AuthorisedTherapeutic exploratory (Phase II)Interventional

Weight management with orismilast alone or in combination with s.c. semaglutide (WELOSITI)

This research study, called WELOSITI, is exploring a new medication called orismilast, either on its own or combined with another medicine, semaglutide, to help people with obesity manage their weight. It's a phase II study, meaning it's still in the earlier stages of testing to see how well it works and if it's safe. The main goal is to measure how much a person's body weight changes over 16 weeks while taking the study medication. Researchers will also look at other health markers like blood pressure, body fat, and inflammation. This study accepts adults aged 18 and older, regardless of gender, to participate.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Gentofte Hospital

Enrolment target

Start

21 Jan 2025

obesity

What is this study about?

This study, known as WELOSITI, is a clinical trial focusing on new ways to help people with obesity manage their weight. Researchers are testing a new medicine called orismilast. They want to see if orismilast works well on its own, or if it's more effective when combined with another common weight management medicine, semaglutide. For comparison, some participants will receive a placebo, which looks exactly like the study medicine but doesn't contain any active ingredients. This helps researchers understand if the new medicines are truly making a difference.

The main thing the researchers want to find out is how much people's body weight changes over 16 weeks while taking the assigned treatment. They will also be looking at several other important health measures. This includes changes in overall weight and body mass index (BMI), how much fat is in the body, and measurements like waist circumference. They will also check blood pressure and look for changes in certain substances in the blood that can be signs of inflammation, which is how your body responds to injury or illness.

Understanding how these medicines affect weight loss and other health markers is very important for finding better ways to support people in managing their weight and improving their overall health. Studies like WELOSITI help doctors learn more about potential new treatments, so they can offer more options to patients in the future.

Key takeaways

This study is testing a new medicine, orismilast, for weight management.
It will involve taking either orismilast alone, or with another medicine called semaglutide, or a placebo.
The main goal is to see how much weight people lose over 16 weeks.
Researchers will also track other health changes like blood pressure and body fat.
It's open to adults aged 18 and over who have obesity.
Participation involves regular clinic visits and health checks.

Who may be eligible?

This study is looking for volunteers who are adults, meaning they must be 18 years old or older. There is no upper age limit, so people of all adult ages can be considered.

Both men and women are welcome to take part in this study. The researchers want to include a diverse group of people to ensure the results are widely applicable.

To be considered, you would need to have a clinical diagnosis of obesity. The research team will review specific health information to make sure the study is a good fit for 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?
Have you been diagnosed with obesity?
Are you comfortable committing to 16 weeks of study visits?
Are you comfortable taking a study medication, which might be a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to make sure you meet all the requirements. This might include health checks and discussions about your medical history.

Once enrolled, you would be asked to take a study medication, which would be either orismilast, a combination of orismilast and semaglutide, or a placebo (an inactive tablet). This study lasts for 16 weeks. Throughout this time, you would have regular visits to the clinic. During these visits, the research team would monitor your health, take measurements like your weight, blood pressure, and waist size, and collect blood samples to check for various health markers.

You would also be asked about any changes in your health or any side effects you might experience. After the 16-week treatment period, there would likely be a follow-up visit to see how you are doing.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as receiving a new investigational medication that could help with weight management, or receiving a known medication in combination with the new one. You would also receive close medical attention and monitoring throughout the study. However, like all medications, the study drugs may have side effects, and some are not yet fully known. There's also a chance the treatment may not work for you, or that you might receive a placebo. 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 obesity?

Obesity is a medical condition where you have excess body fat that can increase your risk of health problems. It's usually measured using your Body Mass Index (BMI).

What is a 'Phase II' study?

A Phase II study is an early stage of clinical research. It mainly checks if a new treatment is safe and effective in a small group of people, before larger studies begin.

What is a placebo?

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

What is semaglutide?

Semaglutide is a medication that is already approved for managing type 2 diabetes and sometimes for weight management, depending on specific health guidelines.

What are 'inflammatory markers'?

Inflammatory markers are substances in your blood that can show if there's inflammation (swelling or irritation) in your body. Doctors might check these to understand your overall health.