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Study of the effectiveness and safety of tirzepatide for treating obesity in patients waiting for a liver transplant

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

This study aims to evaluate the efficacy and safety of a medication for treating Obesity in people waiting for a liver transplant, which is a surgical procedure to replace a diseased liver with a healthy one. The medication being studied is tirzepatide, which is administered via subcutaneous injection, meaning the medicine is injected into the fatty layer of tissue just beneath the skin. Participants may receive different doses of the drug, such as 2.5 mg or 5 mg, to determine how well it works.

The focus of the research is to observe changes in body weight, Body Mass Index (a measure of body fat based on height and weight), and body fat composition. The study also monitors for any potential complications related to the original liver disease or the treatment itself. Additionally, the research tracks how patients fare after their transplant, looking at survival rates and the health of the new organ during the months following the surgery.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Medication administration
The treatment involves the use of mounjaro, which is a medication used to help manage weight. this is administered as a subcutaneous injection, which means the medicine is injected into the fatty layer of skin just under the skin.
The dosage starts with 2.5 mg of tirzepatide (the active substance in the medication) using a pre-filled pen. subsequently, the dosage is adjusted to 5 mg of tirzepatide using a pre-filled pen.
Step 2
Monitoring and follow-up
During the study, changes in body weight, body mass index (a measure of body fat based on height and weight), and body fat composition are monitored.
The safety of the treatment is observed by tracking any adverse events, which are side effects or unintended medical occurrences.
If a liver transplant occurs, medical observations continue at 1 month, 3 months, and 6 months after the procedure to monitor health and the survival of the new organ.

Who can join the trial?

7 criteria

You must be at least 18 years old.
You must be a candidate for a liver transplant (a surgery to replace a damaged liver with a healthy one) and currently undergoing medical checks, whether as an inpatient in a hospital or as an outpatient visiting the clinic.
Your BMI (Body Mass Index, a measure used to determine if a person is at a healthy weight for their height) must be 30 or higher.
If you have significant fluid retention (extra fluid building up in your body, such as edema in your legs, ascites in your abdomen, or hydrothorax around your lungs), your BMI must be 33 or higher.
For people with large amounts of fluid in the abdomen or around the lungs, your BMI will be measured after the fluid is removed through a procedure called evacuation puncture.
You must be clinically stable, meaning you are either living at home under regular doctor supervision or staying in a standard hospital room without showing signs of getting much worse or having serious medical complications.
You must provide a signed informed consent (a written document showing you understand the study and agree to participate).

Who cannot join the trial?

12 criteria

Having hepatic encephalopathy, which is a brain problem caused by liver disease that prevents the liver from removing toxins from the blood.
Having refractory ascites (constant buildup of fluid in the belly) or hydrothorax (fluid buildup around the lungs) that requires two or more drainage procedures in the last two months.
Needing a combined liver-kidney transplantation, which means needing both a liver and a kidney transplant at the same time.
Being pregnant or being a woman of childbearing age who is not using highly effective contraception (birth control methods like hormones or barriers that have a failure rate of less than 1% per year).
Having a history of pancreatitis, which is inflammation or swelling of the pancreas, either suddenly (acute) or over a long period (chronic).
Having polycystic liver disease, a condition where many fluid-filled sacs called cysts grow in the liver.
Having Type 1 diabetes mellitus, a condition where the body does not produce enough insulin to manage blood sugar.
Having liver malignancy (liver cancer) that does not meet specific medical guidelines, such as Klatskin tumors, cancer that spread from the colon, or NET metastases (cancer that spread from neuroendocrine tumors).
Having an unstable clinical condition, meaning your health is not steady, or being admitted to the hospital unexpectedly because your health has gotten much worse.
Experiencing spontaneous weight loss of 5% or more in the last six months that was not caused by using diuretics (water pills) or fluid drainage procedures.
Having sarcopenia, which is a loss of muscle mass and strength, as seen on a special body scan called a CT scan.
Being unable to perform physical activity, such as walking for 30 minutes every day.

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Verified sites

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Institute For Clinical And Experimental Medicine
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Prague, Czechia

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Investigated drugs

Tirzepatide is a medication given as an injection under the skin to help treat obesity. It is being studied to see how well it works and how safe it is for people who are waiting for a liver transplant.

Tirzepatide

What is already known about the treatment

Tirzepatide - This medication is given as a solution through a small injection under the skin using a pre-filled pen. It is a currently approved medicine used to help manage blood sugar levels and weight loss. It works by mimicking two natural hormones in the body that signal the brain to feel full and help the pancreas release insulin. This drug belongs to a class of medications known as dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonists.

Investigated diseases

Obesity - This condition occurs when an individual accumulates excessive amounts of body fat. It is often characterized by a high body mass index relative to height. Over time, the accumulation of fat can increase throughout different parts of the body. The condition can progress as energy intake consistently exceeds the energy used by the body. This process leads to a gradual increase in total body weight and body fat composition.