AuthorisedTherapeutic use (Phase IV)Interventional

Effect of an adjunctive intervention on the tolerability of semaglutide in overweight adults without diabetes: a prospective, randomised, double-blind, single-centre, placebo-controlled clinical trial (SEMTOL)

This research study, called SEMTOL, is exploring how to make a weight management medicine, semaglutide, easier to take for adults who are overweight. Sometimes, semaglutide can cause nausea (feeling sick), especially when people first start taking it. In this study, we are testing if adding a third medicine helps reduce this sickness during the first four days of treatment. We'll compare how people feel when taking semaglutide with this extra medicine versus semaglutide with a dummy pill. We'll also look at changes in weight, appetite, and any other side effects, to understand how well semaglutide is tolerated.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

University Of Tartu

Enrolment target

100

Start

21 May 2026

Overweight and obesity

What is this study about?

This study, known as SEMTOL, is designed for adults who are overweight but don't have diabetes. We're focusing on a medication called semaglutide, which is used to help people manage their weight. While semaglutide can be effective, some people find that it causes side effects, particularly nausea (feeling sick), when they first start taking it. This can make it difficult for them to continue treatment.

The main goal of this study is to find out if taking an additional medicine can help reduce this nausea. We want to make it easier for people to tolerate semaglutide during the first four days after they've taken their dose. To do this, we'll be asking participants to rate how sick they feel on a simple scale from 0 to 10 (where 0 is no sickness and 10 is the worst sickness) during these first few days.

Beyond just nausea, we will also be looking at overall well-being, how much of any other study medicine people take, and whether their body weight and appetite change. We'll also keep an eye out for other common side effects like vomiting, constipation, diarrhoea, stomach pain, dizziness, tiredness, and headaches. By understanding these effects better, we hope to improve the experience for people using semaglutide for weight management in the future.

Key takeaways

The study aims to make semaglutide a more comfortable weight management option.
It tests if an extra medicine can reduce nausea from semaglutide.
Participants are adults who are overweight but don't have diabetes.
Your experience of nausea and other side effects will be carefully monitored.
It's a 'blinded' study, meaning you won't know which treatment you receive.

Who may be eligible?

This study is looking for adults who are at least 18 years old. People of any gender can take part.

To be eligible, you must be overweight but you should not have diabetes. This study is specifically for individuals who are otherwise generally healthy and interested in managing their weight.

There might be other health requirements or conditions that could prevent you from joining, which the study team will discuss 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?
Are you considered overweight?
Do you *not* have diabetes?
Are you generally in good health otherwise?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given different medications to take. Some will be semaglutide, and others will be either a medicine to help with nausea or a dummy pill (placebo – a pill with no active ingredient). You won't know which one you're getting, and neither will the study team. You'll need to accurately track how much of any oral study medicine you take each day.

Throughout the study, you'll be asked to regularly rate your nausea and your overall well-being using simple rating scales. The study team will also monitor your body weight, appetite, and check for any other side effects you might experience, like vomiting or headaches. You will attend a single center for all your study visits and assessments.

Potential risks and benefits

Taking part in this study could offer the potential benefit of finding new ways to make weight management medication more tolerable, which could help yourself or others in the future. However, there are potential risks, such as experiencing side effects from the medications, including nausea, vomiting, or other discomforts. You have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Estonia

Common questions

What is semaglutide?

Semaglutide is a medicine that helps manage weight. It can also be used for diabetes, but in this study, we are focusing on its use for overweight individuals without diabetes.

What does 'tolerability' mean in this study?

Tolerability means how well you can take a medicine without experiencing unpleasant side effects. In this study, we're especially focused on how much nausea (feeling sick) people experience.

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

No, this is a 'double-blind' study. This means neither you nor the study team will know whether you are receiving the active additional medicine or a dummy pill. This helps ensure fair and unbiased results.

What is the '0-10 numeric rating scale (NRS)'?

It's a simple way to measure how you feel. You'll just need to choose a number from 0 (no sickness) to 10 (the worst sickness you can imagine) to describe your nausea.

How long will I be in the study?

The study focuses on your experience mainly during the first 96 hours (four days) after taking semaglutide, but includes follow-up assessments for other outcomes like body weight and side effects.