using quality-of-life instrument (MANSA) at baseline and week 26; register data used for 12 months post-participation."}
• {"endpoint_text":"- Change from baseline at week 0 to week 26 for waist and hip circumference, waist to hip ratio","definition_or_measurement_approach":"Anthropometric measurements (waist and hip circumferences) at baseline and week 26; compute change and waist-to-hip ratio change."}
• {"endpoint_text":"- Change from baseline at week 0 to week 26 in heart rate and blood pressure after 5 minutes at rest","definition_or_measurement_approach":"Vital signs (heart rate and blood pressure) measured after 5 minutes at rest at baseline and week 26; change from baseline to week 26."}
• {"endpoint_text":"- Proportion of participants with T2DM at week 26","definition_or_measurement_approach":"Proportion meeting criteria for type 2 diabetes mellitus at week 26 (based on glycemic measurements)."}
• {"endpoint_text":"- Change from baseline at week 0 to week 26 in the ratings of the Calgary Depression Scale for Schizophrenia (CDSS)","definition_or_measurement_approach":"Change in CDSS score from baseline to week 26."}

Norway

Earliest CTIS Part Ii Submission Date

02-10-2024

Latest Decision Or Authorization Date

06-05-2026

Processing Time Days

581

Number Of Sites

4

Number Of Participants

140

Primary sponsor

Full Name

Helse Bergen HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway

Third parties

• {"country":"Denmark","full_name":"Novo Nordisk A/S","duties_or_roles":"Providing study drug","organisation_type":"Pharmaceutical company"}