An Open-Label Study of Mibavademab (REGN4461), a Leptin Receptor Agonist, for the Treatment of Monogenic Obesity Due to Biallelic Loss of Function Variants of the LEP Gene
This research is testing a new medicine called mibavademab for a rare type of obesity caused by a specific genetic problem. This condition means the body doesn't produce enough leptin, a hormone that helps control hunger and body weight. The study wants to find out if mibavademab can help people with this genetic obesity manage their weight more effectively. Researchers will be checking changes in body mass index (BMI), body weight, and body fat over a year. They'll also look at how the medicine affects feelings of hunger and overall well-being, and monitor for any side effects. This is a crucial step to see if this new treatment could help those affected.
At a glance
What is this study about?
This study is investigating a new medicine called mibavademab, which is designed to help people who have a very specific type of obesity. This particular kind of obesity is genetic, meaning it's passed down in families, and it happens when there's a problem with a gene called LEP. This gene is responsible for making a hormone called leptin. Leptin is really important because it tells your brain when you've had enough to eat and helps control your body's energy balance. When this gene doesn't work properly, the body doesn't produce enough leptin, which can lead to severe hunger and weight gain from a very young age.
The medicine being tested, mibavademab, acts like leptin in the body. The goal of this study is to see if it can help people with this genetic condition manage their hunger and reduce their body weight. The researchers will be carefully measuring various aspects of participants' health, such as changes in their body mass index (BMI), total body weight, and body fat. They will also be looking at how the medicine affects feelings of hunger and how often people feel excessively hungry, as well as checking for any side effects.
This is a Phase III study, which means it's a larger study designed to confirm the effectiveness and safety of the medicine after earlier, smaller studies have shown promising results. The information gathered from this study will be very important in understanding whether mibavademab could become a new treatment option for people living with this specific genetic form of obesity.
Key takeaways
- Tests a new medicine (mibavademab) for a specific genetic type of obesity.
- Aims to see if the medicine helps reduce weight and manage hunger.
- Participation involves regular visits and health checks over 15 months.
- Open to adults aged 18 and over with confirmed genetic LEP-related obesity.
- This is a Phase III study, a crucial step for potential new treatments.
Who may be eligible?
This study is looking for adults aged 18 and over, of any gender. People who take part must have a specific type of genetic obesity. This means their obesity is caused by a known problem with both copies of the 'LEP' gene in their body.
More details about specific health conditions or medications that might prevent someone from joining will be discussed with the study team. It's important to have a doctor confirm that your obesity is due to this particular genetic cause before considering participation in the study.
- Are you 18 years old or older?
- Has a doctor confirmed that your obesity is due to a problem with your LEP gene?
- Are you able to attend regular clinic visits for about 15 months?
- Are you willing to have blood tests, body measurements, and special scans?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would receive the new medicine, mibavademab. You would have regular visits to the study clinic over a period of about 65 weeks (around 15 months). During these visits, the study team would take measurements like your height and weight, check your blood pressure, and take blood samples. They would also use a special scan called a DXA scan to look at your body fat. You'll be asked to fill out questionnaires about your hunger and how it affects your daily life. These regular checks help the researchers understand how the medicine is working and monitor your health carefully. The total length of your participation in the study would be approximately 65 weeks.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is 'monogenic obesity'?
Monogenic obesity is a rare type of severe obesity caused by a problem with just one specific gene, in this case, the LEP gene. It means the body doesn't produce enough of a hormone called leptin, which helps control hunger.
What is 'mibavademab'?
Mibavademab is the name of the new medicine being tested in this study. It's designed to act like the natural leptin hormone in the body, which is missing or not working properly in people with this type of genetic obesity.
What does 'Phase III study' mean?
A Phase III study is a later stage of research. It means the medicine has already been tested in smaller groups, and now researchers want to confirm its effectiveness and safety in a larger group of people before it can potentially be approved for wider use.
Will I know if I'm getting the actual medicine?
This study is 'open-label,' which means both you and the research team will know that you are receiving the active study medicine, mibavademab. There is no placebo group in this specific study.
How long will the study last for me?
If you take part, your involvement in the study will last for approximately 65 weeks, which is about 15 months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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