Taking peoplePhase 4

Tests testosterone undecanoate in men with fatty liver, diabetes risk and low testosterone

Tests testosterone undecanoate against placebo in overweight men with prediabetes or diabetes.

Plain-language title generated from the registry record
Registry title: Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism

Key facts

Where: Vienna, AustriaSee the site
Phase: Phase 4

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men aged 18 to 75 with prediabetes or type 2 diabetes, overweight or obesity, and low testosterone. It tests testosterone undecanoate against placebo for fat in the liver.

Age: 18 to 75 years
Sex: Men only
Disease stage: Prediabetes or type 2 diabetes (HbA1c 5.7% (39 mmol/mol) to 9.0% (75 mmol/mol), or fasting glucose of 100mg/dl (5.6 mmol/L) or more, or glucose after a meal of 140mg/dl (7.8 mmol/L) or more), BMI of 25kg/m² or more, and low testosterone (below 4,04ng/ml, which is 14nmol/l).
Earlier treatment: Must be on a stable dose of diabetes medicines: metformin 8 weeks, SGLT2 inhibitors 3 months, DPP4 inhibitors 3 months, GLP1 RA 3 months, long acting (basal) insulin 8 weeks. Must not have had testosterone treatment in the last 12 months.
Biomarker or test result: Testosterone below 4,04ng/ml (14nmol/l) in a lab test.

Main reasons for not taking part

Prostate cancer or any suspicion of it, or PSA above 4.0μg/l
Heart attack or stroke in the last 12 months
Other liver disease, including viral hepatitis, alcohol abuse or cirrhosis
Taking sulfonylurea or glitazone diabetes medicines
Anything that makes an MRI unsafe, such as a pacemaker or insulin pump

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 75 years old?

Source: NCT03851627, who can take part

Where in Austria

Medical University of ViennaVienna, AustriaNo longer taking part

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it: Alexandra Kautzky-Willer
Trial code: NCT03851627 EU 2023-509819-87-00
Record updated: 13 March 2024
Original description: The epidemics of obesity, MeTSy, T2DM and CVD are increasing worldwide. Non-alcoholic fatty liver disease (NAFLD) is becoming recognized as a condition possibly involved in the pathogenesis of these diseases. The prevailing hypothesis for NAFLD pathogenesis is the 'two-hit' model, with insulin resistance and hyperinsulinemia playing essential roles, which have a plethora of effects on hepatic lipid metabolism and can lead to accumulation of triglycerides in hepatocytes. Accepted treatment for NAFLD is lifestyle modifications. Sex hormones might be relevant in T2DM development and treatment. Low testosterone (T) has deteriorating effects on glucose levels, and aggravates in obesity as aromatization of T is enhanced. T deficiency is related to increases of visceral fat accumulation and associated with development of NAFLD. T replacement might be a successful way in hypogonadism to treat obesity and counteract progression of MEtSy,T2DM or CVD driven by visceral fat accumulation or NAFLD.Read full original descriptionShow less
52 Week RCT to Investigate the Effect of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Obese/Overweight Men With T2DM/Prediabetes and Hypogonadism and Subsequent 108 Week Open Label Phase to Investigate Effects on Cardiometabolic Parameters
The epidemics of obesity, MeTSy, T2DM and CVD are increasing worldwide. Non-alcoholic fatty liver disease (NAFLD) is becoming recognized as a condition possibly involved in the pathogenesis of these diseases. The prevailing hypothesis for NAFLD pathogenesis is the 'two-hit' model, with insulin resistance and hyperinsulinemia playing essential roles, which have a plethora of effects on hepatic lipid metabolism and can lead to accumulation of triglycerides in hepatocytes. Accepted treatment for NAFLD is lifestyle modifications. Sex hormones might be relevant in T2DM development and treatment. Low testosterone (T) has deteriorating effects on glucose levels, and aggravates in obesity as aromatization of T is enhanced. T deficiency is related to increases of visceral fat accumulation and associated with development of NAFLD. T replacement might be a successful way in hypogonadism to treat obesity and counteract progression of MEtSy,T2DM or CVD driven by visceral fat accumulation or NAFLD.
Primary Objective To investigate the effects on hepatic lipid content reduction of a therapy with Testosterone undecanoate 1000mg compared to placebo given for 52 weeks in patients with type 2 diabetes mellitus and hypogonadism.
Inclusion: prediabetes/T2DM; male sex; HbA1c >=5.7% -9.0% or fasting glucose >=100mg/dl or postprandial glucose>= 140mg/dl; Age >=18 -75 years; BMI>=25kg/m²; Hypogonadism assessed by laboratory testing (testosterone < 4,04ng/ml (=14nmol/l) Metformin 8 weeks stable dose, SGLT2 inhibitors 3 months stable dose, DPP4 inhibitors 3 months stable dose, GLP1 RA 3 months stable dose and long acting insulin (basal insulin) 8 weeks stable dose; able and willing to not change diet and physical activity during enrollment in study; consent and able to give informed consent.
Exclusion: patients on antidiabetic medication like Sulfonylurea or Glitazones; Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake; Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight; Subjects receiving antihypertensive medication and/or thyroid hormones, the dose(s) of which have not been stable for at least 6 weeks prior to baseline; Current treatment with systemic steroids at time of informed consent. (Treatment with local and inhaled steroids is allowed); Donation of blood (> 400 mL) during the previous 3 months prior to the screening visit or during the duration of the study; Participation in another trial with an investigational drug within 30 days prior to informed consent; contraindication for intramuscular injection (e.g patient receiving anticoagulants on a regular basis such as NOAKs or VKAs, or DAPT); Myocardial infarction within the last 12month; Stroke within the last 12 month; Untreated congestive heart disease; malignancy within the last 5 years before randomization; Prostate cancer or any suspicion thereof; Breast cancer; Liver tumor/cancer; Epilepsy; Presence of any absolute or relative contraindication for the conduct of an MRI investigation, such as cardiac pacemakers, ferromagnetic haemostatic clips in the central nervous system, metallic splinters in the eye, ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators, cochlear implants, insulin pumps and nerve stimulators, prosthetic heart valves etc; Any other clinical condition that would jeopardize patients safety while participating in this clinical trial; Known autoimmune disease or chronic inflammatory condition; Other liver disease including chronic viral hepatitis (B or C), alcohol abuse, hemochromatosis, alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's disease, primary sclerosing cholangitis or primary biliary cirrhosis, or liver cirrhosis of any etiology; History of bariatric surgery; Uncontrolled/ untreated hypertension; COPD Gold IV or recurrent acute or allergic asthma (for MPI); Contraindications for cardiac stress test as acute myocardial infarction, instable angina, severe hypertension, myocarditis, life threatening rhythmic disorders without physical activity; Serum creatinine>1,5mg/dl; PSA>4.0μg/l; Current testosterone treatment or testosterone replacement within the last 12 month; Liver enzymes above 3 fold normal range; Hematocrit>50%; Known intolerance to testosterone undecanoate or any of its ingredients; Migraine; Pharmacist, study coordinator, other staff thereof, directly involved in the conduct of the protocol.
ClinicalTrials.gov NCT03851627 · EU CTIS 2023-509819-87-00