A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of Co-administration of AZD9550 and AZD6234 in Participants Living With Obesity or Overweight with Comorbidity
This research study is investigating a new combination of two potential medications, AZD9550 and AZD6234, for people who are struggling with obesity or are overweight and have other related health conditions. The main goal is to find out if these new medicines can help people lose weight, specifically focusing on how much weight is lost over 36 weeks. Researchers will also be checking to make sure the medicines are safe and well-tolerated. Some participants will receive the active medicines, while others will receive a placebo (dummy treatment) to compare the results fairly. The study is open to adults aged 18 and over, of any gender. It's a 'Phase II' study, meaning it's still in the earlier stages of testing to see if the treatment works and is safe.
At a glance
What is this study about?
This study is looking into a new way to help people who are overweight or have obesity, especially if they also have other health problems linked to their weight. The researchers are testing a combination of two potential new medicines, called AZD9550 and AZD6234. They want to see if taking these two medicines together can lead to meaningful weight loss and help improve overall health.
The main things the researchers will be watching are changes in body weight over a period of 36 weeks (about 8 months). They'll measure how much weight people lose and how many people lose at least 5% of their starting body weight. They'll also be carefully checking for any side effects and making sure the medicines are safe to use. This kind of study helps us understand if new treatments could be helpful and safe for people in the future.
It's important to remember that this is a 'Phase II' study. This means it's still quite early in the testing process for these medicines. The purpose is to explore how well the treatment works and its safety, rather than being a final step before making the medicines widely available.
Key takeaways
- This study evaluates new medicines (AZD9550 and AZD6234) for weight loss.
- It's for adults with obesity or overweight, plus other health conditions.
- The main goal is to see how much weight is lost over 36 weeks.
- Researchers will also carefully check for safety and side effects.
- Some participants will receive a placebo (dummy medicine).
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
The researchers are specifically looking for people who are living with obesity or are overweight and also have other health conditions that are often linked to weight. These 'other health conditions' aren't fully listed here, but a doctor involved in the study would be able to tell you more if you might fit this description.
There will also be other specific health requirements or conditions that might mean you can't take part, even if you meet the age and weight criteria. These details would be discussed with you by the study team during a screening process.
- Are you 18 years old or older?
- Do you identify as male or female?
- Do you have obesity or are you overweight?
- Do you also have other health problems linked to your weight?
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 will likely be asked to attend several appointments at a clinic over 36 weeks (about 8 months). During these visits, the study team will carry out health checks, take measurements like your weight, and ask about your general health and any side effects you might be having.
You will be given the study medicines, which could be the active combination of AZD9550 and AZD6234, or it could be a placebo (a dummy medicine that looks like the real thing but has no active ingredients). This is done to fairly compare the effects of the new medicines. You'll also be given other supportive medicines like Cyclizine or Ondansetron if you experience nausea.
The specific details of what each visit involves, including blood tests or other assessments, will be fully explained to you before you agree to join. After the 36 weeks of treatment, there might also be some follow-up appointments to check on your health.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What are AZD9550 and AZD6234?
These are names for new medicines that are being tested to see if they can help people lose weight, particularly those with obesity and other related health issues.
What does 'placebo-controlled' mean?
It means some people in the study will receive the new medicines, while others will receive a 'dummy' pill that looks the same but has no active ingredients. This helps researchers fairly compare how well the new medicines work.
How long will the study last for each person?
The main treatment period for the study is 36 weeks, which is about 8 months. There may be follow-up appointments after this.
Is this medicine available to the public now?
No, this is a 'Phase II' study, meaning the medicines are still being tested in clinical trials and are not yet available for general use by patients.
What if I feel unwell during the study?
Your health and safety will be monitored very closely. You will be able to contact the study team if you feel unwell or have any concerns, and they will provide guidance and 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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