Psykiatrisk Center Kobenhavn
Verified
Copenhagen, Denmark
Not recruiting
Study on Semaglutide for Preventing Metabolic Issues in Prediabetic or Diabetic Patients with Schizophrenia on Clozapine or Olanzapine
Verified siteRegistered drug
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the effects of a medication called semaglutide on patients with schizophrenia who also have prediabetes or type 2 diabetes. Schizophrenia is a mental health condition that affects how a person thinks, feels, and behaves. Prediabetes and type 2 diabetes are conditions where blood sugar levels are higher than normal, which can lead to various health issues. The study will compare the effects of semaglutide, which is given as a solution for injection, with a placebo. The purpose of the study is to see if semaglutide can help prevent the worsening of the metabolic state, which refers to the body's ability to process and use energy, in these patients.
Participants in the study will receive either semaglutide or a placebo once a week for a period of 26 weeks. The study will monitor changes in various health indicators, including blood sugar levels, body weight, and other factors related to metabolism. The main focus will be on changes in glycated hemoglobin A1c (HbA1c), which is a measure of average blood sugar levels over time. Other aspects such as body weight, blood pressure, and quality of life will also be observed.
The study is designed for adults aged 18 to 65 who have started treatment with antipsychotic medications like clozapine or olanzapine, which are used to manage schizophrenia. These medications can sometimes affect metabolic health, so the study aims to explore whether semaglutide can offer benefits in this area. The trial will help researchers understand the long-term effects of semaglutide on metabolic health in this specific group of patients.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
11 criteria
- Must be between 18 and 65 years old.
- Must have been diagnosed with schizophrenia.
- Must have started daily treatment with either clozapine or olanzapine within the last 60 months. These are medications used to treat schizophrenia.
- Must have been diagnosed with either prediabetes or type 2 diabetes. These are conditions related to high blood sugar levels.
- For prediabetes, blood tests must show one of the following results, confirmed on a different day:
- HbA1c level between 35-47 mmol/mol. HbA1c is a test that shows average blood sugar levels over the past 2-3 months.
- Fasting plasma glucose (FPG) between 5.6-6.9 mM. This is a blood sugar test taken after not eating for at least 8 hours.
- Blood sugar level between 7.8-11.0 mM two hours after drinking a sugary drink during a test called OGTT (Oral Glucose Tolerance Test).
- For type 2 diabetes, blood tests must show one of the following results, confirmed on a different day:
- HbA1c level between 48-57 mmol/mol.
- Fasting plasma glucose (FPG) between 6.9-9.9 mM.
- Blood sugar level greater than 11 mM two hours after drinking a sugary drink during the OGTT.
- Both males and females can participate.
Who cannot join the trial?
4 criteria
- Patients who are not between the ages of 18 and 65 years.
- Patients who do not have a diagnosis of schizophrenia.
- Patients who have not started treatment with the medications clozapine or olanzapine. These are specific medications used to treat schizophrenia.
- Patients who do not have prediabetes or diabetes. Prediabetes means having higher than normal blood sugar levels, but not high enough to be classified as diabetes.
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
Tell us about your condition – we search every trial in Europe and connect you with the right site.
We usually reply within a few days
Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Trial locations
Where you can join this trial
Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.
Not recruitingNot finding your country?
Not sure what to do next?
Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.
Investigated drugs
Semaglutide
is a medication used in this study to see if it can help prevent worsening of the metabolic state in patients who have prediabetes or diabetes. It is given once a week and works by mimicking a hormone in the body that helps control blood sugar levels. The study is looking at its effects over a period of 26 weeks.
Clozapine
is an antipsychotic medication used to treat schizophrenia. It helps manage symptoms such as hallucinations, delusions, and thought disorders. In this study, patients who are starting treatment with clozapine are being observed to see how it affects their metabolic state, especially if they have prediabetes or diabetes.
Olanzapine
is another antipsychotic medication used to treat schizophrenia. Like clozapine, it helps control symptoms of the disorder. The study is examining its impact on the metabolic health of patients with prediabetes or diabetes who are beginning treatment with olanzapine.
What is already known about the treatment
Semaglutide – Semaglutide is administered as a once-weekly injection under the skin. It is currently being studied for its potential to prevent worsening of metabolic conditions in patients with schizophrenia who are also prediabetic or diabetic. The main therapeutic indication being explored is its effect on metabolic health in these patients. At the molecular level, semaglutide works by mimicking the action of a natural hormone called GLP-1, which helps regulate blood sugar levels. It is classified as a GLP-1 receptor agonist, a type of medication commonly used to manage blood sugar in diabetes.
Investigated diseases
Schizophrenia – Schizophrenia is a chronic mental health disorder that affects how a person thinks, feels, and behaves. Individuals with schizophrenia may experience symptoms such as hallucinations, delusions, and disorganized thinking. These symptoms can lead to difficulties in distinguishing between what is real and what is not. The disorder often begins in late adolescence or early adulthood and can vary in severity. Over time, it may lead to social withdrawal and challenges in daily functioning. The progression of schizophrenia can be influenced by various factors, including environmental and genetic components.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518746-24-00Estimated enrolment104 patientsSponsorPsykiatrisk Center Kobenhavn
sourced from the EU Clinical Trials Register and site verification
Want to learn more about this trial or check if you can participate?