Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A PilOt dose-escalation trial with EMP16 in preparation for Phase III – the POEM trial

This study, called POEM, is looking for people with obesity to test a new treatment. We want to see how a new medicine, EMP16 (taken with a fiber supplement called Vi-Siblin S), compares to a common weight-loss medicine, Orlistat (taken with a fake fiber supplement). We'll be focusing on any stomach or bowel issues people might experience, such as oily spotting, loose stools, or diarrhoea. This will help us understand if the new treatment has fewer side effects and could be a good option for future weight management.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Empros Pharma AB

Enrolment target

Start

22 Apr 2025

Obesity

What is this study about?

This study, called the POEM trial, is designed for people who are living with obesity. We're trying to find better ways to help people manage their weight, and sometimes current medications can cause uncomfortable side effects, especially with their digestion.

In this study, we are testing a new treatment called EMP16. We want to see how it compares to a widely used medicine called Orlistat, which many people might know as Alli capsules. Both treatments will be given alongside a fibre supplement: EMP16 with Vi-Siblin S, and Orlistat with a 'dummy' fibre supplement (maltodextrin, which looks like the real thing but has no active ingredients).

The main thing we want to understand is whether EMP16 causes fewer stomach and bowel problems compared to Orlistat. We'll be carefully looking at things like oily spotting, accidental bowel movements, and diarrhoea. By doing this, we hope to find a treatment that is not only effective for weight management but also much kinder on your tummy.

Key takeaways

This study compares a new weight-loss medicine (EMP16) to a standard one (Orlistat).
It aims to find treatments that are easier on your stomach and bowels.
Participation involves taking medication and regular clinic visits.
People aged 18 or over with obesity can take part.
You will be closely monitored by a medical team.

Who may be eligible?

This study is for adults aged 18 and over, and we welcome both men and women to take part. The main requirement is that you are living with obesity. We'll need to check your medical history to make sure this study is right for you and that you don't have any conditions that might make it unsafe.

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 obesity?
Are you comfortable discussing your health and any side effects?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given either the new treatment (EMP16 with Vi-Siblin S) or the standard treatment (Orlistat with a 'dummy' fibre supplement). You wouldn't know which one you are getting. You would be asked to take the medication as instructed and follow a healthy diet.

Over several weeks, you would have regular visits to the clinic. During these visits, we would ask you about any stomach or bowel issues you've had, like oily spotting or diarrhoea. We would also keep track of any other side effects you might experience. These assessments help us understand how well the treatments are working and how you are feeling. The total time you would be involved in the study would be shared with you by the study team.

Potential risks and benefits

Taking part in a study like this means you might benefit from close monitoring of your health and access to a new potential treatment. However, there are also potential risks, such as experiencing side effects from the medication, even if they are mild. You can stop taking part in 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
Sweden

Common questions

What is EMP16?

EMP16 is a new experimental medicine being tested in this study to help people with obesity.

What is Orlistat (Alli)?

Orlistat, also known as Alli, is a well-known medicine used to help people lose weight by blocking some of the fat their body absorbs.

What are 'stomach and bowel issues'?

These are common side effects with some weight-loss medicines. We'll be looking out for things like oily spotting, accidental loose stools, and diarrhoea.

Will I know which treatment I'm getting?

No, this is a 'blinded' study, meaning neither you nor the study team will know which treatment you are receiving until the study is over.

How long will the study last?

The exact duration for your participation will be explained in detail by the study team before you join.