Not yet recruitingPHASE3INTERVENTIONAL

A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM

This research is testing a new drug called Elecoglipron to see if it's safe and effective for weight management. It's designed for adults who are living with obesity or are overweight, with some related health issues. The study is split into two parts: one for people who don't have Type 2 diabetes, and another for people who do. Participants will take Elecoglipron or a dummy pill daily alongside their usual diet and exercise. The main goal is to check how much weight people lose over 72 weeks. This is a large study involving many different hospitals and clinics worldwide, aiming to understand the full benefits and potential side effects of this new treatment.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

4,500

Start

06 Jul 2026

Estimated completion

30 Jul 2029

Weight Management

What is this study about?

This study is looking into a new medicine called Elecoglipron. It's being developed to help adults manage their weight, specifically those who are living with obesity or are overweight and have other health problems linked to their weight. The idea is that Elecoglipron, taken as a tablet once a day, could be a useful addition to changes in diet and exercise.

This research is a 'Phase III' study, which means it's one of the final stages of testing a new medicine before it might be considered for general use. It's a large and important step to make sure the treatment is both safe and works well. The study is also 'randomized' and 'double-blind'. This means some people will get the active medicine, and others will get a placebo (a dummy pill with no medicine in it), but neither you nor your doctor will know which you are receiving. This helps make sure the results are fair.

The study has two main parts. One part is for people who are overweight or have obesity and have certain weight-related health conditions (like high blood pressure or prediabetes) but *do not* have Type 2 diabetes. The other part is for people who are overweight or have obesity *and* have Type 2 diabetes. The main thing the researchers want to find out is how much weight people lose after about 72 weeks (around a year and a half). They will also be carefully monitoring for any side effects.

Key takeaways

This study is testing a new weight management medicine called Elecoglipron.
It's for adults with obesity or overweight, with or without Type 2 diabetes.
Participants will follow a diet and exercise plan alongside the study medication or a placebo.
The main aim is to see how much weight people lose over 72 weeks and check for safetly.
It's a 'double-blind' study, meaning you won't know if you're taking the active drug or a dummy pill.
Your health will be closely monitored throughout the study.

Who may be eligible?

To join this study, you need to be at least 18 years old. For those without Type 2 diabetes, you would need to have a Body Mass Index (BMI) of 30 or higher (considered obesity), or a BMI between 25 and 30 (considered overweight) along with at least one weight-related health condition like high blood pressure, prediabetes, high cholesterol, heart disease, or sleep apnoea.

If you have Type 2 diabetes, you would need a BMI of 25 or higher. Everyone considered for the study should have had a stable weight for the past three months and have tried to lose weight through diet before but haven't been successful.

There are also some reasons why you couldn't join. For example, if you have Type 1 diabetes, or if your Type 2 diabetes is not well controlled (very high blood sugar levels) or causing certain complications. You also cannot have a history of certain serious conditions like acute or chronic pancreatitis, or a personal or close family history of a rare type of thyroid cancer.

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 obesity (BMI 30+) or are you overweight (BMI 25+) with a weight-related health issue?
If you don't have Type 2 diabetes, do you have high blood pressure, prediabetes, high cholesterol, heart disease, or sleep apnoea?
If you have Type 2 diabetes, is it well-managed without certain complications?
Have you tried losing weight through diet in the past without success?
Has your weight been stable for the last three months?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be involved in the study for over a year. You would be randomly assigned to receive either Elecoglipron or a placebo (a dummy pill), and you would take your assigned tablet once a day. You would also be asked to follow a diet and exercise plan designed for weight management. Throughout the study, you would have regular visits to the clinic for health check-ups, blood tests, and to monitor your weight and overall health. The main assessment would be your body weight change over 72 weeks.

Potential risks and benefits

Participating in this study might offer you the potential benefit of losing weight and improving your health under careful medical supervision. However, like all medications, Elecoglipron may have side effects, which would be monitored closely. There are also risks associated with clinical trials, such as the inconvenience of appointments or the possibility of not receiving the active drug. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (132)

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Birmingham, United States
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Chandler, United States
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Lincoln, United States
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Clearwater, United States
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Woodstock, United States
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Indianapolis, United States
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Louisville, United States
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Baltimore, United States
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Potomac, United States
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Ypsilanti, United States
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Kansas City, United States
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Albany, United States

Common questions

What is Elecoglipron?

Elecoglipron is a new medication being tested to help people manage their weight when combined with diet and exercise.

Who can take part in this study?

Adults aged 18 and over who are overweight or have obesity, with or without Type 2 diabetes, and who meet other specific health criteria.

Will I know if I'm getting the real medicine or a dummy pill?

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

How long will the study last?

Your participation in the study would last for about 72 weeks, which is roughly a year and a half.

What if I want to stop participating?

You are free to leave the study at any time, for any reason, without it affecting your medical care.

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.