Herlev Hospital
Herlev, Denmark
Not yet recruiting
Effect of Semaglutide and Testosterone Undecanoate on Body Composition in Obese Men with Functional Hypogonadism: A Randomized 52‑Week Trial
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What is this trial about?
A plain-language summary of the goals, design and what participants do
Functional hypogonadism is a condition in which men have low levels of testosterone and related symptoms, often linked to excess body weight. When obesity contributes to this hormonal imbalance, men may experience reduced muscle strength, decreased energy, and changes in sexual health.
The study evaluates the effects of two medicines: a weekly subcutaneous injection of Semaglutide at a dose of 2.4 mg, which is known to aid weight loss and improve metabolic health, and an intramuscular injection of testosterone undecanoate given at 1,000 mg every 13 weeks to replace the missing hormone. Participants are randomly assigned to receive either one of the medicines alone, the combination of both, or a placebo, and the trial lasts for 52 weeks with regular clinic visits for safety checks and assessments.
The purpose of the trial is to determine whether the combined treatment can better preserve the proportion of fat‑free (muscle) mass compared with the placebo. Throughout the year‑long study, body composition is measured using a scan called DXA, which provides a picture of bone, muscle, and fat levels, and hormone levels and other health indicators are checked to see how the treatments affect overall well‑being.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- Give written permission (called informed consent) after you understand the study, before any study procedures are done.
- Be a man who is between 20 and 75 years old when you sign the consent.
- Have low sex‑hormone levels (called hypogonadism) shown by a blood test that measures total testosterone (the main male hormone) at 2.6 to 10.4 nmol per liter (a unit of concentration) taken before 10 am, and also have symptoms such as low energy or reduced muscle strength.
- Have a blood level of luteinizing hormone (called LH) that is 6 IU per liter or lower (IU means international units, a way to measure hormone amount).
- Have a body‑mass index (called BMI) between 30 and 50 kg/m², which indicates obesity.
Who cannot join the trial?
28 criteria
- You must not have type 1 diabetes, a disease where the body cannot produce insulin.
- You cannot join if you have any health problem that the doctor thinks could make the study unsafe or make it hard for you to follow the study rules.
- You are excluded if your obesity is caused by an endocrine (hormone) disorder such as Cushing’s syndrome, except if you only have type 2 diabetes.
- You must not have donated more than 400 ml of blood or plasma in the 90 days before screening.
- You cannot be taking prescription or over‑the‑counter medicines (other than routine vitamins, occasional acetaminophen, aspirin, or ibuprofen) that could affect how the study drug works, such as herbal products, insulin, weight‑gain drugs (e.g., systemic steroids, certain antidepressants, antipsychotics), weight‑loss drugs (e.g., orlistat, bupropion), or any other medication that the doctor believes could interfere.
- You must not have a history of pancreatitis (inflammation of the pancreas), whether acute or chronic.
- You cannot participate if your blood test shows a PSA (prostate‑specific antigen) level higher than 4 ng/ml, which can indicate prostate issues.
- You are excluded if your hematocrit (the proportion of red blood cells in your blood) is higher than 48 %.
- You must not have untreated severe obstructive sleep apnea, a condition where breathing stops repeatedly during sleep.
- You cannot join if you have severe urinary problems caused by an enlarged prostate (prostatic hyperplasia).
- You are excluded if you have uncontrolled heart failure, defined as a heart‑pumping ability (ejection fraction) less than 30 % or less than 40 % with a hospital admission for heart failure in the past year.
- You must not plan to become a father within the next two years.
- You cannot take part if you have had a heart attack (myocardial infarction) or stroke in the last six months.
- You are excluded if you have thrombophilia, a tendency for abnormal blood clotting.
- You cannot be using morphine every day.
- You must not have a severe depressive disorder, schizophrenia, bipolar disorder, or any serious psychiatric condition within the past two years, or a lifetime history of a suicide attempt.
- You cannot be scheduled for any surgery during the study period, except for minor, non‑gastrointestinal procedures that the doctor approves.
- You are excluded if you have had cancer (past or present) that could affect the study results, except for basal cell or squamous cell skin cancer.
- You must be able and willing to give yourself an injection during the screening visit; inability to do so excludes you.
- You cannot join if you have mental incapacity, language barriers, or are unwilling to follow the study requirements.
- Study staff, their families, or anyone directly involved in running the trial cannot be participants.
- You are excluded if your kidney function is low, measured as an estimated glomerular filtration rate (GFR) below 45 ml/min/1.73 m².
- You must not be known or suspected to be allergic (hypersensitivity) to the study medication or related products.
- You cannot participate if you have had a sudden worsening of blood‑sugar control that required urgent treatment for complications such as diabetic ketoacidosis within 90 days before screening.
- You are excluded if you are using more than three oral diabetes medicines for type 2 diabetes.
- You cannot join if you have already taken part in this trial before, as indicated by a signed consent form.
- You must not have been in another clinical trial in the 90 days before screening.
- You are excluded if you have used a GLP‑1 receptor agonist (a type of diabetes medication) within the past six months.
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Investigated drugs
Semaglutide is a medication given as a subcutaneous (under‑the‑skin) injection once a week. It works by mimicking a natural hormone that reduces appetite and helps the body use food better, which can lead to weight loss and improve blood sugar control. In this trial it is being tested to see if it can help men with obesity and low testosterone keep more of their lean (fat‑free) body mass.
Testosterone undecanoate is a long‑acting form of testosterone that is injected into a muscle about every 13 weeks. It replaces the hormone that men with low testosterone are missing, which can improve energy levels, sexual function, mood, and increase muscle mass. The trial is evaluating whether this treatment can improve body composition and symptoms of low testosterone in obese men.
The combination therapy uses both Semaglutide and Testosterone undecanoate together—weekly semaglutide injections plus the testosterone injection every 13 weeks. The goal is to see if using the two medicines together provides greater benefits for preserving lean body mass and reducing symptoms of low testosterone compared with each treatment alone.
What is already known about the treatment
Semaglutide
This medication is given as a subcutaneous injection once a week using a pre‑filled syringe. It is an approved drug used for weight management and type 2 diabetes, and many studies have been published about it. Semaglutide works by copying a natural hormone that tells the body to release insulin and to feel full, which helps lower blood sugar and reduce appetite. It belongs to the drug class called glucagon‑like peptide‑1 (GLP‑1) receptor agonists.
Testosterone undecanoate
This drug is injected into a muscle (intramuscular) every 13 weeks as a clear solution. It is an approved long‑acting testosterone replacement for men with low testosterone levels and is well documented in medical literature. The medication provides testosterone, which binds to receptors in the body to support muscle growth, bone strength, and overall energy. It is classified as an androgen (an anabolic steroid).
Investigated diseases
Functional hypogonadism - Functional hypogonadism is a condition where the testes produce insufficient testosterone because of impaired signaling from the brain rather than damage to the testes themselves. It often develops gradually in men who are overweight or have metabolic disturbances. Symptoms may include reduced muscle mass, low energy, and decreased sexual desire. Over time, the low hormone levels can lead to further loss of lean body tissue and changes in bone density. The condition can persist or worsen if the underlying hormonal imbalance is not addressed.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-527373-11-00Estimated enrolment248 patientsSponsorRegion Hovedstaden
sourced from the EU Clinical Trials Register and site verification
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