Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Dapiglutide for the treatment of obesity (DREAM): a randomised, double-blind, placebo-controlled, investigator-initiated trial

The DREAM study is researching a new medicine, dapiglutide, to see if it can help people with obesity lose weight. This is an early-stage study, known as 'Phase II,' which means researchers are primarily exploring how well the drug works and if it's safe. Participants will be randomly given either dapiglutide or a dummy pill (placebo), and neither they nor their doctors will know who is getting what. The main thing researchers will look at is how much body weight changes. They will also measure other things like if people lose 5% or more of their body weight, and check markers in the blood related to gut health and inflammation. Anyone aged 18 or over, male or female, who has obesity might be able to take part.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Gentofte Hospital

Enrolment target

Start

07 Feb 2023

Obesity

What is this study about?

The DREAM study is exploring a new potential treatment for obesity called dapiglutide. Obesity is a serious health condition that can lead to many other health problems, so finding effective new treatments is very important. This study is in an early phase (Phase II), which means it's one of the first times this specific medicine is being tested in a larger group of people. The main goal at this stage is to see if dapiglutide can help people lose weight safely and effectively.

To do this, the study will compare dapiglutide to a 'placebo.' A placebo is an inactive substance, often a sugar pill, that looks just like the real medicine but contains no active drug. Participants will be randomly assigned to receive either dapiglutide or the placebo. This setup, where neither the patient nor the doctor knows who is getting what, is called 'double-blind' and helps ensure the results are as fair and unbiased as possible.

The researchers will primarily track how much participants' body weight changes over time. They will also look at whether a significant number of participants achieve a weight loss of 5% or more, as this level of weight loss is known to have health benefits. Additionally, they will study how the medication affects certain markers in the blood linked to gut health and overall inflammation in the body. Understanding these effects can give us more clues about how dapiglutide works and its broader impact on health.

Key takeaways

This study is testing a new medication called dapiglutide for obesity.
It's an early-stage study (Phase II) to see if the drug works and is safe.
You might receive the new medication or a dummy pill (placebo).
Researchers will mainly measure changes in body weight.
The study is for adults aged 18 and over, both men and women, with obesity.
Participation involves regular clinic visits and health checks.

Who may be eligible?

To be able to take part in the DREAM study, you need to be at least 18 years old. There is no upper age limit, so people of all adult ages can be considered. The study is open to both men and women.

Above all, the study is for people who have been diagnosed with obesity. This means the researchers are specifically looking for individuals who fit the medical definition of obesity to see how the new medication, dapiglutide, affects this condition. If you don't have obesity, then this specific study wouldn't be suitable for you.

Because this is an early-stage study, there will likely be other specific health requirements or conditions that might prevent someone from joining, even if they meet the basic age and obesity criteria. These are put in place to ensure the safety of participants and the accuracy of the study results. Your doctor or the study team would discuss all these details with 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.

Are you 18 years old or older?
Do you have a diagnosis of obesity?
Are you male or female?
Are you willing to attend regular clinic visits?
Are you comfortable with potentially receiving a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the DREAM study, you would first have screening visits to confirm you fit all the study requirements. Once enrolled, you would be randomly assigned to receive either the study medication (dapiglutide) or a placebo (a dummy pill). You would take this medication regularly as instructed by the study team.

Throughout the study, you would have several scheduled visits to the clinic or hospital. During these visits, the study team would: weigh you, take blood samples to check your general health, gut health markers, and inflammation levels, ask you questions about how you are feeling and any side effects you might be experiencing, and provide you with your study medication. The study will involve regular follow-up over a set period, which the study team will explain fully. The entire participation, including all visits and follow-up, will have a total duration that the research team will outline for you in detail.

Potential risks and benefits

Taking part in the DREAM study might offer potential benefits, such as receiving a new investigational treatment for obesity that could help with weight loss. Even if you receive the placebo, you will be closely monitored by medical professionals. However, as with any new medication, there are potential risks and side effects that are not yet fully known. These will be carefully explained to you, and the study team will monitor you closely for any issues. It's very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Denmark

Common questions

What is 'Phase II'?

Phase II means it's an early stage for testing a new drug. Researchers are looking to see if it works and to check for potential side effects in a larger group of people than in Phase I.

What is a 'placebo'?

A placebo is a substance that looks like the real medicine but doesn't contain any active drug. It helps researchers compare the new medicine's effects accurately.

Why is 'double-blind' important?

Double-blind means neither you nor your doctor will know if you're getting the active drug or the placebo. This helps prevent bias and ensures results are fair.

What does 'obesity' mean in this study?

In this study, 'obesity' refers to a specific medical diagnosis that the researchers are aiming to treat with the new medication. They'll check if you meet these exact criteria.

Can I leave the study if I change my mind?

Yes, absolutely. Your participation is voluntary, and you can withdraw from the study at any time without needing to give a reason, and it won't affect your medical care.