KLIN-HEALTH

RecruitingPhase 3

Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome

Dissecting the Importance of Sex Steroids Balance for Metabolic and Reproductive Health in Men With Klinefelter Syndrome: a Randomized Controlled Study

Lead sponsor

Georgios Papadakis

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

150

Study population

Metabolic syndrome, Obesity / overweight, Reproductive / infertility

Eligibility highlights

•BMI 25-28•Male

Primary endpoints

•Design 1•HOMA-IR (insulin sensitivity)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05586802

Org study IDPZ00P3_202151

Timeline

Milestones

Study first posted2022-10-19actual

Study start2023-03-21actual

Last update posted2026-05-11actual

Primary completion2027-04-30estimated

Study completion2027-04-30estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Metabolic syndromeObesity / overweightReproductive / infertility

Who can enroll

Minimum age16 Years

Maximum age65 Years

SexMale

Healthy volunteersNot accepted

Inclusion criteria

-Diagnosis of Klinefelter syndrome (47,XXY or mosaicism)

Design 1:

•Age range: 16-40 years old

•Intention to become parent or interest in fertility preservation

•Confirmed azoospermia (lack of spermatozoids) after centrifugation of one semen sample

Design 2:

•Age range: 18-65 years old

•No interest in fertility or fertility preservation

•Hypogonadism at diagnosis or after wash-out of testosterone replacement therapy

•High metabolic risk defined as overweight (BMI 25-28 kg/m2) and insulin resistance (HOMA-IR > 2.6)

Exclusion criteria

•Contraindications to testosterone-rising therapies (prostate or breast cancer, PSA > 4 µg/l, active liver disease, symptomatic heart disease)

•Decreased life expectancy due to terminal disease

•Known or suspected non-compliance, drug or alcohol abuse

•Inability to follow the procedures of the study (language problems, severe psychological or mental disorders)

Endpoints (2)

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

Other clinical outcomes

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

Design 2 : change in insulin resistance index (HOMA-IR)

Time frame:From baseline to week 26 of intervention

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other clinical outcomes

1 endpoint

Primary/protocol endpoint

Design 1 : sperm retrieval rate at mTESE biopsy

Time frame:mTESE biopsy 26 weeks after hormonal intervention

threshold achievement, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.