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Effect of semaglutide on weight loss and metabolic control in liver transplant candidates with obesity

Verified siteRegistered drugNo placebo
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What is this trial about?

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

Adults who are waiting for a liver transplant and who have obesity often also have other health problems such as arterial hypertension, Type 2 diabetes mellitus and dyslipidaemia. The study uses the medicine semaglutide, which is given as a small injection under the skin. Different dose strengths of the injection are available, and participants will receive the dose that is appropriate for them.

The main goal of the study is to see how well the medication helps with weight loss and improves metabolic control in these patients. Participants will start receiving the weekly injections and will have regular clinic visits where their weight, blood tests, and body composition are checked. Imaging with a scan called CT may be used to look at muscle and fat areas before the transplant.

Throughout the study, doctors will monitor safety by recording any side effects and will keep track of how long each person stays in the hospital after the transplant. The study continues until the participant receives the transplant or stops the medication, and all information is collected to understand the benefits and risks of the treatment.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment

    After joining the study, a baseline visit is scheduled. during this visit weight, height, blood pressure, blood sugar, cholesterol and other laboratory tests are measured. imaging of the abdomen may be done to evaluate liver condition. all information is recorded before the first dose of medication.

  2. Step 2

    Start of semaglutide treatment

    The first injection of semaglutide is given as a subcutaneous (under the skin) dose of 0.25 mg using a pre‑filled pen. the injection is administered once a week.

  3. Step 3

    Dose escalation phase

    After four weeks, the dose is increased to 0.5 mg once weekly.

    Four weeks later, the dose is increased to 1 mg once weekly.

    If tolerated, the dose is increased to 1.7 mg once weekly after another four weeks.

    The final increase to 2.4 mg once weekly is made after an additional four weeks, provided no significant side effects occur.

  4. Step 4

    Regular monitoring visits

    Every four weeks a clinic visit is scheduled. weight, blood pressure, blood sugar (fasting glucose and hba1c), cholesterol and liver function tests are repeated.

    The study team checks for any adverse events and confirms that the injection technique is correct.

  5. Step 5

    Continuation until liver transplant

    Weekly injections of the current dose are continued until the patient undergoes liver transplantation.

    The dose may be maintained at the highest tolerated level, typically 2.4 mg, during this period.

  6. Step 6

    Liver transplant surgery

    The transplant operation is performed according to standard medical practice.

    The study records the date of transplant and any immediate complications, but the medication regimen is managed by the transplant team.

  7. Step 7

    Post‑transplant follow‑up

    For 90 days after the transplant, follow‑up visits are conducted to monitor recovery, complications, and any adverse events related to the study medication.

    Weight, blood pressure, laboratory tests and imaging may be repeated as needed.

    The study ends for the participant after the 90‑day post‑transplant observation period.

Who can join the trial?

5 criteria

  • Age: You must be 18 years old or older.
  • Liver transplant candidate: You must be on the active waiting list for a liver transplant or currently being evaluated for inclusion on that list.
  • Body Mass Index (BMI): Your BMI must be 30 or higher, or at least 27 if you also have at least one other condition such as type 2 diabetes, high blood pressure, or abnormal blood fats. BMI is a number that compares your weight to your height. High blood pressure (also called arterial hypertension) means the force of blood against your artery walls is too high. Dyslipidaemia means you have unhealthy levels of cholesterol or other fats in your blood. HbA1c is a blood test that shows your average blood sugar level over the past 2‑3 months; for diabetes it must be less than 8%.
  • Waiting‑list time: You need to have enough time on the transplant waiting list to finish at least 12 weeks of the study medication before a transplant occurs.
  • Informed consent: You or your legal representative must sign a form agreeing to take part in the study.

Who cannot join the trial?

13 criteria

  • Cannot take the study drug if you have a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer) or multiple endocrine neoplasia type 2 (a hereditary condition that causes tumors), because these are absolute reasons to avoid GLP-1 receptor agonists (the drug class used in the trial).
  • Cannot participate if you have advanced chronic kidney disease, defined as a GFR (a test that measures how well the kidneys filter blood) less than 30 mL/min/1.73 m².
  • Cannot join if you have taken semaglutide (the medication being studied) within the past 6 months.
  • Cannot be in the study if you are currently pregnant or breastfeeding.
  • Cannot be eligible if you are currently in another clinical trial, or have been in one during the last 30 days.
  • Cannot participate if you have CHILD C liver dysfunction, which means very severe liver disease.
  • Cannot join if you have had an upper gastrointestinal haemorrhage (bleeding in the upper digestive tract) caused by oesophageal varices (enlarged veins in the esophagus).
  • Cannot be included if you have type 2 diabetes with an HbA1c level of 8 or higher (a blood test that shows average blood sugar over several months).
  • Cannot take part if you have ever had acute (sudden) or chronic (long‑term) pancreatitis (inflammation of the pancreas).
  • Cannot join if you have documented severe gastroparesis (a condition where the stomach empties very slowly).
  • Cannot be enrolled if you have severe disease‑related malnutrition according to GLIM criteria (a set of guidelines for diagnosing malnutrition) or advanced sarcopenia (significant loss of muscle mass) measured by bioimpedance analysis with an ASMMI (a muscle index) below 5 in women or above 7 in men.
  • Cannot participate if you are planning a multi‑organ transplant (such as a liver‑kidney transplant) or a repeat liver transplant.
  • Cannot be included if you have haemodynamic instability (unstable blood pressure or circulation) or an active, uncontrolled infection.
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Investigated drugs

Semaglutide (Wegovy) is a medication given as a subcutaneous injection that works like a hormone that tells the brain you are full. By reducing appetite and slowing stomach emptying, it helps people eat less and lose weight. In this study, it is being tested in people who are waiting for a liver transplant and have obesity, to see if it can safely produce meaningful weight loss and improve their blood sugar and other metabolic measures before surgery.

What is already known about the treatment

Semaglutide - It is supplied as a clear solution for injection in a pre‑filled pen and is given under the skin (subcutaneous injection). The drug is approved and widely used for weight loss and type 2 diabetes, and many studies have documented its safety and effectiveness. It works by copying a natural hormone that tells the brain to feel full and helps the pancreas release insulin when needed. Semaglutide belongs to the class of GLP‑1 receptor agonists, a type of medication that helps control blood sugar and reduces appetite.

Investigated diseases

  • Arterial hypertension

    A chronic condition in which the force of blood against artery walls is consistently higher than normal. Over time the elevated pressure makes the heart and vessels work harder, leading to gradual changes in their structure.

  • Type 2 diabetes mellitus

    A disorder where the body does not respond effectively to insulin, resulting in higher-than‑normal blood sugar levels. Persistent high sugar can affect many organs and may cause the pancreas to produce more insulin initially.

  • Obesity

    A state of excess body fat that reaches a level that may influence overall health. The amount of fat typically increases gradually and can affect how the body handles energy and movement.

  • Dyslipidaemia

    An abnormal concentration of lipids, such as cholesterol or triglycerides, in the blood. These lipid levels can shift over time and may influence the lining of blood vessels.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526953-32-00Protocol codeIMIB-SML-2026-03Estimated enrolment50 patientsSponsorFundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

sourced from the EU Clinical Trials Register and site verification

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