Not yet recruitingPHASE3INTERVENTIONAL

A Study to Evaluate Effect of AZD6234 as an Adjunct to Incretin-based Therapies in Adult Participants With Obesity or Overweight With Weight-related Comorbidity With or Without Type 2 Diabetes Mellitus

This research study is looking for adults who are overweight or have obesity and also have other health problems linked to their weight, such as high blood pressure, high cholesterol, sleep apnea, or even type 2 diabetes. Participants are already taking a type of medicine called 'incretin-based therapies' for weight management. The main goal is to find out if a new medicine, AZD6234, can help people lose more weight safely when added to their current treatment. Some participants will receive AZD6234, while others will get a placebo (a dummy medicine). The study will compare the two groups to see how much their weight changes over about 68 weeks.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

500

Start

21 Aug 2026

Estimated completion

09 Aug 2028

Obesity or Overweight Weight-Related Comorbidity With/Without Diabetes Mellitus, Type 2

What is this study about?

This study is looking into a new medicine called AZD6234. It's designed for adults who are overweight or have obesity and also have other health conditions that are often linked to weight. These might include things like high blood pressure, high cholesterol, problems with breathing during sleep (sleep apnoea), or even type 2 diabetes. Many people in the study will already be taking a specific type of medicine to help manage their weight, known as 'incretin-based therapies'.

The main purpose of this research is to see how well AZD6234 works and if it's safe. It will compare AZD6234 against a 'placebo', which is a dummy medicine that looks the same but contains no active drug. Neither you nor your study doctor will know whether you're getting the active medicine or the placebo. This helps make sure the results are fair and accurate.

Over a period of about 68 weeks, the study will carefully track how participants' body weight changes. Researchers will also be looking closely at any side effects to understand the safety of the new medicine. This is a 'Phase 3' study, which means it's one of the final steps before a new medicine might become widely available.

Key takeaways

This study tests a new medicine, AZD6234, for weight management.
It's for adults with overweight/obesity and related health conditions, including some with type 2 diabetes.
AZD6234 is added to your existing weight management medication.
Participants will receive either the active drug or a placebo (dummy medicine).
The study lasts about 68 weeks and involves regular check-ups.
It aims to see if AZD6234 safely helps with more weight loss.

Who may be eligible?

To join this study, you need to be an adult (age 18 or over). You would typically be either living with obesity (a BMI of 30 or higher) or be overweight (a BMI of 27 or higher) and have at least one weight-related health problem. These health problems could be high blood pressure, high cholesterol, sleep apnoea, heart disease, kidney disease, fatty liver disease, knee arthritis, or stress incontinence.

If you have type 2 diabetes, you must have been diagnosed at least three months ago, and your blood sugar levels (HbA1c) should be within a certain range. You also need to have been on a stable dose of your current incretin-based weight management medication for at least three months, and your weight should have been stable (not changed by more than 3%) in the last three months. You also need to have tried to lose weight unsuccessfully at least once before.

You cannot join if your obesity is caused by other hormone problems, or if you have type 1 diabetes. Also, if you have significant liver problems, have used insulin for your type 2 diabetes in the last three months, or have certain blood test results outside the normal range, you would not be able 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.

Are you 18 years old or older?
Do you have a BMI of 30 or more, OR a BMI of 27 or more with a weight-related health problem (like high blood pressure or sleep apnoea)?
Are you currently taking a stable dose of an incretin-based medicine for weight management?
Have you tried to lose weight in the past but it hasn't worked out?
Do you *not* have type 1 diabetes or major liver problems?
If you have type 2 diabetes, have you been on stable medication (not insulin) for at least 3 months?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive either the new medicine (AZD6234) or a placebo (dummy medicine) as an add-on to your current weight management medicine. You would attend regular appointments at the study clinic, where the team will take measurements, blood samples, and check on your general health and how you're feeling. These visits help the researchers monitor your progress and ensure your safety.

The study treatment period will last for about 68 weeks (around a year and four months). During this time, you'll continue taking your regular weight management medicine alongside the study drug. There will also be follow-up appointments after the treatment period ends to check on your health. The study will track your weight change and any side effects over the entire duration.

Potential risks and benefits

Taking part in any clinical study has potential benefits and potential risks. A possible benefit might be that the new medicine, AZD6234, could help you manage your weight more effectively than your current treatment alone. You would also receive close medical attention and monitoring throughout the study. However, there's no guarantee you'll get the active medicine, as you might receive the placebo. There is also the possibility of experiencing side effects from the new medicine, some of which may not be fully known yet. The study team will explain all known risks to you. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (88)

Research Site
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Escondido, United States
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Lincoln, United States
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Walnut Creek, United States
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Fleming Island, United States
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Jacksonville, United States
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Stockbridge, United States
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Woodstock, United States
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Champaign, United States
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Chicago, United States
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Beltsville, United States
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Oxon Hill, United States
Research Site
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Kansas City, United States

Common questions

What is AZD6234?

AZD6234 is a new medicine being tested to see if it helps adults who are overweight or have obesity manage their weight, especially when added to other weight loss treatments.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real medicine but doesn't contain any active drug. It's used in studies to compare against the new medicine fairly.

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

No, during the study, neither you nor your study doctor will know whether you are receiving AZD6234 or the placebo. This is to ensure unbiased results.

How long would I be in the study?

The main treatment part of the study lasts for about 68 weeks (around 1 year and 4 months), with some follow-up appointments afterwards.

What does 'incretin-based therapies' mean?

These are a type of medicine you might already be taking that helps with weight management, often by affecting how your body handles sugar or how full you feel.

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.