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AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Phase III Randomized, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants with Type 2 Diabetes Mellitus and Obesity or Overweight

This clinical trial is looking at a new medicine called AZD6234 for adults who have both type 2 diabetes and are overweight or living with obesity. Carrying excess weight can make diabetes harder to manage and increase the risk of other health issues, such as heart disease. Researchers want to find out whether AZD6234 can help people lose weight safely and keep it off. They will also measure how well it lowers blood sugar levels (HbA1c), reduces waist size, and improves blood pressure. Participants will take either the study drug or an inactive dummy treatment (placebo) for 68 weeks. Neither the participants nor the research doctors will know who is receiving which treatment. Throughout the trial, doctors will closely monitor everyone's health and safety through regular check-ups, blood tests, and scans.

At a glance

Status
Authorised
Phase
Therapeutic confirmatory (Phase III)
Sponsor
AstraZeneca AB
Enrolment target
420
Start
05 Oct 2026

What is this study about?

Type 2 diabetes is a common condition that causes the level of sugar in the blood to become too high. For many people, living with overweight or obesity makes it harder to keep blood sugar under control. It can also raise the chance of developing high blood pressure, high cholesterol, and heart problems. Finding new treatments that tackle both weight and blood sugar together is an important area of medical research.

This clinical trial is testing an experimental medicine known as AZD6234. The main goal is to find out if AZD6234 helps adults with type 2 diabetes lose a meaningful amount of weight over 68 weeks. Researchers will also look at how the drug affects overall health markers, including average blood sugar (HbA1c), waist measurements, blood pressure, and blood fats.

Because this is a Phase III study, it is one of the final stages of testing before a new medicine can be approved for wider use by the public. The results will help doctors understand whether the treatment works well and is safe to use as a long-term option for people managing both type 2 diabetes and weight.

Key takeaways

  • Tests a new medicine (AZD6234) for weight loss in adults with type 2 diabetes.
  • Compares the study drug against an inactive dummy treatment (placebo).
  • Treatment lasts for 68 weeks with regular clinic appointments and health checks.
  • Aims to check safety, weight loss, and improvements in blood sugar and blood pressure.
  • Participation is entirely voluntary, and you can withdraw at any time.

Who may be eligible?

This study is open to adults aged 18 and older of any sex who have been diagnosed with type 2 diabetes and are also carrying excess weight (overweight or obese).

To be considered, participants must meet specific health criteria set by the study team. These rules ensure that taking part is as safe as possible and that the results are reliable.

You may not be eligible if you have certain other medical conditions, severe diabetes complications, or if you take particular medicines that could interfere with the study. The study doctors will review your complete medical history and run routine health checks to confirm if the trial is right for you.

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.

  1. I am aged 18 or older.
  2. I have been diagnosed with type 2 diabetes.
  3. A doctor has told me that I am overweight or living with obesity.
  4. I am able and willing to attend regular clinic check-ups over 68 weeks.
  5. I am willing to take either the study medicine or a dummy treatment (placebo).
Answer every question to see your result.

What does participation involve?

Taking part in this study lasts for just over 68 weeks (around 16 months). You will be randomly placed into one of two groups: one group will receive the study medicine AZD6234, and the other will receive a placebo, which looks identical but has no active ingredients. A computer chooses your group by chance, and neither you nor your study doctor will know which one you are taking.

Throughout the study, you will have regular clinic visits so the team can monitor your health. These visits will include checks such as blood pressure and pulse readings, blood and urine tests, and heart tracings (ECGs). You may also have body scans, known as DXA scans, to measure body fat and muscle, and you will be asked to fill in simple questionnaires about your general well-being.

Potential risks and benefits

You might experience health benefits such as weight loss and better blood sugar control, but this cannot be guaranteed. You will also receive regular, detailed health check-ups from a specialist team. However, as with any medicine, there may be side effects, some of which might not yet be known. You could also be given the placebo rather than the active medicine. Taking part is completely voluntary, and you can choose to leave the study at any time without giving a reason and without your normal NHS care being affected.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    Spain
  • —
    Unverified
    Poland
  • —
    Unverified
    Slovakia
  • —
    Unverified
    Germany

Common questions

What is a placebo?

A placebo looks just like the real medicine but contains no active drug. It helps researchers prove whether any health changes are truly caused by the study medicine.

Will I have to pay to take part?

No. The study treatment, tests, and medical visits are provided free of charge, and travel expenses are usually reimbursed.

Can I keep taking my current diabetes medications?

This depends on the specific treatments you use. The study doctor will review all your medicines to see if they are safe to continue during the trial.

What happens if I experience side effects?

The study team will monitor you closely at every visit. If you experience any side effects, the doctors will provide medical advice and care right away.

Can I leave the study if I change my mind?

Yes. You can leave the trial at any point, for any reason, and your regular doctor will continue to manage your standard 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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