Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
This research is an extension of a previous study and is looking at a new medicine called Maridebart Cafraglutide. It's for adults aged 18 to 99 who have both obesity and type 2 diabetes. The main goal is to understand how effective and safe this medicine is over a longer period. Participants will have already been part of a previous study (Study 20210184) and will continue to receive either the study medicine or a placebo (a dummy treatment). The study wants to find out if this medicine can help manage these conditions safely for the long term. This helps researchers gather more important information before the medicine could potentially be available more widely.
At a glance
What is this study about?
This clinical trial, called MARITIME-2-EXTENSION, is designed to continue looking at a new medicine called Maridebart Cafraglutide. It's for people who have both obesity (which means having a very high amount of body fat) and type 2 diabetes (a common condition where your body can't properly use sugar for energy). The main purpose of this study is to see how well this medicine works over a long time and to make sure it's safe for people to take.
This particular study is an 'extension' of an earlier trial. This means that people taking part will have already completed the first part of the research. By extending the study, scientists can gather more information about the medicine's long-term effects. This is really important because some benefits or side effects might only become clear after someone has been taking a medicine for a while.
The information gathered from studies like this helps doctors and researchers understand new treatments better. It's a key step in developing new medicines that could help people manage their health conditions more effectively in the future. The trial compares the new medicine with a 'placebo', which is a dummy treatment that looks just like the real medicine but contains no active drug.
Key takeaways
- This study is testing a new medicine for obesity and type 2 diabetes.
- It's an extension of a previous study to look at long-term effects.
- Participants will receive either the study medicine or a placebo.
- Safety and how well the medicine works over time are key goals.
- Strict rules apply for joining, including being in the earlier study and health checks.
- Your health will be closely monitored by the study team.
Who may be eligible?
To take part in this extended study, you must have already been in the first part of the trial (called Study 20210184) and completed your final visit at 72 weeks. You also must not have stopped taking the study medicine in the earlier trial. Most importantly, you need to be willing to follow all the study rules, including using specific birth control methods if you could become pregnant, for a certain period during and after the study.
There are also some reasons why you wouldn't be able to join. For instance, if you're planning to have surgery or a special procedure for obesity during the study, or if your body mass index (BMI) is very low (under 18.5). You also couldn't take part if you've had certain eye conditions, specific types of cancer that weren't fully treated, or if you've been diagnosed with a rare genetic condition called multiple endocrine neoplasia syndrome type 2, or have a close family member who had a specific type of thyroid cancer.
The research team also needs to make sure you're well enough to take part and can complete all the required visits and assessments. They'll also check your mental health, specifically for any signs of severe low mood or thoughts of self-harm, which would prevent you from joining for your safety.
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.
- Did I complete the first part of Study 20210184 (the parent study)?
- Did I finish my 72-week visit in the first study?
- Did I avoid stopping the study medicine early in the first study?
- Am I able to use specific birth control methods during and after the study?
- Do I have a BMI above 18.5?
- Do I feel well enough to attend all study visits and follow the rules?
What does participation involve?
If you join this study, you'll continue to receive either Maridebart Cafraglutide or a placebo, just like in the first part of the trial. This will involve regular visits to the clinic where the study team will carry out various checks. These checks might include blood tests, measuring your weight, blood pressure, and asking you questions about how you're feeling and any changes you've noticed.
You'll need to use specific birth control methods for the duration of the study and for 16 weeks after your last dose of the study medicine. It's important to attend all scheduled appointments so the researchers can keep track of your health and how the medicine is affecting you. The total length of your participation will depend on the study design, but it is an extension of a long-term trial, meaning it will likely continue for a significant period beyond the initial 72 weeks.
Potential risks and benefits
Locations (45)
- Gilbert Center for Family MedicineVerified postcodeGilbert, United States· Recruiting
- San Fernando Valley Health InstituteVerified postcodeCanoga Park, United States· Recruiting
- Core Healthcare GroupVerified postcodeCerritos, United States· Recruiting
- Velocity Clinical Research Chula VistaVerified postcodeLa Mesa, United States· Recruiting
- Paradigm Clinical ResearchVerified postcodeModesto, United States· Recruiting
- Empire Clinical ResearchVerified postcodePomona, United States· Recruiting
- San Marcus Research Clinic IncVerified postcodeMiami, United States· Recruiting
- Optimus U CorporationVerified postcodeMiami, United States· Recruiting
- Indago Research and Health CenterVerified postcodeMiami Lakes, United States· Recruiting
- Florida Institute for Clinical ResearchVerified postcodeOrlando, United States· Recruiting
- Encore Medical Research of Weston LLCVerified postcodeWeston, United States· Recruiting
- Conquest Research - Winter ParkVerified postcodeWinter Park, United States· Recruiting
Common questions
What is Maridebart Cafraglutide?
It's the name of the new medicine being tested in this research study for people with obesity and type 2 diabetes.
What does 'extension trial' mean?
It means this study is continuing to follow people who were already in an earlier part of the research, to see the effects of the medicine over an even longer time.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real medicine but doesn't contain any active drug. It helps researchers compare the effects of the new medicine.
Will I know if I'm getting the real medicine or the placebo?
No, in this type of study (called 'blinded'), neither you nor the study team will know who is getting which, until the study is over. This ensures the results are fair.
Can I leave the study at any time?
Yes, absolutely. Taking part is voluntary, and you can decide to stop participating at any point, and it won't affect your regular medical care.
How to find out more
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Always speak to your GP or specialist before deciding to take part in a study.
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