Not recruiting

Study on the Effects of Maridebart Cafraglutide for Adults with Type 2 Diabetes

Fast replyInvestigational

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 Type 2 Diabetes Mellitus, a condition where the body struggles to regulate blood sugar levels effectively. The treatment being tested is called maridebart cafraglutide, also known by its code name AMG 133. This treatment is a solution for injection and is designed to help manage blood sugar levels in adults with this type of diabetes. The study will compare the effects of maridebart cafraglutide with a placebo to understand how well it works and how safe it is for patients.

The purpose of the study is to explore how different doses of maridebart cafraglutide affect blood sugar control. Participants will receive either the treatment or a placebo and will be monitored over a period of time to see how their blood sugar levels change. The study will also look at other health factors, such as body weight and cholesterol levels, to get a comprehensive view of the treatment's impact.

Throughout the study, participants will have regular check-ups to track their progress and any side effects they might experience. The goal is to gather information on the safety and effectiveness of maridebart cafraglutide, which could lead to better treatment options for people living with Type 2 Diabetes Mellitus.

The research process

The trial runs in 4 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, you will be randomly assigned to receive either the study medication, maridebart cafraglutide, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.
The medication is administered as a solution for injection under the skin, known as subcutaneous use.
Step 2
Medication administration
You will receive the medication or placebo at specified intervals. The exact dosage and frequency will be determined by the study team based on the dose-ranging nature of the trial.
The duration of the medication administration phase is planned to last for 24 weeks.
Step 3
Monitoring and assessments
Throughout the study, your health and response to the medication will be closely monitored. This includes regular check-ups and tests to measure changes in your blood sugar levels, body weight, and other health indicators.
You will be required to perform self-monitoring of blood glucose (SMBG) and maintain a subject diary to record your experiences and any side effects.
Step 4
End of study evaluations
At the end of the 24-week period, final assessments will be conducted to evaluate the effects of the medication on your health.
These assessments will include measuring changes in your hemoglobin A1c (HbA1c) levels, body weight, and other health parameters.

Who can join the trial?

7 criteria

The person must have given their agreement to participate in the study before any study activities or procedures begin.
The person must be at least 18 years old at the time of screening, or older if the legal age in their country is higher than 18.
The person must have a Body Mass Index (BMI) between 23 and 50. BMI is a measure of body fat based on height and weight.
The person must have been diagnosed with Type 2 Diabetes Mellitus (T2DM) at least 180 days before the screening. This diagnosis should be based on the World Health Organization (WHO) classification.
The person's HbA1c level, which is a measure of blood sugar control over the past 2-3 months, must be between 7.0% and 10.5% at the time of screening.
The person must have been taking a stable dose of metformin (a medication for diabetes) of at least 1000 mg per day, with or without an SGLT2-inhibitor (another type of diabetes medication), for at least 90 days before screening.
The person must be able and willing to follow the study requirements, including self-monitoring of blood glucose (SMBG) and keeping a diary of their activities related to the study.

Who cannot join the trial?

9 criteria

Patients with any other type of diabetes besides Type 2 Diabetes Mellitus cannot participate.
Patients who are under 18 years old or over 75 years old cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of severe allergic reactions to any of the study medications cannot participate.
Patients with significant heart disease or uncontrolled high blood pressure cannot participate.
Patients with severe kidney or liver disease cannot participate.
Patients who have participated in another clinical trial within the last 30 days cannot participate.
Patients with a history of drug or alcohol abuse within the past year cannot participate.
Patients who are unable to comply with the study procedures cannot participate.

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

Futuremeds Sp. z o.o.
Responsive
Wroclaw, Poland
Soedersjukhuset AB
Responsive
Stockholm, Sweden
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate
Responsive
Chieti, Italy

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not 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.

See the full process and FAQ

Investigated drugs

Maridebart Cafraglutide is a medication being studied for its potential to help control blood sugar levels in people with type 2 diabetes. This medication is designed to improve how the body manages glucose, which is important for people with diabetes who struggle to maintain healthy blood sugar levels. The trial aims to understand how different amounts of this medication affect glucose control, ensuring it is both safe and effective for patients.

Maridebart Cafraglutide

What is already known about the treatment

Maridebart Cafraglutide – Maridebart Cafraglutide is administered as an injection and is currently being studied in clinical trials for its effectiveness in managing Type 2 Diabetes Mellitus. This medication is in the experimental phase and is not yet widely available in medical practice. It is designed to help control blood sugar levels in adults with Type 2 Diabetes by mimicking the action of a natural hormone that stimulates insulin release. Maridebart Cafraglutide belongs to a class of drugs known as GLP-1 receptor agonists, which work by enhancing the body's natural ability to regulate blood sugar.

Investigated diseases

Type 2 Diabetes Mellitus – Type 2 Diabetes Mellitus is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body's cells do not respond properly to insulin, and a relative lack of insulin production. Over time, high blood sugar levels can lead to various complications affecting the heart, blood vessels, nerves, eyes, and kidneys. The disease often develops gradually and may initially present with symptoms such as increased thirst, frequent urination, and fatigue. As the condition progresses, individuals may experience more severe symptoms and complications. Management of blood sugar levels is crucial to prevent further progression and complications.