This clinical trial is focused on studying the effects of a treatment called Maridebart Cafraglutide in adults who are either overweight or have obesity but do not have Type 2 Diabetes Mellitus. The main goal of the study is to see if Maridebart Cafraglutide can help reduce body weight more effectively than a placebo. Maridebart Cafraglutide is a solution for injection and is also known by its code name, AMG 133. It is a type of protein that combines a monoclonal antibody with a peptide, which is a small protein-like chain.
Participants in the study will receive either Maridebart Cafraglutide or a placebo and will be monitored over a period of 72 weeks. The study will track changes in body weight, waist circumference, and other health indicators such as blood pressure and fasting glucose levels. The aim is to observe the percentage change in body weight and other health improvements over this time.
The study is designed to help understand how effective and safe Maridebart Cafraglutide is for managing weight in people without Type 2 Diabetes Mellitus. By the end of the study, researchers hope to gather valuable information on how this treatment can aid in chronic weight management and improve the quality of life for those who are overweight or have obesity.
1joining 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 weight management.
2initial assessment
An initial assessment is conducted to record baseline measurements. This includes body weight, waist circumference, and other health indicators.
Participants are asked to maintain lifestyle logs and follow lifestyle advice provided by the study team.
3medication administration
Participants receive either the study medication, maridebart cafraglutide, or a placebo. The medication is administered as a solution for injection under the skin (subcutaneous use).
The frequency and dosage of the medication are determined by the study protocol and are administered regularly throughout the study duration.
4ongoing monitoring
Regular follow-up visits are scheduled to monitor progress. These visits include measurements of body weight, waist circumference, and other health indicators.
Participants complete questionnaires about their quality of life and physical function.
5final assessment
At the end of the study period, a final assessment is conducted. This includes measuring changes in body weight, waist circumference, and other health indicators.
The study aims to evaluate the percentage change in body weight and other health outcomes over a period of 72 weeks.
Who Can Join the Study?
The participant must have given their agreement to join the study by signing a consent form.
The participant must be at least 18 years old or older, depending on the legal age in their country.
The participant must have a Body Mass Index (BMI) of 30 or higher. BMI is a measure of body fat based on height and weight.
If the participant’s BMI is between 27 and 30, they must have at least one of the following health conditions related to weight:
Hypertension: High blood pressure, either treated or with a systolic blood pressure (SBP) of 130 or higher, or a diastolic blood pressure (DBP) of 80 or higher.
Dyslipidemia: Abnormal levels of fats in the blood, either treated or with:
Low-density lipoprotein (LDL) of 160 or higher.
Triglycerides of 150 or higher.
High-density lipoprotein (HDL) less than 40 for males or less than 50 for females.
Obstructive sleep apnea: A condition where breathing stops and starts during sleep.
Cardiovascular disease: Heart-related conditions, such as ischemic heart disease or heart failure classified as New York Heart Association (NYHA) Class I, II, or III.
Metabolic dysfunction-associated steatotic liver disease: A liver condition related to metabolism issues.
The participant must have tried at least once to lose weight through diet and exercise without success.
The participant must be considered by the study investigator to be motivated and willing to follow the study procedures, which include following lifestyle advice, keeping a lifestyle log, and attending all required study visits and completing questionnaires.
Who Cannot Join the Study?
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means groups that might need special protection or care.
Patients who have medical conditions other than Chronic Weight Management that might interfere with the study.
Patients who are not able to follow the study procedures or instructions.
Patients who are currently participating in another clinical trial.
Patients who have a history of allergic reactions to the study medication or similar medications.
Patients who are pregnant or breastfeeding.
Patients with certain medical conditions that the study doctors believe would make it unsafe for them to participate.
Maridebart Cafraglutide is a medication being studied for its potential to help people who are overweight or have obesity lose weight. It is not intended for people with type 2 diabetes. The main goal of this medication in the trial is to see if it can help reduce body weight more effectively than a placebo. Participants in the trial will receive this medication to evaluate its safety, how well it works, and how well people can tolerate it. The study aims to show that this medication can lead to a greater percentage of weight loss compared to not taking the active medication.
Obesity – Obesity is a chronic condition characterized by an excessive accumulation of body fat. It develops when there is an imbalance between calories consumed and calories expended, leading to weight gain. Over time, this condition can result in increased body mass index (BMI) and changes in body shape, particularly around the waist. As obesity progresses, it can affect physical mobility and lead to metabolic changes, such as increased blood pressure and altered glucose levels. The condition can also impact quality of life, affecting physical function and overall well-being. Obesity is often associated with other health issues, such as elevated triglycerides and changes in blood sugar levels.
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