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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).
EU CTIS ID: 2023-506109-20-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 29.
- 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.
You likely can't join if
- 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 3 months before screening. e. Treatment with insulin last 3 months before screening. f. Treatment with metformin last 4 weeks before drug initiation.
- Clearly disturbed thyroidal function as in an untreated hypo- or hyperthyroidism.
- 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 anorexia nervosa defined: a specialist diagnosed anorexia nervosa of ICD-10 F50.0 or F50.1 last ten years before randomization. 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. See exception clause in section 10.4.2.1. 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.