DelfaGLP-1 Atlas

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SEMAT

CompletedPhase 3

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

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

25

actual

Study population

Obesity / overweight, Reproductive / infertility, Type 2 diabetes

Key I/E criterion

•Male

Primary endpoints

•Semen volume from baseline and between the treatment arms•Sperm concentration from baseline and between the treatment arms•Total motility of sperm from baseline and between the treatment arms

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06489457
Org study IDSEMA-TESTO Hypogonadism
Secondary ID0120-26/2020/13Slovenian National Medical Ethics Committee NMEC

Timeline

Milestones

Study start2020-09-20actual
Primary completion2023-05-11actual
Study completion2023-06-30actual
Study first posted2024-07-08actual
Last update posted2024-07-08actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweightReproductive / infertilityType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexMale
Healthy volunteersNot accepted

Inclusion criteria

•type 2 diabetes mellitus,
•obesity (body mass index (BMI) higher or equal to 30 kg/m^2),
•functional hypogonadism (defined by total testosterone less than 11 nmol/L and 2 or more symptoms of sexual dysfunction)

Exclusion criteria

•Insulin treatment,
•glucagon-like peptide 1 (GLP-1) agonist treatment,
•sodium-glucose cotransporter-2 (SGLT-2) inhibitor treatment,
•other identified causes of hypogonadism,
•hemochromatosis,
•active malignant disease,
•thrombophilia,
•venous thrombosis within 6 months,
•recent acute myocardial infarction or stroke,
•prostate-specific antigen (PSA) higher than 3 ng/L,
•severe lower urinary tract symptoms with an International Prostate Symptom Score above 19,
•severe sleep apnea syndrome,
•hematocrit higher than 0.5,
•significant kidney or liver disease,
•ongoing treatment with opioid analgesics, antipsychotics, glucocorticoids,
•alcohol abuse,
•severe ongoing mental illness,
•personal history of pancreatitis or medullary thyroid carcinoma,
•personal or family history of multiple endocrine neoplasia type 2.

Endpoints (19)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
7
Weight & body composition
4
Cardiometabolic biomarkers
4
Glycemic / diabetes
2
Patient-reported / QoL
2

Weight & body composition

4 endpoints
Secondary/protocol endpoint

Change in estimated visceral adipose tissue from baseline and between the treatment arms

Time frame:Baseline and 24 weeks

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Change in percentage of body fat from baseline and between the treatment arms

Time frame:Baseline and 24 weeks

Total fat mass

change from baseline, improvement

Other/protocol endpoint

Change in body mass from baseline and between the treatment arms

Time frame:Baseline and 24 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Other/protocol endpoint

Change in body mass index (BMI) from baseline and between the treatment arms

Time frame:Baseline and 24 weeks

BMI, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change in HbA1c from baseline and between the treatment arms

Time frame:Baseline and 24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Other/protocol endpoint

Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) score from baseline and between the treatment arms

Time frame:Baseline and 24 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Change in fasting serum low-density lipoproteins (LDL) cholesterol from baseline and between the treatment arms

Time frame:Baseline and 24 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in fasting serum total cholesterol from baseline and between the treatment arms

Time frame:Baseline and 24 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in fasting serum high-density lipoproteins (HDL) cholesterol from baseline and between the treatment arms

Time frame:Baseline and 24 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in fasting triglycerides from baseline and between the treatment arms

Time frame:Baseline and 24 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Change in International index of erectile function 15 (IIEF-15) score from baseline and between the treatment arms

Time frame:Baseline and 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Aging male symptoms (AMS) score from baseline and between the treatment arms

Time frame:Baseline and 24 weeks

change from baseline, improvement

Other clinical outcomes

7 endpoints
Primary/protocol endpoint

Change in semen volume from baseline and between the treatment arms

Time frame:Baseline and 24 weeks

change from baseline, improvement

Primary/protocol endpoint

Change in sperm concentration from baseline and between the treatment arms

Time frame:Baseline and 24 weeks

change from baseline, improvement

Primary/protocol endpoint

Change in total motility of sperm from baseline and between the treatment arms

Time frame:Baseline and 24 weeks

change from baseline, improvement

Primary/protocol endpoint

Change in normal sperm forms from baseline and between the treatment arms

Time frame:Baseline and 24 weeks

change from baseline, improvement

Primary/protocol endpoint

Change in total number of sperm from baseline and between the treatment arms

Time frame:Baseline and 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in follicle-stimulating hormone (FSH) from baseline and between the treatment arms

Time frame:Baseline and 24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in luteinizing hormone (LH) from baseline and between the treatment arms

Time frame:Baseline and 24 weeks

Androgen, change

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.