Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Semaglutide and Granisetron for Tolerability in Overweight Adults Without Diabetes

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is being done in adults with overweight and obesity who do not have diabetes. The study looks at semaglutide, a medicine given as a subcutaneous injection under the skin, and compares it with a placebo. Some people also receive granisetron, a medicine taken by mouth. The purpose of the study is to see whether the extra medicine can help people tolerate semaglutide better.

The study follows a short treatment period after semaglutide is given. During this time, the study team checks how well the medicine is tolerated and records common stomach and body symptoms such as nausea, vomiting, constipation, diarrhoea, abdominal pain, dizziness, fatigue, headache, appetite changes, and changes in body weight. The main focus is on how strong nausea is during the first few days after treatment.

The trial is randomised, which means the study treatment is assigned by chance, and double-blind, which means neither the participants nor the study team know who receives which treatment during the study. The trial is also placebo-controlled, so one group receives placebo instead of the active added medicine.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study treatment begins

    After joining the study, you receive semaglutide as a 0.75 mg subcutaneous injection. A subcutaneous injection is given under the skin.

    You also start taking granisetron by mouth at a dose of 2 mg. This oral medicine is the background treatment, meaning it is given alongside the study treatment.

    The study also includes a placebo made of rice flour. A placebo is a substance without active medicine.

  2. Step 2

    First 96 hours after semaglutide

    During the first 96 hours after you receive semaglutide, your nausea is measured using a 0 to 10 numeric rating scale. On this scale, 0 means no nausea and 10 means the worst possible nausea.

    Your tolerability of the treatment is assessed during this period by looking at the severity of nausea.

  3. Step 3

    Daily follow-up during treatment

    You report your daily well-being using a numerical rating scale.

    You record whether you use the daily oral study medication.

    Your appetite is checked for changes.

    Your body weight is measured for change from the starting point.

    Any side effects are noted, including vomiting, constipation, diarrhoea, abdominal pain, dizziness, fatigue, and headache.

Who can join the trial?

20 criteria

  • Be an adult between 18 and 70 years old.
  • Have overweight based on body mass index, also called BMI, which is a measure of body weight compared with height:
    • BMI 30 to 35 kg/m², or
    • BMI 27 to 30 kg/m² and at least one health problem related to excess weight, such as:
      • High blood pressure (hypertension)
      • A history of heart or blood vessel disease, such as heart attack (myocardial infarction), stroke, or heart failure
      • Metabolic dysfunction-associated steatotic liver disease, which means fat buildup in the liver
      • Osteoarthritis, which is joint wear and pain
      • Sleep apnoea, which means repeated pauses in breathing during sleep
      • Have not used semaglutide, another GLP-1 receptor agonist (a medicine that acts like a gut hormone), or acamprosate during the last 3 months.
      • Have not used antiemetics (medicines that prevent nausea and vomiting), laxatives (medicines that help bowel movements), or gastrointestinal modulators (medicines that change how the stomach and intestines work) during the last 2 months.
      • Be not currently taking any medicine that affects stomach or bowel function.
      • Have no diabetes and no other serious long-term illness.
      • If a woman can become pregnant, agree to use effective birth control during the whole study. Acceptable methods include:
        • Hormonal contraception, such as the pill, patch, injection, or implant
        • Intrauterine device (IUD), a small device placed in the uterus
        • Intrauterine hormone-releasing system, a device placed in the uterus that releases hormone
        • Bilateral tubal occlusion, meaning both fallopian tubes have been blocked or closed
        • A partner who has had a vasectomy, meaning a procedure that prevents sperm from being released
        • Condom, diaphragm, or cervical cap
        • Sexual abstinence, meaning no sexual activity
        • Be willing to follow all study procedures.
        • Be able to understand the study and give informed consent, meaning they agree to take part after receiving and understanding the study information.

Who cannot join the trial?

7 criteria

  • FSH below 25.8 U/L in women who have had no menstrual periods for at least 1 year. FSH means follicle-stimulating hormone, a hormone measured in the blood.
  • A positive urine pregnancy test in women who have had menstrual periods within the last year.
  • Kidney function that is not good enough for treatment as an outpatient, shown by eGFR of 45 mL/min/1.73 m² or lower. eGFR is a test that estimates how well the kidneys filter the blood.
  • Liver blood tests that are too high: ASAT or ALAT at least 3 times the upper normal limit, which means 150 U/L or more for men and 105 U/L or more for women. These are liver enzymes, which are proteins that can rise when the liver is irritated or damaged.
  • Bilirubin at least 1.5 times the upper normal limit, which means 31.5 µmol/L or more. Bilirubin is a substance made when the body breaks down old red blood cells, and a high level can suggest liver or bile duct problems.
  • A known allergy or sensitivity to semaglutide or any of its ingredients.
  • Currently breastfeeding.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Semaglutide

    is the main study medicine. It is given as a shot under the skin and is being tested to help people with overweight who do not have diabetes. In this trial, researchers are looking at whether it is easier to tolerate when used with an extra supportive treatment.

  • Granisetron

    is a supportive medicine taken by mouth. It is used to help prevent or reduce nausea and vomiting, which can be side effects of semaglutide. In this study, it is being given to see if it improves how well people can stay on semaglutide.

What is already known about the treatment

  • Semaglutide

    Semaglutide is given as a subcutaneous injection, which means it is injected under the skin, usually with a small needle. It is a well-known medicine in current medical use and is widely discussed in medical literature for weight loss and for treating type 2 diabetes. It belongs to the class of glucagon-like peptide-1 receptor agonists, and it works by copying a natural hormone that helps the body release insulin, lowers appetite, and slows how fast the stomach empties.

  • Granisetron

    Granisetron is taken by mouth as an oral medicine, usually in tablet form. It is an established medicine in medical practice and is commonly described in medical literature as a treatment for nausea and vomiting. It belongs to the class of serotonin 5-HT3 receptor blockers, and it works by blocking signals in the brain and gut that can trigger nausea, which is why it is often used to help prevent stomach upset.

  • Rice flour

    Rice flour is given by mouth as a placebo, meaning it has no active medicine and is used to compare results in the trial. It is not a treatment in medical practice and has no therapeutic role in the medical literature beyond serving as an inactive control substance. Because it does not contain a drug, it has no pharmacological class and does not work through a medicine-like mechanism.

Investigated diseases

Overweight and obesity - Overweight and obesity are conditions in which a person has more body fat than is considered healthy for their height. They usually develop gradually when energy intake is higher than energy use over time, leading to increasing body weight. The condition may begin as mild excess weight and progress to more marked obesity if weight gain continues. It can remain stable, improve, or worsen depending on long-term changes in body weight and lifestyle.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524612-11-00Protocol codeSEMTOL 1.0Estimated enrolment100 patientsSponsorUniversity Of Tartu

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.