A two-part, randomised, double-blind, placebo-controlled, parallel-group, 12week trial investigating the safety, tolerability, pharmacokinetics and efficacy of XEN-D0501 in obese participants
This clinical trial is looking at a potential new treatment for obesity called XEN-D0501. The study lasts 12 weeks and compares the new medicine against a dummy pill, known as a placebo. Researchers want to find out how safe the medicine is and what side effects it might cause. They also want to see whether it helps people reduce their weight, trim waist measurements, and improve health markers like blood sugar and cholesterol. Participants will be placed into groups by chance. Neither you nor the trial team will know who receives the real medicine or the placebo. Throughout the 12 weeks, the study team will closely monitor your health with regular health checks, blood tests, and heart traces. The findings will help doctors understand if this medicine could become a helpful treatment for managing weight in the future.
At a glance
What is this study about?
Obesity is a common health condition that can increase the risk of other long-term problems, such as type 2 diabetes and heart disease. While eating well and staying active are key parts of managing weight, scientists are also working to develop new medicines that can give extra support to people trying to improve their health.
This study focuses on an experimental medicine named XEN-D0501. The main purpose of the trial is to see if the medicine is safe to take and whether the human body tolerates it well over 12 weeks. Researchers also want to see how the body absorbs and breaks down the drug.
In addition to safety, the study looks at how well the medicine works for weight management. Researchers will measure changes in total body weight, body fat levels, and waist size. They will also look at whether the treatment improves blood sugar and blood fat levels, which are important markers for long-term health.
Because this is an early-stage study, it plays a vital part in testing new ideas. The results will help scientists decide whether XEN-D0501 could be a safe, effective option for people living with obesity in the years ahead.
Key takeaways
- Tests a new experimental medicine called XEN-D0501 for weight management.
- Compares the study drug against an inactive dummy pill (placebo) over 12 weeks.
- Aims to check safety, side effects, body weight changes, and blood sugar levels.
- Open to adults aged 18 and older who are living with obesity.
- Requires regular clinic visits for blood tests, body measurements, and heart checks.
- Participation is entirely voluntary and you can withdraw at any time.
Who may be eligible?
This study is open to adults aged 18 and over who are living with obesity. Men and women can both take part.
Because this is an early-stage clinical trial, the research team will need to ensure it is safe for you to join. You will have a thorough screening visit where doctors review your medical history and carry out standard health checks.
You may not be able to join if you have certain existing health conditions, are taking specific medicines, or are pregnant or breastfeeding. The study team will explain all the full criteria before you agree 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.
- I am aged 18 or older.
- I have been told by a doctor or health professional that I am living with obesity.
- I am able to attend regular clinic appointments over a 12-week period.
- I am willing to take either the study drug or a dummy pill each day.
- I am comfortable having routine blood tests and heart checks.
What does participation involve?
Taking part in this study lasts for about 12 weeks of treatment, plus some time before and after for check-ups. You will be randomly assigned to take either XEN-D0501 or a matching dummy pill (placebo) each day.
You will need to attend regular clinic visits throughout the 12 weeks. At these visits, the medical team will measure your weight, waist, and hip size. They will also track your blood pressure, temperature, and pulse, and perform simple heart rhythm checks (ECGs). You will give blood samples to see how your body handles the medicine and to monitor your cholesterol and blood sugar levels. After finishing the 12-week course, there will be follow-up contact to confirm you are doing well.
Potential risks and benefits
Locations (1)
- —UnverifiedSweden
Common questions
What is a placebo and why is it used?
A placebo is an inactive pill that looks and tastes identical to the real medicine. It helps researchers see if any changes or side effects are truly caused by the study drug or by other factors.
Can I choose whether I receive the real medicine?
No. A computer assigns participants to the real medicine or the placebo entirely by chance. Neither you nor the doctors will know which one you are taking during the trial.
Do I have to pay to take part in this trial?
No, you do not have to pay. The study treatment and all trial-related tests are provided free of charge, and studies often help cover reasonable travel expenses.
What happens if I experience side effects?
The medical team monitors you closely throughout the trial. You will be given contact numbers to report any unwanted symptoms, and the team will step in promptly to care for you.
Can I stop taking part if I change my mind?
Yes, you can leave the study at any point without giving a reason. Your standard medical treatment and relationship with your doctors will stay exactly the same.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.