2023-506109-20-00招募中3 期
An interventional, multi-center, randomized, double blinded, placebo controlled study to investigate semaglutide add-on treatment for metabolic control in antipsychotic-using patients (STABIL-NOR – study)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- The primary endpoints addressing the primary objective: change in body weight from baseline to week 26 of the study
研究概览
简要总结
To compare the effect of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo in patients with schizophrenia spectrum disorders and a BMI of equal to or above 30 kg/m2 or BMI equal to or above 27 kg/m2 in addition to prediabetes determined by FPG between 5.6 and 6.9 mmol/l and/or HbA1c between 39-47 mmol/mol (on two occasions at least 24 hours apart) on body weight.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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.
- •Men or woman aged between 18 and 70 years, both years included, at the time of signing informed consent.
- •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.
- •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
- •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.
排除标准
- •With relation to glycemic regulation: a. Type 1 or Type 2 diabetes present or in history. b. HbA1c >48 mmol/mol. c. Latent autoimmune diabetes in adults (LADA). d. Treatment with a GLP-1 receptor agonist last 6 months before screening. e. Treatment with insulin or other glucose-lowering drug(s) last 3 months before screening.
- •Thyreoid stimulating hormone (TSH) outside the normal range-Haukeland university hospital: 11-19 years: 0,51-4,30 mIU/L, >20 years: 0,40-4,50 mIU/L.
- •Medical or surgical treatment to reduce weight last 6 months before screening, or planned surgical treatment to reduce weight.
- •Safety criteria: a. a personal or family history of medullary thyreoid cancer or multippel endokrin neoplasi 2 (MEN 2). b. A history of pancreatitis during the last 12 months before inclusion. c. A history of myocardial infarction/instable angina/stroke during the last 12 months before inclusion. d. A prior serious hypersensitivity reaction to semaglutide or to any of the excipients or otherwise as specified in the SPC of Wegovy. e. A history of eating disorders defined: a specialist diagnosed eating disorder of ICD-10 F50 last ten years. f. Woman 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. g. Pregnant woman will, based on a positive pregnancy test, be excluded from participation. h. Breastfeeding. i. Disorders, unwillingness or inability which in the investigator’s opinion might jeopardize the subject’s safety or compliance with the protocol.
结局指标
主要结局
The primary endpoints addressing the primary objective: change in body weight from baseline to week 26 of the study
The primary endpoints addressing the primary objective: change in body weight from baseline to week 26 of the study
次要结局
- Change from baseline at week 0 to week 26 in: o HbA1c (%, mmol /mol) o FPG (mmol/l) o Fasting serum insulin (mIU/L) and insulin C peptid o Lipids (mg/dL) Total cholesterol High density lipoprotein (HDL) cholesterol Low density lipoprotein (LDL) cholesterol Very low density lipoprotein (VLDL) cholesterol Free fatty acids Triglycerides
- Change from baseline at week 0 to week 26 in cognition as assessed by the Brief Assessment of Cognition in Schizophrenia (BACS)
- Time (in days) until discontinuation of AP drug treatment as evaluated through interviews and the measurement of serum levels of antipsychotic drugs
- Change from baseline at week 0 to week 26 in the Stunkard scale
- 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).
- Change from baseline at week 0 to week 26 for waist and hip circumference, waist to hip ratio
- Change from baseline at week 0 to week 26 in heart rate and blood pressure after 5 minutes at rest
- Proportion of participants with T2DM at week 26
- Change from baseline at week 0 to week 26 in the ratings of the Calgary Depression Scale for Schizophrenia (CDSS)
研究者
Rune Andreas Kroken
Scientific
Helse Bergen HF
研究点 (4)
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