Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE ASCENDING DOSE PHASE 1 STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETIC, AND PHARMACODYNAMIC PROFILE OF RES-010 IN HEALTHY, OVERWEIGHT, AND MODERATELY OBESE SUBJECTS

This early-stage study is looking into a new medicine called RES-010, designed to help with obesity. Researchers want to understand if it's safe to use and how the body handles it at different dose levels. They'll also check if it has any effects on the body. Participants will be healthy adults who are overweight or moderately obese. Some will receive the new medicine, while others will get a placebo (a dummy pill with no active ingredient). Neither the participants nor the doctors will know who is getting which, to ensure fair results. This type of study is crucial to understand if new medicines are promising enough for further testing.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Resalis Therapeutics S.r.l.

Enrolment target

Start

08 Oct 2024

Obesity

What is this study about?

This study is an early but very important step in developing a new medicine for obesity, called RES-010. When a new treatment is discovered, it must go through several stages of testing to make sure it's safe and effective before it can be used widely. This particular study is called a 'Phase 1' study, which means it's one of the very first times this medicine will be given to people.

The main goals of this study are to find out if RES-010 is safe for people, how much of it the body can handle without causing problems, and how the body processes the medicine (how it absorbs, distributes, breaks down, and gets rid of it). They also want to see if it has any noticeable effects on the body. To do this, some participants will receive different doses of RES-010, starting with a very small amount and gradually increasing it, while others will receive a 'placebo' – a pill that looks exactly like the study medicine but contains no active drug. This helps researchers understand the true effects of RES-010.

This is a 'double-blind' study, which means neither the participants nor the study doctors will know whether someone is receiving the actual medicine or the placebo. This is a standard and important way to ensure the results are as unbiased and accurate as possible. The information gathered from this study will help decide if RES-010 should be tested further in larger studies.

Key takeaways

This is an early-stage study for a new obesity medicine called RES-010.
The main focus is on checking the medicine's safety and how the body handles it.
Healthy adults who are overweight or moderately obese are invited to participate.
Participants will receive either the new medicine or a dummy pill (placebo).
Neither you nor your doctor will know which treatment you are receiving.
Your participation helps advance research into new treatments for obesity.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

Participants must be generally healthy overall, but at the same time, they need to be either overweight or moderately obese. This means your body mass index (BMI) will be in a certain range that the researchers are looking for.

There will be other health checks and criteria to make sure it's safe for you to take part and that your involvement will help the researchers get clear results. These will be explained in full by the study team if you express interest.

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 generally healthy, but considered overweight or moderately obese?
Are you able to attend regular clinic visits?
Are you comfortable with the possibility of receiving a 'dummy' pill?
Are you willing to have regular health checks, including blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have several scheduled visits to the study clinic over a period of time. These visits will involve various assessments, such as physical examinations, blood tests, and other measurements to check your health and how the study medicine is affecting your body. You will be given either the new medicine, RES-010, or a placebo (a dummy pill) to take as directed by the study team. You will not know which one you are receiving. The study will involve both single doses and taking the medicine multiple times over a period. After you stop taking the medicine, there will be follow-up visits to ensure your health is stable. The total duration of your participation in the study will be explained in detail by the study team, as it varies depending on which part of the study you are in.

Potential risks and benefits

Potential benefits of participating are contributing to scientific knowledge that could lead to new treatments for obesity. While there is no guarantee of direct personal benefit from the new medicine, you will receive close medical monitoring. Potential risks include side effects from the study medicine, which are currently unknown but will be closely watched for. There's also the time commitment and discomfort from procedures like blood tests. You have the right to withdraw from the study at any time, for any reason, without it affecting your future 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
Netherlands

Common questions

What is RES-010?

RES-010 is a new medicine being tested as a potential treatment for obesity.

What does 'double-blind' mean?

It means neither you nor the study doctors will know if you're getting the actual medicine or a dummy pill (placebo).

Why include a 'placebo'?

Using a placebo helps researchers see the real effects of the medicine, by comparing it to people who didn't get the active drug.

Will I lose weight on this study?

The main goal of this early study is to check safety and how the body handles the medicine, not necessarily weight loss. There's no guarantee you will lose weight.

Can I stop participating if I want to?

Yes, you are free to leave the study at any time without giving a reason, and it won't affect your medical care.