DelfaGLP-1 Atlas

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CompletedPhase 4

Testosterone Replacement Therapy and Liraglutide Effects on Weight Loss in Hypogonadism.

Effects of Liraglutide and Testosterone Replacement Therapy on Features of Hypogonadism and Weight Loss in Obese Men With Persistent Features of Hypogonadism.

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

30

actual

Study population

Obesity / overweight, Reproductive / infertility

Key I/E criteria

•BMI ≥30•Male

Primary endpoints

•Main outcome was improvements of symptoms related to hypogonadism•Androgen, change•Main outcome was change in gonadotropin levels

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 IDNCT03619330
Org study IDTESTOSTERON

Timeline

Milestones

Study first posted2018-08-07actual
Last update posted2018-08-07actual
Study start2014-12 (month precision)
Primary completion2015-08actual (month precision)
Study completion2015-08actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweightReproductive / infertility

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexMale
Healthy volunteersNot accepted

Inclusion criteria

•Male participants aged 18 to 65 years.
•Obesity, defined as BMI >=30 kg/m^2.
•Diagnosed functional hypogonadism, defined as consistently low serum total testosterone below 11 nmol/L on at least two separate morning fasting measurements, plus at least two symptoms of sexual dysfunction and low or inappropriately normal gonadotropin levels.
•Previously poor responders to lifestyle measures, by weight reduction and recovery of functional hypogonadism.

Exclusion criteria

•Specific pathological etiologies suppressing the hypothalamus-pituitary-testicular axis, including hyperprolactinemia and endogenous Cushing syndrome.
•Clinically indicated evaluation showing hypopituitarism, pituitary tumor, hypothalamic tumor, or infiltrative disease.
•Iron overload.
•History of carcinoma.
•Venous thromboembolism.
•Thrombophilia.
•Known preexisting cardiovascular disease or stroke.
•Initial PSA >3 ng/L.
•Severe lower urinary tract symptoms with International Prostate Symptom Score (IPSS) >19.
•Untreated sleep apnea.
•Initial hematocrit >50%.
•Significant kidney or liver disease.
•Active desire for fertility.
•Opioid or glucocorticoid use.
•Personal or family history of MEN 2.

Endpoints (8)

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

Glycemic / diabetes
3
Other clinical outcomes
3
Weight & body composition
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

The secondary outcome was change in body weight.

Time frame:Patient's body weight in kilograms were measured at the base point and every four weeks during the 16 weeks of clinical trial.

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

The secondary outcome was change in waist circumference.

Time frame:Patient's waist circumference was measured at the basepoint and every four weeks during 16 weeks of clinical trial.

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Other/protocol endpoint

The other outcomes was changes changes in fasting concentrations of glucose.

Time frame:Patient's fasting blood was drawn at the basepoint and and the end of the 16 weeks of clinical trial.

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Other/protocol endpoint

Other outcome was change in fasting concentration of insulin.

Time frame:Patient's fasting blood was drawn at the basepoint and and the end of the 16 weeks of clinical trial.

change from baseline, improvement

Other/protocol endpoint

Other outcome was change in HOMA IR index for insulin resistance.

Time frame:Patient's fasting blood was drawn at the basepoint and and the end of the 16 weeks of clinical trial.

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other clinical outcomes

3 endpoints
Primary/protocol endpoint

The main outcome was improvements of symptoms related to hypogonadism

Time frame:Patients were screened and asked for symptoms at the beginning and every 4 weeks for 16 weeks of the study.

descriptive, improvement

Primary/protocol endpoint

The main outcome was change testosterone level.

Time frame:Patient's blood was drawn at the base point and every four weeks during 16 weeks of clinical trial.

Androgen, change

change from baseline, improvement

Primary/protocol endpoint/low confidence

the main outcome was change in gonadotropin levels.

Time frame:Patient's blood was drawn at the base point and every four weeks during 16 weeks of clinical trial.

change from baseline, improvement

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.