Not yet recruitingPHASE3INTERVENTIONAL

A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight

This research study is testing a new medicine called AZD6234. It's for adults in the UK who have Type 2 diabetes and are also considered overweight or have obesity. The main goal is to find out how well this new medicine works to help people lose weight, and to check its safety, compared to a placebo (a dummy medicine with no active ingredients). Participants will take either the new medicine or the placebo for a set period, and doctors will carefully monitor their health and weight changes over about 68 weeks. This is a 'Phase 3' study, which means it's one of the final steps before a medicine might be considered for wider use.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

1,500

Start

21 Aug 2026

Estimated completion

09 Aug 2028

Obesity or Overweight Diabetes Mellitus, Type 2

What is this study about?

This research study is exploring a new investigational medicine, AZD6234. It’s designed for adults who live with Type 2 diabetes and are also overweight or have obesity. The study aims to understand two main things: first, how effective the medicine is at helping people reduce their body weight, and second, to ensure it is safe to use. Researchers will compare AZD6234 with a 'placebo' – this is an inactive substance that looks exactly like the study medicine but contains no active ingredients. This comparison helps researchers truly understand the effect of the new medicine itself.

This is a 'Phase 3' study. This means it's a large-scale study involving many participants across different locations (a 'multicentre' study). It's a crucial step in the medicine development process, as it gathers a lot of information on how well the medicine works and its safety before it could potentially be made available to more people. The study will last for about 68 weeks.

Participants will be randomly assigned to either receive AZD6234 or the placebo. This 'random' assignment, along with the study being 'double-blind' (meaning neither the participant nor the study staff will know who is getting which treatment), helps ensure the study results are fair and unbiased. Your participation could help medical science learn more about new ways to manage Type 2 diabetes and weight.

Key takeaways

This study is testing a new medicine, AZD6234, for weight loss in adults with Type 2 diabetes.
It aims to check both how well it works and its safety.
Participants will receive either the new medicine or a dummy medicine (placebo).
The study lasts about 68 weeks with regular clinic visits.
It's a 'Phase 3' study, a crucial step in medicine development.
Your involvement could help advance understanding of diabetes and weight management.

Who may be eligible?

To join this study, you would need to be an adult (18 years or older) and have Type 2 diabetes that was diagnosed at least 3 months ago. You would also need to be considered overweight or to have obesity, which is measured using something called your Body Mass Index (BMI). Specifically, your BMI needs to be 27 kg/m2 or higher. Your diabetes should be reasonably controlled, meaning your HbA1c (a measure of blood sugar over time) falls within a certain range, and you should be managing it with diet and exercise, or with stable doses of certain diabetes medicines (not including insulin for the last 3 months).

There are also some reasons why you might not be able to join. For example, if your obesity is mainly due to other hormone problems, or if you have Type 1 diabetes. You also can't have serious liver problems or certain blood test results that suggest liver issues. If you've used certain diabetes medications (like GLP-1 medicines) or insulin in the last 3 months, you wouldn't be able to participate. You would also need to have tried to lose weight before, without success, and your weight should have been stable (not changed much) in the 3 months before starting the study.

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.

Are you 18 years old or older?
Have you been diagnosed with Type 2 diabetes for at least 3 months?
Are you considered overweight or to have obesity (BMI of 27 or higher)?
Do you manage your diabetes with diet/exercise or stable diabetes pills (not insulin for the last 3 months)?
Have you tried to lose weight before without success?
Do you have stable body weight (not changed much) for the last 3 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first go through a screening process to make sure you're a good fit. If you qualify, you will be randomly assigned to either take the new medicine, AZD6234, or a placebo (a dummy medicine) – neither you nor the study team will know which one you are getting. You'll take this medicine regularly for about 68 weeks, which is roughly a year and a half. During this time, you'll have regular visits to the clinic for check-ups. These visits will involve various assessments, such as blood tests, physical examinations, and weight measurements, to track your health, how your body is responding to the treatment, and to check for any side effects. There will also be follow-up appointments after your treatment period. The total duration of your involvement, including screening and follow-up, will be clearly explained by the study team.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. A potential benefit is that the new medicine, AZD6234, might help you with weight loss and potentially improve your Type 2 diabetes management. You would also receive regular medical attention and monitoring throughout the study. However, there are potential risks, including side effects from the study medicine or the placebo, which could be mild or more serious. There's also the chance the medicine might not work for you, or you could be assigned to the placebo group. All procedures, like blood tests, carry small risks. Your safety and well-being are a top priority, and you will be closely monitored. Remember, participating is always voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (218)

Research Site
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Fairhope, United States
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Huntsville, United States
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Mesa, United States
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Phoenix, United States
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Tucson, United States
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Little Rock, United States
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Bakersfield, United States
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Gardena, United States
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Lincoln, United States
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Torrance, United States
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Walnut Creek, United States
Research Site
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Coral Gables, United States

Common questions

What is Type 2 diabetes and how does it relate to weight?

Type 2 diabetes is a common condition where your body either doesn't produce enough insulin, or the insulin it does produce isn't working properly. Insulin is a hormone that helps sugar get into your cells for energy. Being overweight or having obesity can make it harder for your body to use insulin effectively, often making Type 2 diabetes worse.

What is a 'placebo' and why is it used?

A placebo is a dummy medicine that looks exactly like the real study medicine but has no active ingredients. It's used so that researchers can fairly compare the effects of the new medicine against what happens when people think they are getting treatment but aren't. This helps them see if the new medicine really works.

What does 'Phase 3' mean for a medicine study?

Phase 3 is one of the final stages of testing a new medicine before it can be considered for wider use. These studies involve many people and aim to confirm how well the medicine works, compare it to existing treatments or a placebo, and further check its safety over a longer period.

Will I know if I'm getting the new medicine or the placebo?

No, neither you nor your study doctor will know if you are receiving the new medicine (AZD6234) or the placebo. This is called a 'double-blind' study and helps make sure the study results are as fair and accurate as possible.

Can I stop participating in the study if I change my mind?

Yes, absolutely. Taking part in any research study is always voluntary. You can choose to withdraw at any point, for any reason, without it affecting your future medical care. You just need to let the study team know.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.