NCT05542147Completed
Genetic-Dependent Cardiovascular Response to PPAR-Alpha Agonist Fenofibrate
Physiopathological Study of Genetic Modulation of Cardiovascular Effect of PPAR-Alpha Activation (MAGNETIC-PPARA)
Source: ClinicalTrials.gov · Last updated 11 Aug 2025
Brief summary (registry, in English)
Fenofibrate, a peroxisome proliferator-activated receptor-alpha (PPAR-a) agonist known to improve diabetic dyslipidemia, has been proposed as a drug to prevent cardiovascular disease (CVD) in type 2 diabetes (T2D). However, the results of clinical trials have been mixed. Supporting the hypothesis that these disappointing results hide a genetic heterogeneity in the CVD response to fenofibrate, a common genetic variant (rs6008845) in the gene coding for PPAR-a has been found to dramatically influence the ability of this drug to reduce CVD events in the ACCORD Lipid trial (PMID:31974142). The aim of this study is to validate these findings by dissecting the pathways and mechanism through which this variant exerts such a modulatory effect, by means of a randomized clinical trial. If successful, this project will pave the way to a precision medicine approach to prescribe fenofibrate optimally, offering a cardio-protective drug to those patients that are most likely to experience a robust benefit from this medication.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 8 Sept 2022
- Start date
- 3 Jul 2022
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- Mario Luca Morieri
- Diseases
- Type 2 diabetes
- NCT number
- NCT05542147
What you commit to
- Study type: Interventional
- Participants enrolled: 200
- From 3 Jul 2022 to the primary completion date, 30 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled hypertension with systolic blood pressure \> 170 mmHg at enrollment.
- Hereditary muscle disorders
- Hepatic failure
- Allergy to fenofibrate or excipients
Lab values
- CKD III stage with eGFR\<60 ml/min/1.73
Other
- Uncontrolled hypothyroidism
- Elevated alcohol consumption
- Acute / chronic pancreatitis
- Pregnancy and lactation
Who the study is looking for
- Type 2 diabetes with previous cardiovascular events or at least one CV risk factor (hypertension, obesity, smoke, age\>65 years)
- HbA1c \< 8%
- Triglycerides \< 200 mg/dl
- On statin treatments and with LDLcholesterol \< 100 mg/dl or at maximum statin-tolerated dose
- European ancestry (rational: given the relatively small sample size and the ancestry-differences in allele frequency of rs6008845 T allele \[i.e. from 65% in whites to 20% in blacks subjects) this criteria allows to limit ethnic-confounding factors that would reduce the probability of success of this physiopathological study aiming to dissect the mechanism of the genetic modulation of fenofibrate effectiveness).
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Padova Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.