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Study on Testosterone Undecanoate Effects on Liver Fat in Obese Men with Low Testosterone and Type 2 Diabetes or Prediabetes

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 clinical trial is focused on studying the effects of a treatment for men with certain health conditions. The diseases being studied include type 2 diabetes, prediabetes, hypogonadism (a condition where the body doesn't produce enough testosterone), and obesity. The treatment being tested is called testosterone undecanoate, which is given as an injection. The study will compare the effects of this treatment with a placebo to see how it affects liver fat content in men who are obese and have low testosterone levels.

The purpose of the study is to understand how testosterone undecanoate affects liver fat and other health factors in men with these conditions. Participants will receive either the testosterone treatment or a placebo for 52 weeks. After this period, all participants will have the opportunity to receive the testosterone treatment for an additional 108 weeks. This will help researchers learn about the long-term effects of the treatment on body fat distribution and heart-related health factors.

Throughout the study, participants will undergo various assessments to monitor changes in their health, including the use of magnetic resonance spectroscopy (MRS) to measure liver fat content. This study aims to provide valuable insights into how testosterone treatment can impact men with type 2 diabetes, prediabetes, and low testosterone levels, potentially leading to better management of these conditions in the future.

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
Initial phase
Upon joining the study, the participant will be randomly assigned to receive either the testosterone undecanoate injection or a placebo. This phase lasts for 52 weeks.
The medication is administered as an intramuscular injection, which means it is injected directly into a muscle. The dosage is 1000 mg of testosterone undecanoate in a 4 ml solution.
Step 2
Treatment administration
The injections are given at regular intervals as determined by the study protocol. The frequency and exact schedule will be communicated to the participant by the study team.
Participants are required to maintain their current diet and physical activity levels throughout the study period.
Step 3
Monitoring and assessment
Throughout the 52-week period, the participant's liver fat content will be monitored using a technique called magnetic resonance spectroscopy (MRS). This is a non-invasive imaging method used to measure changes in liver fat.
Regular assessments will be conducted to monitor the participant's health and any changes in their condition.
Step 4
Open label phase
After the initial 52 weeks, all participants will enter a 108-week open label phase. During this phase, all participants will receive the testosterone undecanoate treatment.
The focus of this phase is to investigate the long-term effects of the treatment on lipid distribution and cardiometabolic parameters.
Step 5
Final evaluation
At the end of the study, a final evaluation will be conducted to assess the overall effects of the treatment on the participant's health.
The study is expected to conclude by December 31, 2026.

Who can join the trial?

14 criteria

Must be a man.
Must have either **type 2 diabetes** (a condition where the body doesn't use insulin properly) or **prediabetes** (a condition where blood sugar levels are higher than normal but not high enough to be classified as diabetes).
Must have an **HbA1c** level between 5.7% and 9.0%. HbA1c is a blood test that shows average blood sugar levels over the past 2 to 3 months.
Must have a **fasting glucose** level of 100 mg/dl or higher. Fasting glucose is the blood sugar level after not eating for at least 8 hours.
Must have a **postprandial glucose** level of 140 mg/dl or higher. Postprandial glucose is the blood sugar level after eating.
Must be between 18 and 75 years old.
Must have a **BMI** of 25 kg/m² or higher. BMI, or Body Mass Index, is a measure of body fat based on height and weight.
Must have **hypogonadism**, which means having low testosterone levels confirmed by two separate blood tests.
Must be on a stable dose of **Metformin** for at least 8 weeks. Metformin is a medication used to control blood sugar levels.
Must be on a stable dose of **SGLT2 inhibitors** for at least 3 months. SGLT2 inhibitors are medications that help lower blood sugar.
Must be on a stable dose of **DPP4 inhibitors** or **GLP1 agonists** for at least 3 months. These are medications that help control blood sugar levels.
Must be on a stable dose of **long-acting insulin** (also known as basal insulin) for at least 8 weeks. Long-acting insulin helps control blood sugar levels throughout the day.
Must be able and willing to keep the same diet and physical activity level during the study.
Must be able to understand and agree to participate in the study by giving informed consent.

Who cannot join the trial?

5 criteria

Women cannot participate in the study. Only men are eligible.
Individuals who do not have low levels of the hormone testosterone (a condition known as hypogonadism) cannot participate.
Individuals who do not have type 2 diabetes or prediabetes cannot participate. Type 2 diabetes is a condition where the body does not use insulin properly, and prediabetes is when blood sugar levels are higher than normal but not high enough to be classified as diabetes.
Individuals who are not overweight or obese cannot participate. Being overweight or obese means having more body weight than is considered healthy for a certain height.
Individuals who are part of a vulnerable population, such as those who cannot give informed consent, are not eligible to participate.

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Verified sites

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Medical University Of Vienna
Vienna, Austria

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Investigated drugs

Testosterone Undecanoate is a form of testosterone given as an injection. In this clinical trial, it is used to see if it can help reduce liver fat in obese men who have type 2 diabetes and low testosterone levels. The study aims to understand if this treatment can improve the distribution of fat in the body and other health markers related to heart and metabolism over a long period.

Testosterone Undecanoate

What is already known about the treatment

Testosterone Undecanoate – This medication is administered through intramuscular injection. It is currently being studied in clinical trials to assess its effects on intrahepatic fat content in obese men with uncontrolled type 2 diabetes and hypogonadism. The main therapeutic indications include treatment for hypogonadism, type 2 diabetes, prediabetes, overweight, and obesity. At the molecular level, testosterone undecanoate works by supplementing testosterone levels, which can influence fat distribution and improve metabolic parameters. It is classified as an androgen and anabolic steroid.

Investigated diseases

Hypogonadism
This condition occurs when the body produces insufficient sex hormones, which can affect growth, development, and reproductive functions. In men, it may lead to reduced muscle mass, decreased libido, and infertility. It can be caused by problems with the testicles or the pituitary gland. Symptoms may include fatigue, depression, and reduced body hair. The condition can be present from birth or develop later in life.
Type 2 Diabetes Mellitus (T2DM)
This chronic condition affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body's cells do not respond properly to insulin. Over time, high blood sugar levels can lead to serious health issues. Common symptoms include increased thirst, frequent urination, and fatigue. It often develops in adults but can occur at any age.
Prediabetes
This condition is marked by higher-than-normal blood sugar levels, but not high enough to be classified as type 2 diabetes. It indicates an increased risk of developing type 2 diabetes and other health problems. Often, there are no clear symptoms, making it difficult to detect without blood tests. Lifestyle changes can help manage blood sugar levels. It is a critical stage for intervention to prevent progression to diabetes.
Overweight
This condition is defined by having more body weight than is considered healthy for a given height. It is often measured using the Body Mass Index (BMI). Being overweight can increase the risk of various health issues, including heart disease and diabetes. It can result from a combination of factors, including diet, physical activity, and genetics. Managing weight involves balancing calorie intake with physical activity.
Obesity
This condition is characterized by excessive body fat that may impair health. It is typically measured using the Body Mass Index (BMI), with a BMI of 30 or higher indicating obesity. Obesity can lead to numerous health problems, such as heart disease, diabetes, and joint issues. It is often caused by a combination of genetic, behavioral, and environmental factors. Addressing obesity involves lifestyle changes, including diet and exercise.