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Fibrate
Fenofibrate for Klinefelter Syndrome
Phase 4
Recruiting
Led By Shanlee M Davis, MD, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For the KS group only: genetic testing results confirming KS
Ages 15 to 40 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
Study Summary
This trial will study whether fenofibrate can help boys and men with Klinefelter Syndrome who have trouble using fats as energy.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Fenofibrate may cause side effects such as liver enzyme increases, muscle tenderness or weakness, abdominal pain, nausea, headache, and increased risk of developing gallstones.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My genetic test confirmed I have Klinefelter syndrome.
Select...
I am between 15 and 40 years old.
Select...
My testosterone levels are normal for my age and development stage.
Select...
I am male.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
maximal rate of fat oxidation
skeletal muscle fat oxidation
Secondary outcome measures
Genes
Genes
Side effects data
From 2013 Phase 3 trial • 575 Patients • NCT016747122%
DIARRHOEA
1%
INTESTINAL HAEMORRHAGE
1%
ANGINA PECTORIS
1%
VESTIBULAR DISORDER
1%
UMBILICAL HERNIA, OBSTRUCTIVE
1%
NON-SITE SPECIFIC INJURIES NEC
1%
NASOPHARYNGITIS
1%
BLOOD CREATINE PHOSPHOKINASE INCREASED
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fenofibrate/Simvastatin 145/40 mg
Simvastatin 40 mg
Fenofibrate 145 mg
Fenofibrate/Simvastatin 145/20 mg
Simvastatin 20 mg
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2 (Interventional with cases)Experimental Treatment1 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 Control1 Intervention
Cases (those with Klinefelter) vs. controls (those without Klinefelter)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fenofibrate 145 mg
2012
Completed Phase 4
~1770
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,315,451 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,736 Previous Clinical Trials
2,149,151 Total Patients Enrolled
5 Trials studying Klinefelter Syndrome
471 Patients Enrolled for Klinefelter Syndrome
Shanlee M Davis, MD, PhDPrincipal InvestigatorUniversity of Colorado, Denver
2 Previous Clinical Trials
10,000 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My genetic test confirmed I have Klinefelter syndrome.My kidneys are not working well (creatinine clearance <80 ml/min).My diabetes is confirmed with an A1c level over 6.4%.My testosterone levels are normal for my age and development stage.I have untreated low testosterone or hormone imbalance.I am between 15 and 40 years old.I have taken a PPAR agonist or statin in the last month.I am male.My medications have been stable for the last 2 weeks and I don't plan to change them during the study.My liver tests are not more than three times the normal limit.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 (Cross-sectional, Cases v. Controls)
- Group 2: Arm 2 (Interventional with cases)
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is being considered for participation in this medical investigation?
"This research is in need of 44 individuals with xxxy males between 15 and 40. To be eligible, applicants should possess the following qualifications: Male gender, Age within the range of 15 to 40 years old, Testosterone levels that are consistent with their age and stage of puberty and For those who fit into the KS group: laboratory results confirming KS diagnosis."
Answered by AI
Are there still available slots to join this experiment?
"According to documents on clinicaltrials.gov, this research program is not actively seeking participants at the moment; it was initially posted on September 1st 2022 and recently updated August 9th 2022. Nevertheless, there are 1385 other trials enrolling patients right now."
Answered by AI
Does eligibility for this clinical trial extend to adults over eighteen?
"As per the conditions of this medical study, participants must be between 15 and 40 years old."
Answered by AI
Has the Federal Drug Administration (FDA) ratified Fenofibrate 145 mg?
"The safety level of Fenofibrate 145 mg is evaluated as a 3 due to existing approval by the Phase 4 trial, implying that it has been tested for efficacy and security."
Answered by AI
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