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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether fenofibrate, a medication, can help boys and men with Klinefelter Syndrome use fats for energy more efficiently. Individuals with this condition often feel tired, struggle with exercise, and store fat in unusual places, such as muscles. The study will compare those with Klinefelter Syndrome to those without, assessing how fenofibrate affects their energy use before and after taking the medication. Men aged 15 to 40 with Klinefelter Syndrome and normal testosterone levels might be suitable for this trial. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment can benefit more patients.

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.

What is the safety track record for fenofibrate?

Studies have shown that fenofibrate is generally well-tolerated. Research indicates that it significantly lowers certain blood fats, such as triglycerides and LDL cholesterol, often called "bad" cholesterol. These benefits appear not only in clinical trials but also in everyday use.

Most people taking fenofibrate experience only mild side effects, like an upset stomach or headache, while serious side effects are rare. Its safe use for other conditions suggests it is a dependable treatment. However, individual reactions vary, so monitoring for changes and consulting a healthcare provider if anything unusual occurs is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for Klinefelter Syndrome, which primarily focus on hormone replacement therapy to address testosterone deficiency, fenofibrate offers a novel approach by targeting lipid metabolism. Fenofibrate is unique because it acts as a peroxisome proliferator-activated receptor alpha (PPARα) agonist, helping to improve lipid profiles and potentially addressing metabolic issues associated with Klinefelter Syndrome. Researchers are excited about fenofibrate because it could provide additional benefits beyond hormonal therapy, offering a more comprehensive treatment strategy for those affected by this condition.

What evidence suggests that fenofibrate might be an effective treatment for Klinefelter Syndrome?

Research shows that fenofibrate helps the body use fats for energy. In people with metabolic syndrome, fenofibrate significantly lowers triglyceride levels (a type of fat in the blood) within 5 to 7 months. For heart health, it reduces the risk of heart disease by 11% over five years. In this trial, participants with Klinefelter Syndrome will receive fenofibrate to assess its potential benefits, as they may have trouble using fats for energy. This could boost energy levels and reduce unwanted fat storage. ^{1 2 3 4 6}

Who Is on the Research Team?

Shanlee M Davis, MD, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05498090

Study Details | NCT05498090 | Interrogating Fatty Acid ... 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 ...

2. withpower.com withpower.com/trial/phase-4-klinefelter-syndrome-8-2022-934cf

Fenofibrate for Klinefelter Syndrome · Info for Participants 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10594425/

Effectiveness and Safety of Fenofibrate in Routine ... In our study, the use of fenofibrate for metabolic syndrome patients resulted in a two-fold TG level decrease in 5–7 months of treatment.

4. academic.oup.com academic.oup.com/edrv/advance-article/doi/10.1210/endrev/bnaf005/8008615

New Horizons in Klinefelter Syndrome: Current Evidence ... These results are consistent with previous findings placing the early detectability of gonadal failure at the peri-pubertal stage (88-90, 92, 103, 106, 107).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2646035/

Effects of Fenofibrate Treatment on Cardiovascular Disease ... Among individuals with metabolic syndrome, fenofibrate reduced the 5-year CVD risk from 14.5 to 13.1%, representing a proportional risk reduction of 11% ( ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03696940

Clinical Trial to Evaluate the Efficacy of a Dyslipidemic ... Clinical Trial Phase III, experimental, simple blind, randomized with two treatment groups, multicentric, longitudinal, to evaluate the therapuetic efficacy ...