Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
This research study is investigating a new medication, Maridebart Cafraglutide, for adults who are overweight or have obesity. It aims to see if this medicine can help people lose more weight compared to a placebo, which is a treatment without any active drug. Participants will be aged 18 or older and will not have Type 2 diabetes. The study will involve giving some people the new medicine and others the placebo, then carefully monitoring changes in their body weight. The main goal is to understand if Maridebart Cafraglutide is a better option for weight loss than current common approaches. This type of study, called a Phase 3 trial, is a crucial step before a new medicine can be widely approved.
At a glance
What is this study about?
This study is called a 'Phase 3' trial, which means it's one of the final steps in testing a new medicine before it might become available to everyone. It's looking at a new drug called Maridebart Cafraglutide. The main aim is to find out if this medicine is better at helping people lose weight than a 'placebo' – that's a dummy treatment that looks just like the real medicine but contains no active ingredients. This helps researchers understand the true effect of the new drug.
The study involves adults who are overweight or have obesity but do not have Type 2 diabetes. Participants will be randomly given either the new medicine or the placebo. Researchers will then carefully track how much their body weight changes over time. They want to see if the group taking Maridebart Cafraglutide loses significantly more weight.
Finding new ways to manage weight is important because being overweight or having obesity can lead to other health problems like high blood pressure or sleep apnoea. This research is trying to see if Maridebart Cafraglutide could be a safe and effective new tool to help people achieve healthier weights. Your health and safety will be closely monitored throughout the study.
Key takeaways
- This study is testing a new medicine for weight loss in adults who are overweight or have obesity.
- It aims to see if Maridebart Cafraglutide works better than a dummy treatment (placebo).
- Participants will not have Type 2 diabetes.
- Being overweight or having obesity and having tried to lose weight before are key requirements.
- The study is a Phase 3 trial, a crucial step before new medicines can be approved.
- Your health and safety would be closely monitored throughout.
Who may be eligible?
To join this study, you need to be an adult aged 18 or older. You should be considered to have obesity (a Body Mass Index, or BMI, of 30 or more), or be overweight (a BMI between 27 and 30) AND have at least one other health condition linked to weight, such as high blood pressure, high cholesterol, sleep apnoea, heart disease, or certain liver conditions.
You also need to have tried to lose weight through diet and exercise at least once before, without success. It's important that you haven't been diagnosed with Type 1 or Type 2 diabetes, or a weight problem caused by other hormone issues.
There are also some reasons you wouldn't be able to join. For example, if your weight has changed a lot (more than 5 kg) in the last 3 months, or if you or a close family member has a history of a rare thyroid cancer or certain genetic conditions. Also, if you've had certain heart problems, a recent history of pancreas problems, or a severe, unstable mental health condition within the last two years, including a history of attempting suicide, you wouldn't be able to take part.
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 obesity (BMI 30+) or are you overweight (BMI 27-30) AND have other weight-related health issues like high blood pressure or sleep apnoea?
- Have you tried to lose weight with diet and exercise before, but it didn't work?
- Do you NOT have Type 1 or Type 2 diabetes?
- Have you NOT had a big weight change (over 5kg) in the last 3 months?
- Do you NOT have a family or personal history of certain rare thyroid cancers or specific endocrine conditions?
What does participation involve?
If you decide to take part, you'll be given either the new study medicine, Maridebart Cafraglutide, or a placebo (a dummy treatment). You won't know which one you're receiving, and neither will the study staff – this is called 'blinding' and helps make the results fair. You'll need to attend regular appointments at the study clinic for check-ups, where the team will take measurements, blood samples, and ask about your health and any side effects.
The exact number of visits, how often they are, and the total length of your participation will be explained in detail by the study team. Usually, these types of studies involve several months or even a year or two of follow-up. You'll receive all necessary study medication and will be closely monitored by medical professionals throughout your time in the study.
Potential risks and benefits
Locations (243)
- Pinnacle Research Group LLCVerified postcodeAnniston, United States
- Alliance For Multispecialty Research - DaphneVerified postcodeDaphne, United States
- Alliance for Multispecialty Research MobileVerified postcodeMobile, United States
- Avacare Foothills Research CenterVerified postcodePhoenix, United States
- Ark Clinical Research- TustinVerified postcodeFountain Valley, United States
- Long Beach Clinical Trials Services IncVerified postcodeLong Beach, United States
- Ark Clinical Research- Long BeachVerified postcodeLong Beach, United States
- Catalina Research InstituteVerified postcodeMontclair, United States
- Artemis Institute for Clinical ResearchVerified postcodeRiverside, United States
- Artemis Institute for Clinical ResearchVerified postcodeSan Diego, United States
- Apex Clinical ResearchVerified postcodeSan Diego, United States
- Southern California Clinical ResearchVerified postcodeSanta Ana, United States
Common questions
What is a placebo?
A placebo is a 'dummy' treatment that looks exactly like the real medicine but doesn't contain any active drug. It helps researchers fairly compare the new medicine's effects.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor the study team will know which treatment you are receiving. This is a common practice in research called 'blinding' to ensure the results are unbiased.
What does 'Phase 3' mean for a study?
Phase 3 is one of the final stages of testing a new medicine. It means the drug has already been tested in smaller groups and is now being studied in a larger group of people to confirm its effectiveness and safety.
What kind of health checks will I have during the study?
You will have regular medical check-ups, which may include body measurements, blood tests, and discussions about your general health and any possible side effects you might experience.
Can I leave the study at any time?
Yes, absolutely. You are free to withdraw from the study at any time, for any reason, without needing to explain why, and it will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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