Authorised Therapeutic use (Phase IV) hypogonadism, T2DM, prediabetes, overweight, obesity

Studying the effects of intramuscular testosterone supplementation compared with placebo on liver fat content in obese men with low testosterone levels and type 2 diabetes (T2DM) or prediabetes followed by a subsequent open label phase to investigate metabolic long term effects.

EU CTIS ID: 2023-509819-87-00

What this study is testing

to identify the effects of testosterone supplementation in hypogonadal men suffering from type 2 diabetes or prediabetes on intrahepatic fat content assessed as change from baseline to follow up

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • T2DM or prediabetes, 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: two measurements below lower limit of normal total testosterone levels (< 4,04ng/ml (=14nmol/l) according to guideline Wittert et al. Lancet Diabetes Endocrinol. 2021), Metformin >=8 weeks stable dose, SGLT2 inhibitors >=3 months stable dose, DPP4 inhibitors or GLP1 agonist >= 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 enrolement in study, consent and able to give informed consent.

You likely can't join if

  • • Current testosterone treatment or testosterone replacement within the last 12 month • Serum creatinine>1,5mg/dl • Liver enzymes above 3 fold normal range • PSA>4.0µg/l • Hematocrit>50% • Known intolerance to testosterone undecanoate or any of its ingredients • 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 • Migraine • 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. • patients on antidiabetic medication like Sulfonylurea or Glitazones. • 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 • 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 • History of bariatric surgery • 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. • Any subject who is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff thereof, directly involved in the conduct of the protocol. • Contraindication for intramuscular injection (e.g patient receiving anticoagulants on a regular basis such as NOAKs or VKAs, or DAPT). • COPD Gold IV or recurrent acute or allergic asthma (for MPI)

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.