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Study on Semaglutide for Weight Control in Patients with Schizophrenia and High BMI Using Antipsychotics

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients who are using antipsychotic medications and are experiencing issues with their metabolic control. The study is investigating the effects of a treatment called semaglutide, which is administered as a solution for injection. Semaglutide is also known by the code name NNC0113-0217 and is being compared to a placebo. The purpose of the study is to explore how semaglutide can help manage body weight in patients with certain conditions.

Participants in this study will include individuals with schizophrenia spectrum disorders who have a Body Mass Index (BMI) of 30 or higher, or a BMI of 27 or higher if they also have prediabetes. Prediabetes is identified by specific levels of blood sugar and a measure called HbA1c. The study will last for 26 weeks, during which participants will receive either semaglutide or a placebo once a week. The main focus is to observe changes in body weight from the start to the end of the study.

Throughout the study, various health indicators will be monitored, including blood sugar levels, cholesterol, and other factors related to heart health. Additionally, the study will assess changes in cognitive function, quality of life, and other health outcomes. The goal is to understand the potential benefits of semaglutide for improving metabolic health in patients taking antipsychotic medications.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, informed consent is required. This means agreeing to participate after understanding the study's purpose and procedures.
Eligibility is confirmed based on criteria such as age, body mass index (BMI), and medical history related to schizophrenia-spectrum disorders and prediabetes.
Step 2
Initial assessments
Initial assessments include measuring body weight, fasting plasma glucose (FPG), and HbA1c levels. These tests help establish a baseline for the study.
Additional assessments may include evaluating cholesterol levels, insulin levels, and other health indicators.
Step 3
Medication administration
Participants receive either semaglutide or a placebo. Semaglutide is administered as a subcutaneous injection once a week.
The dosage of semaglutide is 2.4 mg per injection. The treatment continues for a duration of 26 weeks.
Step 4
Ongoing monitoring
Throughout the study, regular monitoring of health indicators such as body weight, blood glucose levels, and cholesterol is conducted.
Participants may also undergo assessments of cognitive function and quality of life using standardized questionnaires.
Step 5
Final assessments
At the end of the 26-week period, final assessments are conducted to measure changes in body weight and other health indicators.
The study aims to evaluate the effectiveness of semaglutide in managing metabolic conditions in patients using antipsychotic medications.

Who can join the trial?

6 criteria

Informed consent must be obtained before any trial-related activities. This means you agree to participate after understanding the study details.
You must be a man or woman aged between 18 and 70 years at the time of signing the informed consent.
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Your Body Mass Index (BMI) should be 30 kg/m² or higher, or 27 kg/m² or higher if you have prediabetes. Prediabetes is determined by either:
- Fasting plasma glucose (FPG) between 5.6 and 6.9 mmol/l
- or HbA1c between 39-47 mmol/mol
- You must have a diagnosis within the schizophrenia-spectrum according to the International Classification of Diseases version 10 (ICD-10): F 20, F 22, F 23, F 25, F 28, F 29.
- You must have been using antipsychotic (AP) drugs for at least 3 weeks before starting the study medication and have a treatment plan for further AP drug use for at least the next 6 months. Stopping AP drugs during the trial will not exclude you from continuing in the study.

Who cannot join the trial?

4 criteria

Patients who do not have a **BMI** (Body Mass Index) of 30 or above, or a BMI of 27 or above with **prediabetes**. Prediabetes is when blood sugar levels are higher than normal but not high enough to be considered diabetes.
Patients who do not have **schizophrenia spectrum disorders**. These are mental health conditions that affect how a person thinks, feels, and behaves.
Patients who do not have **fasting plasma glucose (FPG)** levels between 5.6 and 6.9 mmol/l. FPG is a test that measures blood sugar after not eating for at least 8 hours.
Patients who do not have **HbA1c** levels between 39-47 mmol/mol on two separate occasions at least 24 hours apart. HbA1c is a blood test that shows average blood sugar levels over the past 2 to 3 months.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Helse Bergen HF
Bergen, Norway
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Helse Stavanger HF
Stavanger, Norway
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Oslo Universitetssykehus HF
Oslo, Norway

Trial locations

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Investigated drugs

Semaglutide is a medication used in this clinical trial to help control metabolism in patients who are taking antipsychotic medications. It is given as an injection under the skin once a week. The main goal of using semaglutide in this study is to see if it can help reduce body weight in patients who have certain mental health conditions and are also dealing with weight issues or prediabetes. By helping to manage weight, semaglutide may improve overall health and reduce the risk of developing more serious health problems related to weight and blood sugar levels.

Semaglutide

What is already known about the treatment

Semaglutide – Semaglutide is administered as a subcutaneous injection, meaning it is given under the skin, typically once a week. It is currently being studied for its potential benefits in managing metabolic issues in patients who are taking antipsychotic medications. The main therapeutic use being explored is its ability to help control body weight in individuals with schizophrenia spectrum disorders who are also experiencing obesity or prediabetes. At the molecular level, semaglutide works by mimicking a natural hormone in the body that helps regulate blood sugar and appetite, which can lead to weight loss. It is classified pharmacologically as a GLP-1 receptor agonist, a type of medication that helps improve blood sugar control.

Investigated diseases

Schizophrenia Spectrum Disorders
Schizophrenia spectrum disorders are a group of mental health conditions characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions. These disorders often involve symptoms such as hallucinations, delusions, disorganized thinking, and impaired functioning. The progression can vary, with some individuals experiencing episodic symptoms while others may have a more chronic course. Over time, these disorders can lead to difficulties in maintaining relationships and employment. Cognitive impairments, such as problems with memory and attention, are also common. The severity and type of symptoms can change over time, often requiring ongoing management.
Obesity
Obesity is a condition characterized by excessive body fat accumulation that may impair health. It is typically defined by a body mass index (BMI) of 30 or higher. The condition develops gradually over time, often due to a combination of genetic, behavioral, and environmental factors. As obesity progresses, it can lead to increased risk of various health issues, including cardiovascular diseases and metabolic disorders. The accumulation of fat can affect the body's ability to regulate essential functions, such as blood sugar and cholesterol levels. Obesity can also impact physical mobility and overall quality of life.