The Effects of Semaglutide vs Testosterone Replacement Therapy on Functional Hypogonadism and Sperm Quality in Men With Type 2 Diabetes Mellitus and Obesity

What Was Tested

The trial (phase 3) is built around Semaglutide.

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.

It had two arms (groups): Semaglutide Treatment (experimental) and Testosterone Replacement Therapy (active comparator).

The registry classes the interventions as drug.

More on the Plan

The participants also gave sperm samples and completed self-reported hypogonadism symptom evaluation (Ageing male symptoms (AMS) score, International Index of erectile function 15 (IIEF-15)).

Who Took Part

25 actual participants took part.

It was open to men only aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Type 2 diabetes mellitus,. Obesity (body mass index (BMI) higher or equal to 30 kg/m\^2),.

The full record lists 3 inclusion and 19 exclusion criteria; among the exclusions: insulin treatment,; glucagon-like peptide 1 (glp-1) agonist treatment,; sodium-glucose cotransporter-2 (sglt-2) inhibitor treatment,.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

The Semaglutide group and the comparison group ran side by side rather than switching.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2020-09-20 with completion listed for 2023-05-11.

It ran at 1 site in Slovenia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in semen volume from baseline and between the treatment arms (time frame: Baseline and 24 weeks). Change in sperm concentration from baseline and between the treatment arms (time frame: Baseline and 24 weeks). Change in total motility of sperm from baseline and between the treatment arms (time frame: Baseline and 24 weeks).

It also tracked 11 secondary outcomes, for example Change in International index of erectile function 15 (IIEF-15) score from baseline and between the treatment arms, Change in Aging male symptoms (AMS) score from baseline and between the treatment arms, Change in HbA1c from baseline and between the treatment arms, Change in follicle-stimulating hormone (FSH) from baseline and between the treatment arms, Change in luteinizing hormone (LH) from baseline and between the treatment arms and Change in estimated visceral adipose tissue from baseline and between the treatment arms.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 25 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.