Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Does the glucagon-like peptide-1 receptor agonist semaglutide prevent deterioration of metabolic state in prediabetic or diabetic patients with schizophrenia treated with the antipsychotic compounds clozapine or olanzapine?

This research study is investigating a medicine called semaglutide, well-known as Ozempic, for people who have schizophrenia and are currently taking antipsychotic medicines such as clozapine or olanzapine. These particular antipsychotics can sometimes lead to problems with blood sugar and weight gain. The main aim of this study is to see if semaglutide can help prevent or improve these metabolic issues, like pre-diabetes or diabetes. Researchers will primarily measure changes in blood sugar levels (HbA1c). They will also look at other health markers like weight, waist size, blood pressure, and general well-being. This is an early-stage study (Phase II) to explore if this treatment is promising.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Psykiatrisk Center Kobenhavn

Enrolment target

104

Start

04 Nov 2024

Schizophrenia

What is this study about?

You're reading about a research study that's looking into a medicine called semaglutide. You might know it by its brand name, Ozempic. This study is for people who have schizophrenia and are currently being treated with specific medicines for their condition, namely clozapine or olanzapine. Sometimes, these particular antipsychotic medications can lead to side effects like weight gain and changes in how your body handles sugar, which can increase the risk of developing pre-diabetes or diabetes.

The main goal of this study is to find out if semaglutide can help prevent or slow down these metabolic problems in people taking clozapine or olanzapine. Researchers want to see if it can keep blood sugar levels more stable. They will primarily check this by looking at a long-term blood sugar marker called HbA1c, which gives an average of your blood sugar over the past few months.

Beyond blood sugar, the study will also look at many other aspects of your health. This includes changes in body weight, waist and hip measurements, blood pressure, and how well your body uses insulin. Researchers will also check other health indicators like liver function, bone health, and even your mood and overall quality of life. This is an exploratory study, meaning it's an early step to see if this treatment could be helpful in the future.

Key takeaways

The study investigates if semaglutide (Ozempic) can prevent blood sugar problems in schizophrenia patients on specific antipsychotics.
It's for adults with schizophrenia taking clozapine or olanzapine.
The main focus is on changes in long-term blood sugar (HbA1c) and other health markers.
Participants will receive either semaglutide or a placebo, neither knowing which one.
This is an early-stage study to explore the potential benefits of this treatment.
You can withdraw from the study at any time without affecting your usual care.

Who may be eligible?

This study is open to adults aged 18 and over, with no upper age limit. Both men and women can take part.

To be eligible, you must have a diagnosis of schizophrenia and be currently taking either clozapine or olanzapine for your treatment. The study is specifically designed for people who are at risk of, or already showing signs of, metabolic issues like pre-diabetes or diabetes, which can be a side effect of these antipsychotic medications.

There will be other detailed health checks to make sure the study is safe and suitable for you. These will likely include reviewing your medical history and current medications to ensure you meet all the study's requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of schizophrenia?
Are you currently taking clozapine or olanzapine for your schizophrenia?
Are you concerned about or have been told you have pre-diabetes or diabetes, or are you at risk of these conditions?
Are you able to attend regular clinic visits for assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would primarily receive either the study drug, semaglutide (Ozempic), or a placebo. A placebo is an inactive substance that looks just like the study drug, used to compare effects fairly. Neither you nor the study team will know if you are receiving the real drug or the placebo.

Participation will involve several visits to the clinic over time. At these visits, you will have various assessments. This includes regular blood tests to check your blood sugar levels (HbA1c) and other health markers, measurements of your weight, height, waist, and hip, and checks of your blood pressure and heart rate. You might also have scans for body composition and bone density.

Throughout the study, the research team will monitor your general health, any changes in your symptoms, and your quality of life. The total duration of your participation in the study, including follow-up visits, will be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a medication that could help manage your blood sugar and weight, or contributing to medical knowledge that could help others in the future. However, there are also potential risks, including side effects from the study medication or the placebo, or discomfort from blood tests and other procedures. You will be closely monitored for any health changes or side effects. It's very important to remember that participating is entirely your choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is semaglutide (Ozempic)?

Semaglutide, known as Ozempic, is a medicine often used to help manage blood sugar levels in people with type 2 diabetes and sometimes for weight management. In this study, we're looking at its potential to help prevent blood sugar problems in people with schizophrenia.

What is HbA1c?

HbA1c is a blood test that shows your average blood sugar levels over the past two to three months. It's a key indicator for diagnosing and monitoring pre-diabetes and diabetes.

What is a placebo?

A placebo is an inactive substance that looks exactly like the actual study medication. It's given to some participants to help researchers fairly compare the effects of the real medicine against not receiving it.

Why are they studying this for people with schizophrenia?

Some antipsychotic medicines used for schizophrenia, like clozapine and olanzapine, can sometimes cause weight gain and blood sugar problems. This study is exploring if semaglutide can help reduce these side effects.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study team will know whether you are receiving the actual study medication or the placebo until after the study is complete, to ensure unbiased results.