The Semaglutide add-on treatment for metabolic control in antipsychotic-using patients (STABIL-NOR – study).
- Conditions
- Drug induced weight gain from anti-psychotic drug treatment in patients with schizophrenia. Treatment with semaglutide, a glucagon-like peptide receptor agonist used to treat diabetes and approved in USA and Europe for treating obesity, could be a way to combat weight gain and achieve glycemic and also metabolic control for people with schizophrenia treated with antipsychoti drugs, however patients with serious mental illness is commonly excluded from phase 3 studies.MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2021-004452-42-NO
- Lead Sponsor
- Helse Bergen HF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 140
1. 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.
2. Men or woman aged between 18 and 70 years, both years included, at the time of signing informed consent.
3. 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.
4. 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.
5.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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1. 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.
2. Thyreoid stimulating hormone (TSH) within the normal range-Haukeland university hospital: 11-19 years: 0,51-4,30 mIU/L, >20 years: 0,40-4,50 mIU/L.
3. Medical or surgical treatment to reduce weight last 6 months before screening, or planned surgical treatment to reduce weight.
4. 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 6 months after the stop of study medication.
g. Breastfeeding.
h. Disorders, unwillingness or inability which in the investigator’s opinion might jeopardize the subject’s safety or compliance with the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method