Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, randomised, double-blind, parallel-group, 76-week, efficacy and safety study of BI 456906 administered subcutaneously compared with placebo in participants with overweight or obesity without type 2 diabetes

This research study is looking into a new medication called BI 456906. It's designed for people who are overweight or have obesity but don't have type 2 diabetes. The main goal is to find out how well this new medicine helps people lose weight and if it's safe to use. Some participants will receive the active medicine through an injection under the skin, while others will get a placebo (a dummy injection that looks the same but contains no medicine). The study will last for 76 weeks, which is about a year and a half, comparing the effects of the new medicine against the placebo. Researchers will carefully check changes in body weight and other health measurements during this time.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Boehringer Ingelheim International GmbH, Boehringer Ingelheim RCV GmbH & Co. KG

Enrolment target

130

Start

15 Jan 2024

Obesity

What is this study about?

This study is investigating a new medicine, BI 456906, for adults who are overweight or have obesity but do not have type 2 diabetes. The main idea behind this research is to see if this new medicine can help people lose weight and maintain that weight loss over time. The study will also carefully check for any side effects to make sure the medicine is safe.

The researchers are particularly interested in how much body weight changes from the beginning to the end of the study. They will also look at whether participants achieve specific levels of weight loss, such as losing 5%, 10%, 15%, or 20% of their starting weight. On top of weight, they'll be checking other important health markers like waist size and blood pressure, and even how eating habits might change.

This kind of study, called a Phase 3 trial, is a crucial step in developing new medicines. It means the medicine has already been tested in smaller groups and shown some promise. This larger study aims to confirm those findings in many more people, providing strong evidence about whether the medicine is effective and safe enough to potentially be used more widely in the future.

Key takeaways

This study is testing a new medicine for weight loss in adults who are overweight or have obesity.
It's for people without type 2 diabetes.
Participants will receive either the study medicine or a placebo by injection.
The study lasts about 76 weeks and involves regular health checks.
It aims to find out how well the medicine works and if it's safe.
Participation is voluntary, and you can withdraw at any time.

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.

A key requirement is that you must be considered overweight or have obesity. However, it's very important that you do not have type 2 diabetes, as the study is specifically designed for people without this condition.

There will be other health checks and criteria that the study team will discuss with you to make sure the study is a good fit for your health and safety.

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?
Are you considered overweight or do you have obesity?
Do you *not* have type 2 diabetes?
Are you willing to attend regular visits for about 76 weeks?
Are you comfortable with receiving injections under the skin?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you will be in the study for about 76 weeks, which is roughly a year and a half. During this time, you'll receive regular injections under your skin – some participants will get the study medicine (BI 456906) and others will get a placebo (a dummy injection without medicine).

You will have several scheduled visits to the clinic for health check-ups. These visits will involve various assessments, such as measuring your weight, waist circumference, and blood pressure. You might also be asked to answer questions about your eating habits. All of these measurements help the research team understand how the medicine is working and monitor your health.

After the main treatment period, there will likely be some follow-up visits to ensure your health is stable. The study team will explain the exact schedule of visits and what each visit will involve in detail.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new medication that might help with weight loss, along with careful monitoring of your health by medical professionals. However, there are also potential risks, as any new medicine can have side effects, and some people may experience no benefit from the treatment. You will be fully informed about all known risks before you decide to participate. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
Netherlands
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Unverified
Sweden
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Unverified
Poland
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Unverified
Finland
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Unverified
Belgium

Common questions

What is BI 456906?

BI 456906 is the name of the new medicine being tested in this study. It's designed to help people who are overweight or have obesity.

What is a placebo?

A placebo is a 'dummy' injection that looks exactly like the real medicine but contains no active ingredients. It helps researchers fairly compare the effects of the actual medicine.

How long will the study last?

The study will last for about 76 weeks, which is roughly a year and a half.

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

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you are receiving the active medicine or the placebo until the study is over.

Do I have to pay to be in the study?

No, clinical trials usually cover the costs of the study medication and study-related visits and tests. You should check with the study team about any potential out-of-pocket expenses.