This clinical trial is focused on studying the effects of a treatment called maridebart cafraglutide on adults with Type 2 Diabetes Mellitus who are either overweight or have obesity. The treatment is administered as a solution for injection and is being compared to a placebo. The main goal of the study is to determine if maridebart cafraglutide can lead to a greater reduction in body weight compared to the placebo.
Participants in the study will receive either maridebart cafraglutide or a placebo over a period of 72 weeks. Throughout the study, changes in body weight, waist circumference, and other health markers such as blood pressure and blood sugar levels will be monitored. The study will also assess the impact of weight changes on the quality of life of the participants.
The study aims to provide valuable information on the effectiveness and safety of maridebart cafraglutide for managing weight in individuals with Type 2 Diabetes Mellitus. This research could potentially lead to new treatment options for those struggling with weight management in the context of diabetes.
1initial visit
Upon joining the study, the first step involves an initial visit. During this visit, a healthcare professional will explain the study procedures and answer any questions. Consent will be confirmed, ensuring understanding of the study’s purpose and requirements.
Basic health measurements will be taken, including weight, height, and waist circumference. Blood samples may be collected to assess health markers such as blood sugar levels and hemoglobin A1c, which is a measure of blood sugar control over time.
2randomization
Participants 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 study drug.
This process is double-blind, meaning neither the participant nor the study team will know which treatment is being received, to ensure unbiased results.
3medication administration
The study medication or placebo will be administered as a solution for injection under the skin, known as subcutaneous use. The frequency and dosage will be determined by the study protocol and communicated during the initial visit.
Participants will be instructed on how to self-administer the injections or will receive them during study visits, depending on the study’s design.
4regular follow-up visits
Regular follow-up visits will be scheduled throughout the study duration, which is approximately 72 weeks. These visits are essential for monitoring health status, medication effects, and any side effects.
During these visits, health measurements will be repeated, and participants may be asked to complete questionnaires about their health and quality of life.
5self-monitoring
Participants will be required to perform self-monitoring of blood glucose as per the study protocol. This involves checking blood sugar levels at home using a glucose meter.
A study log or diary will be maintained to record daily health information, medication administration, and any symptoms or side effects experienced.
6final assessment
At the end of the study period, a final assessment will be conducted. This includes a comprehensive evaluation of health changes, such as weight loss, waist circumference, and blood sugar control.
The results will contribute to understanding the efficacy and safety of maridebart cafraglutide in managing weight and diabetes.
Who Can Join the Study?
The participant must have given their agreement to join the study after understanding what it involves.
The participant must be at least 18 years old, or older if the legal age in their country is higher.
The participant must have a Body Mass Index (BMI) of 27 or higher. BMI is a measure that uses height and weight to estimate body fat.
The participant must have tried to lose weight at least once by diet and exercise but was not successful.
The participant must have been diagnosed with Type 2 Diabetes Mellitus (T2DM) at least 180 days before joining the study. This is based on guidelines from the World Health Organization (WHO).
The participant’s Hemoglobin A1c level, which is a measure of blood sugar levels over the past 2-3 months, must be between 7.0% and 10.0% at the time of joining the study.
The participant must be managing their Type 2 Diabetes Mellitus (T2DM) with diet and exercise alone, or with a stable treatment of up to 3 oral medications that lower blood sugar, for at least 90 days before joining the study. However, they should not be using certain medications called DPP-4 inhibitors or GLP-1RAs.
The participant must be considered by the study doctor to be well-motivated and willing to follow the study procedures, which include following lifestyle advice, keeping a study diary, attending required study visits, completing questionnaires, and checking their blood sugar levels as instructed.
Who Cannot Join the Study?
Patients with a history of severe heart disease cannot participate.
Individuals with uncontrolled high blood pressure are excluded. High blood pressure means the force of the blood against your artery walls is too high.
People with a history of certain types of cancer are not eligible.
Participants who have had surgery for weight loss in the past year cannot join.
Those with a history of drug or alcohol abuse in the past year are excluded.
Women who are pregnant or breastfeeding cannot participate.
Individuals currently participating in another clinical trial are not eligible.
Patients with a known allergy to the study medication or similar drugs cannot join.
People with certain mental health conditions that are not well controlled are excluded.
Individuals with severe liver or kidney disease cannot participate.
Maridebart Cafraglutide is a medication being studied for its potential to help people with type 2 diabetes who are also overweight or have obesity. This medication is designed to help reduce body weight. It works by mimicking a hormone in the body that helps regulate appetite and food intake, which may lead to weight loss. The goal of using this medication in the trial is to see if it can effectively help participants lose weight compared to those who do not receive the medication. The study aims to evaluate how safe and well-tolerated this medication is for the participants.
Obesity – Obesity is a chronic condition characterized by an excessive accumulation of body fat. It develops when there is an imbalance between calorie intake and energy expenditure, leading to weight gain. Over time, this condition can result in increased body mass index (BMI) and changes in body composition. As obesity progresses, it can affect various bodily functions and contribute to the development of other health issues. The condition often leads to increased waist circumference and can impact metabolic processes. Obesity is a significant risk factor for various diseases, including type 2 diabetes and cardiovascular disorders.
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