Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A randomised, placebo-controlled, double-blinded, cross-over, Phase 1 study evaluating the safety and preliminary efficacy of the GLP 1 analogue ROSE-010 on appetite and food intake in overweight and obese subjects.

This study is looking into a new investigational medicine called ROSE-010. It's designed for people who are overweight or obese. This is a very early-stage study, called a Phase 1 study, which means its main goals are to check if the medicine is safe and to see what effects it has on the body, especially on appetite and how much food people eat. We want to understand if ROSE-010 could help people manage their weight. Participants will be given either the new medicine or a dummy medicine (placebo) at different times, without knowing which they are receiving, so we can fairly compare the effects.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Rose Pharma Inc.

Enrolment target

Start

09 Nov 2023

Overweight Obesity

What is this study about?

This study is about exploring a new medicine named ROSE-010. It's being developed as a potential way to help people who are overweight or obese manage their weight. The medicine works similarly to a natural body chemical called GLP-1, which plays a role in controlling appetite and how much food we eat.

This is a 'Phase 1' study, which is the very first step in testing a new medicine in people. At this stage, our main focus is on safety – making sure the medicine doesn't cause serious side effects. We also want to get an early idea of how the medicine affects the body, particularly if it can help reduce appetite and food intake.

Understanding how new medicines like ROSE-010 affect appetite is important because it could lead to new ways to support people in reaching and maintaining a healthy weight. By taking part, you would be contributing valuable information that could help in the development of future treatments.

Key takeaways

This study is testing a brand-new medicine called ROSE-010 for people who are overweight or obese.
It's a very early study (Phase 1) focused on safety and initial effects on appetite.
Participants will receive either the active medicine or a dummy pill, without knowing which.
The study aims to understand if ROSE-010 could help manage weight by affecting how much people eat.
Your participation could help advance future treatments for weight management.
You can stop participating at any time without affecting your normal healthcare.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

The main health requirements are that you are currently considered overweight or obese. There will be specific medical checks to make sure this study is suitable and safe for you.

Other specific health conditions or medications you might be taking could mean you are not able to join, as the researchers need to ensure the study is safe and the results are clear. All these details will be discussed with you thoroughly if you are interested.

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 obese?
Are you able to attend appointments at a study clinic?
Are you generally healthy, apart from being overweight or obese?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given either the new medicine, ROSE-010, or a dummy medicine (placebo) at different times during the study. Neither you nor your study doctor will know which you are receiving at any given time. This is called 'double-blinded' and helps us get fair results.

You will have several scheduled visits to the study clinic where various assessments will be done. These will likely include health checks, blood tests, and questions about your appetite and how much food you eat. You will receive the study medicine during these visits and there will be follow-up appointments to monitor your health and how you're feeling. The total duration of your involvement in the study will be explained in full detail by the study team.

Potential risks and benefits

Potential benefits of taking part include contributing to medical research that could help others in the future and receiving close medical attention during the study. However, there's no guarantee that by taking part, you will personally benefit from the new medicine. As with any medicine, there's a chance of side effects, which could range from mild to more serious. All known risks will be clearly explained before you decide to join. Remember, taking part is completely 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
Sweden

Common questions

What does 'Phase 1 study' mean?

It means this is the first time the medicine is being tested in people. The main goals are to check if it's safe and how it affects the body.

What is GLP-1?

GLP-1 is a natural hormone in your body that helps control your appetite and tells you when you're full.

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

No, during the study, neither you nor the doctors will know. This is to make sure the results are fair and accurate.

What happens if I want to stop taking part?

You can leave the study at any time, for any reason. Your decision will not affect your regular medical care.

What are the main goals of this study?

To see if the new medicine, ROSE-010, is safe for people to take and if it has any early effects on appetite and how much food they eat.