A Phase III Randomised, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants with Obesity or Overweight With at Least One Weight Related Comorbidity Without Type 2 Diabetes Mellitus
This Phase III clinical trial investigates whether a new study drug called AZD6234 can safely help people lose weight and improve their health. It is designed for adults who are overweight or living with obesity and also have at least one weight-related condition, such as high blood pressure or high cholesterol. Participants will receive either the study medicine or an inactive dummy treatment (called a placebo) for 68 weeks. Neither the participants nor the research doctors will know who gets which treatment during the study. Throughout the trial, doctors will regularly monitor body weight, waist measurements, heart health, and blood test results. The main goal is to find out how much weight people lose and whether the treatment is safe and well tolerated.
At a glance
What is this study about?
Living with excess weight can increase the chance of developing health problems like high blood pressure, heart disease, or joint pain. While diet and lifestyle changes are an essential part of managing weight, many people find it difficult to lose weight or keep it off. Researchers are looking for new medicines that can work alongside lifestyle support to help people manage their weight long term.
This study is testing an experimental medicine called AZD6234. It is a Phase III trial, which means earlier studies have already tested the drug in smaller numbers of people. Researchers now need to test it in a much larger group to confirm how well it works, see how much weight people can lose, and check for any side effects.
Over the course of 68 weeks (around 16 months), the trial will compare the new medicine with a placebo, which looks identical but contains no active drug. By comparing the two groups, doctors can clearly see whether any weight loss or health improvements are truly caused by the study medicine.
Key takeaways
- Tests a new medicine, AZD6234, to help with weight management.
- Open to adults who are overweight or living with obesity and have a related health condition.
- Participants must not have type 2 diabetes.
- Treatment lasts for 68 weeks with regular check-ups and health monitoring.
- Participation is entirely voluntary, and you can stop at any time.
Who may be eligible?
To be eligible, you must be 18 years of age or older and be living with obesity, or be overweight with at least one related health problem. These related conditions might include high blood pressure, high cholesterol, or sleep apnoea.
This trial is specifically for people who do not have type 2 diabetes. If you have been diagnosed with type 2 diabetes, you will not be able to join this study, as diabetes and its treatments can affect body weight and blood sugar measurements.
The study team will review your full medical history, current medicines, and general health to make sure it is safe for you 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 over.
- I am living with obesity or consider myself overweight.
- I have a weight-related health problem, such as high blood pressure or high cholesterol.
- I do not have type 2 diabetes.
- I am able to attend regular clinic appointments over a period of 68 weeks.
What does participation involve?
Taking part lasts for around 68 weeks of treatment, plus extra time for initial health screening and follow-up checks. If you join, a computer will randomly choose whether you receive the active study medicine or a dummy treatment (placebo). You will need to attend regular clinic visits so the team can monitor your health. These visits will involve routine checks such as weighing you, measuring your waist, taking your blood pressure, and performing blood tests and heart traces (ECGs). You may also have special body scans (DXA scans) to measure body fat, and you will be asked to fill in simple questionnaires about your general wellbeing.
Potential risks and benefits
Locations (6)
- —UnverifiedItaly
- —UnverifiedCzechia
- —UnverifiedGermany
- —UnverifiedBulgaria
- —UnverifiedFrance
- —UnverifiedPoland
Common questions
What is a placebo?
A placebo is a dummy treatment designed to look just like the real medicine, but it contains no active ingredients. It helps researchers prove whether the real medicine actually works.
Will I know if I am getting the real medicine or the placebo?
No. This is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment you are receiving until the trial has ended.
Do I have to pay to take part in this trial?
No. Clinical trials in the UK are free to join. The study medicine, tests, and medical visits are provided at no cost, and travel expenses are often reimbursed.
Why are people with type 2 diabetes excluded?
Type 2 diabetes and diabetes medicines can directly affect weight and blood sugar. Looking at people without diabetes helps researchers understand how the medicine works on its own.
Can I leave the study early if I change my mind?
Yes. You have the right to withdraw from the trial at any point, for any reason, without it affecting your standard medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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