RecruitingRare disease

Study on the Effects of Pegvisomant and Somatropin on Liver Fat Metabolism in Patients with Acromegaly and Healthy Individuals

Verified siteRegistered drugNo placebo

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 focused on studying the effects of growth hormone on liver fat metabolism in humans. The study involves two groups of participants: those with acromegaly, a condition where the body produces too much growth hormone, and healthy individuals. The treatment being tested includes two medications: SOMAVERT, which contains the active substance pegvisomant, and Genotropin, which contains somatropin. Both medications are administered as a solution for injection under the skin.

The purpose of the study is to understand how growth hormone affects the liver's ability to process fats and energy. Participants will receive either the medication or a placebo, and the study will observe changes in the body's energy use, liver fat content, and the production of certain types of fat in the liver. The study will also look at how these changes affect overall body composition and energy expenditure.

Participants will be involved in the study for a short period, during which they will receive injections and undergo various assessments to monitor the effects of the treatment. The study aims to provide insights into how growth hormone influences liver function and fat metabolism, which could have implications for treating conditions related to growth hormone levels.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants will be informed about the purpose and procedures involved. The study aims to understand the role of growth hormone in liver fat metabolism in humans.
Step 2
Initial assessment
Participants will undergo an initial assessment to confirm eligibility. This includes checking age, which should be between 18 and 70 years, and for healthy volunteers, ensuring plasma triglycerides are less than 300 mg/dl and that they are male.
Step 3
Medication administration
Participants will receive medications through subcutaneous injection. The medications used are pegvisomant and somatropin. The specific dosage, frequency, and duration of administration will be explained during the study.
Step 4
Monitoring and follow-up
Throughout the study, participants will be monitored for changes in energy metabolism, liver fat content, and other related factors. This includes observing changes in VLDL secretion and de novo lipogenesis, which is the body's process of creating fat from other substances.
Step 5
Completion of the study
The study is expected to end by January 3, 2025. Participants will be informed about the outcomes related to the role of growth hormone in liver fat metabolism.

Who can join the trial?

3 criteria

Age between 18 and 70 years
For healthy volunteers: Plasma triglycerides (a type of fat found in your blood) must be less than 300 mg/dl
For healthy volunteers: Must be male

Who cannot join the trial?

5 criteria

People with a condition called acromegaly cannot participate. This is a condition where the body produces too much growth hormone, leading to enlarged bones and tissues.
Only healthy individuals can participate. This means you should not have any ongoing medical conditions.
Participants must be within a certain age range. If you are too young or too old, you may not be eligible.
Both men and women can participate, but certain health conditions specific to gender may exclude you.
Individuals who are considered part of a vulnerable population are not eligible. This includes groups who may need special protection or care.

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

Medical University Of Vienna
Verified
Vienna, Austria

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

Growth Hormone (GH) is a natural substance produced by the body that helps with growth and development. In this clinical trial, it is being studied to understand how it affects the way the liver processes fats. Researchers are interested in seeing if GH can change how the liver releases certain types of fat into the blood and how it influences the body's energy use. This could help us learn more about how GH affects liver health and fat metabolism in healthy people.

What is already known about the treatment

Growth Hormone – Growth hormone is typically administered through an injection under the skin. It is currently being studied for its effects on liver fat metabolism in both healthy individuals and those with acromegaly, a condition characterized by excessive growth hormone production. The main therapeutic use of growth hormone is to help regulate growth and metabolism. At the molecular level, it works by binding to specific receptors on cells, which triggers a series of reactions that promote growth and influence how the body uses energy. Growth hormone is classified as a peptide hormone, which means it is made up of amino acids and acts as a signaling molecule in the body.

Investigated diseases

Acromegaly – Acromegaly is a hormonal disorder that develops when the pituitary gland produces excess growth hormone. This overproduction typically occurs in middle-aged adults. The condition leads to the enlargement of bones and tissues, most noticeably in the hands, feet, and face. Over time, individuals may experience joint pain, thickened skin, and enlarged organs. The progression is usually slow, making early changes hard to detect. If left unchecked, it can lead to complications affecting various body systems.