Trial · Interventional
CompletedPhase 3Registry dataShort name SEMAT
Slovenia
1 trial · 1 completed
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The goal of this study is to learn whether semaglutide (treatment for type 2 diabetes and obesity) can improve signs and symptoms of hypogonadism in men with type 2 diabetes, obesity and hypogonadism (a condition when levels of testosterone are decreased). The main questions the study aims to answer are: * Does semaglutide improve the quality of sperm? * Does semaglutide improve symptoms of hypogonadism as well as testosterone replacement? The researchers will compare semaglutide to testosterone replacement to see which drug better treats symptoms of hypogonadism. * The participants will receive testosterone replacement therapy (intramuscular injection every 10-12 weeks) or magnitude (subcutaneous injection once a week). * The treatment will last 24 weeks. * The participants will visit the clinic at the start and the end of the study. At the visit, the researchers will measure body weight and take a few blood samples. The participants will also be asked to complete several questionnaires and collect a sperm sample. The participants are free to terminate their participation in the study at any time without giving a reason.
Experimental
Semaglutide Treatment
Active comparator
Testosterone Replacement Therapy
Outcomes the sponsor listed as primary.
Change in semen volume from baseline and between the treatment arms
Time frame · Baseline and 24 weeks
The semen volume will be measured and reported in mililiters (mL). The higher the value the better the outcome.
Change in sperm concentration from baseline and between the treatment arms
Time frame · Baseline and 24 weeks
The sperm concentration will be measured and reported in number times 10\^6 per mililiter (10\^6/mL). The higher the value the better the outcome.
Change in total motility of sperm from baseline and between the treatment arms
Time frame · Baseline and 24 weeks
The total motility will be assessed as total number of motile sperm and reported as number times 10\^6 per ejaculate (10\^6/ejaculate). The higher the value the better the outcome.
Change in normal sperm forms from baseline and between the treatment arms
Time frame · Baseline and 24 weeks
The normal sperm forms will be assessed as total number of sperm with normal morphology and reported as number times 10\^6 per ejaculate (10\^6/ejaculate). The higher the value the better the outcome.
Change in total number of sperm from baseline and between the treatment arms
Time frame · Baseline and 24 weeks
The total number of sperm will be measured and reported in number times 10\^6 per ejaculate (10\^6/ejaculate). The higher the value the better the outcome.
Change in International index of erectile function 15 (IIEF-15) score from baseline and between the treatment arms
Time frame · Baseline and 24 weeks
IIEF-15 assesses male sexual function. It has 5 domains. Erectile function with scoring range from 30 (max) to 1 (min). Orgasmic function with scoring range from 10 (max) to 1 (min). Sexual desire with scoring range from 10 (max) to 2 (min). Intercourse satisfaction with scoring range from 15 (max) to 0 (min). Overall satisfaction with scoring range from 10 (max) to 2 (min). The subdomains combine to overall score with scoring range from 75 (max) to 6 (min). The higher score indicates the better sexual function.
Change in Aging male symptoms (AMS) score from baseline and between the treatment arms
Time frame · Baseline and 24 weeks
The AMS score assesses male symptoms os hypogonadism. It has 3 subdomains. Psychological symptoms with scoring range from 25 (max) to 5 (min). Somatic with scoring range from 35 (max) to 7 (min). Sexual with scoring range from 25 (max) to 5 (min). The subdomains combine to overall score with scoring range from 85 (max) to 17 (min). The lower the score the less symptoms are present.
Change in HbA1c from baseline and between the treatment arms
Time frame · Baseline and 24 weeks
The HbA1c will be measured and reported in % and milimoles per mole (mmol/mol). The lower the value the better the outcome.
Change in follicle-stimulating hormone (FSH) from baseline and between the treatment arms
Time frame · Baseline and 24 weeks
The FSH will be measured and reported in international units per liter (IU/L). The higher the value the better the outcome.
Change in luteinizing hormone (LH) from baseline and between the treatment arms
Time frame · Baseline and 24 weeks
The LH will be measured and reported in international units per liter (IU/L). The higher the value the better the outcome.
Change in estimated visceral adipose tissue from baseline and between the treatment arms
Time frame · Baseline and 24 weeks
Measured by dual-energy X-ray absorptiometry the estimated visceral adipose tissue will be reported in grams (g). The lower the value the better the outcome.
Change in percentage of body fat from baseline and between the treatment arms
Time frame · Baseline and 24 weeks
Measured by dual-energy X-ray absorptiometry the procentage of body fat will be reported in %. The lower the value the better the outcome.
Change in fasting serum low-density lipoproteins (LDL) cholesterol from baseline and between the treatment arms
Time frame · Baseline and 24 weeks
The LDL cholesterol will be measured and reported in milimoles per liter (mmol/L). The lower the value the better the outcome.
Change in fasting serum total cholesterol from baseline and between the treatment arms
Time frame · Baseline and 24 weeks
The total cholesterol will be measured and reported in milimoles per liter (mmol/L). The lower the value the better the outcome.
Change in fasting serum high-density lipoproteins (HDL) cholesterol from baseline and between the treatment arms
Time frame · Baseline and 24 weeks
The HDL cholesterol will be measured and reported in milimoles per liter (mmol/L). The higher the value the better the outcome.
Change in fasting triglycerides from baseline and between the treatment arms
Time frame · Baseline and 24 weeks
Triglycerides will be measured and reported in milimoles per liter (mmol/L). The lower the value the better the outcome.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2025
Gregorič et al. 2025Diabetes, obesity & metabolismcited by 33
PMID 39511836PMC11701185DOI 10.1111/dom.16042PUB-39511836
Who could join, as posted.
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