Fenofibrate for Klinefelter Syndrome

Overseen By Julia Byers, BA

Age: < 65

Sex: Male

Trial Phase: Phase 4

Sponsor: University of Colorado, Denver

Must not be taking: PPAR agonists, Statins

Disqualifiers: Liver disease, Renal impairment, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

44 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will learn more about how the body uses energy. Usually, the body uses sugars as energy first and then fats are used when the sugar stores are gone. Some people have trouble using fats as energy. This can lead to feeling tired, difficulty exercising, and storing too much fat where it does not belong (like in the muscle). It is believed that some boys and men with Klinefelter Syndrome may not be able to use fats as energy normally, and that a medication called fenofibrate could help this.

Will I have to stop taking my current medications?

The trial requires that you have not taken a PPAR agonist (a type of medication that includes fish oil) or statin in the past month. Also, your medications should be stable, meaning no changes in the past two weeks and no planned changes during the study.

Is Fenofibrate safe for humans?

Fenofibrate, also known as Tricor, Lofibra, Fenoglide, Lipofen, and Triglide, has been used to treat high cholesterol and triglyceride levels in humans. It is generally considered safe when used as directed, but like any medication, it can have side effects such as stomach pain, back pain, headache, and respiratory issues. Always consult with a healthcare provider for personalized advice. ^{1 2 3 4 5}

How is the drug Fenofibrate unique for treating Klinefelter Syndrome?

Fenofibrate is unique for treating Klinefelter Syndrome because it targets dyslipidemia (abnormal cholesterol levels), which is a common issue in patients with this condition. Unlike testosterone replacement therapy, which addresses hormone deficiencies, Fenofibrate focuses on improving lipid profiles, potentially reducing the risk of cardiovascular diseases associated with Klinefelter Syndrome. ^{4 5 6 7 8}

Research Team

Shanlee M Davis, MD, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for males aged 15-40 with Klinefelter Syndrome (confirmed by genetic testing) and normal testosterone levels. Participants should not have liver disease, renal impairment, diabetes, untreated hypogonadism, or recent use of certain medications like PPAR agonists or statins.

Inclusion Criteria

My genetic test confirmed I have Klinefelter syndrome.

My testosterone levels are normal for my age and development stage.

I am between 15 and 40 years old.

Exclusion Criteria

Inability to tolerate study procedures, including any medical conditions that make exercise unsafe at the discretion of the study physician

My kidneys are not working well (creatinine clearance <80 ml/min).

My diabetes is confirmed with an A1c level over 6.4%.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants with Klinefelter Syndrome receive fenofibrate, 145mg PO daily for 4 weeks

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fenofibrate

Trial Overview The study tests if fenofibrate can help boys and men with Klinefelter Syndrome use fats as energy more effectively. It aims to see if this treatment reduces fatigue and improper fat storage in muscles.

Participant Groups

Group I: Arm 2 (Interventional with cases) Experimental Treatment 1 Intervention

Cases (those with Klinefelter); Comparison of outcomes pre and post fenofibrate intervention, 145mg PO daily for 4 weeks

Group II: Arm 1 (Cross-sectional, Cases v. Controls) Active Control 1 Intervention

Cases (those with Klinefelter) vs. controls (those without Klinefelter)

Fenofibrate is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Fenofibrate for:

• High cholesterol
• Severe high triglycerides

Approved in European Union as Fenofibrate for:

• Mixed hyperlipidemia
• Primary hypercholesterolemia
• Severe hypertriglyceridemia

Approved in Canada as Fenofibrate for:

• Hyperlipidemia
• Hypertriglyceridemia

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

References

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Increased Endothelial Dysfunction and Insulin Resistance in Patients with Klinefelter Syndrome. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Klinefelter's syndrome associated with systemic lupus erythematosus and autoimmune hepatitis. [2016]

3. Norway pubmed.ncbi.nlm.nih.gov

Testosterone and the child (0-12 years) with Klinefelter syndrome (47XXY): a review. [2013]

4. Japan pubmed.ncbi.nlm.nih.gov

Klinefelter syndrome in an adolescent with severe obesity, insulin resistance, and hyperlipidemia, successfully treated with testosterone replacement therapy. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Population-based Assessment of Cardiometabolic-related Diagnoses in Youth With Klinefelter Syndrome: A PEDSnet Study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Glucose metabolic disorder in Klinefelter syndrome: a retrospective analysis in a single Chinese hospital and literature review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of Oxandrolone on Cardiometabolic Health in Boys With Klinefelter Syndrome: A Randomized Controlled Trial. [2022]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Hypogonadism Makes Dyslipidemia in Klinefelter's Syndrome. [2018]