6 Participants Needed

FNP-59 for High Cholesterol

JP
BV
Overseen ByBenjamin Viglianti, M.D, Ph.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications like steroids, oral contraceptives, spironolactone, estrogen, androgen, progesterone, ACE inhibitors, ARBs, or hormone analogue supplements to participate in this trial.

How does the drug FNP-59 differ from other high cholesterol treatments?

FNP-59, also known as fluvastatin, is unique because it is a wholly synthetic statin, unlike other statins derived from fungal metabolites. It has a short exposure time in the body and is specifically targeted to the liver, where it is rapidly metabolized, making it different from other cholesterol-lowering drugs.12345

What is the purpose of this trial?

This exploratory, first-in-man, phase 0 study will evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of NP-59 (\[18F\]FNP-59) to image the adrenal gland in healthy normal subjects. The researchers believe that \[18F\]FNP-59 would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry.

Research Team

BV

Ben Viglianti, M.D, Ph.D.

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for healthy individuals without any adrenal gland issues. They must not be pregnant, imprisoned, or unable to consent. Participants should not be on steroids, certain blood pressure medications (ACE inhibitors/ARBs), hormone treatments like oral contraceptives, or weigh over 400 lbs.

Inclusion Criteria

My adrenal glands are healthy and I have no known adrenal diseases.

Exclusion Criteria

Pregnancy
I cannot undergo imaging tests.
I have a diagnosed adrenal gland condition.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants receive a sub-therapeutic dose of [18F]FNP-59 for PET imaging to evaluate cholesterol trafficking in the adrenal gland

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

1-2 weeks

Treatment Details

Interventions

  • [18F]FNP-59
Trial Overview [18F]FNP-59 is being tested as a new PET imaging agent that could potentially provide clearer images of the adrenal glands with less radiation exposure compared to current methods. This phase 0 study involves a single sub-therapeutic dose in normal subjects.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Group 1Experimental Treatment1 Intervention
These subjects, 6 planned (3 male, 3 female), will be to obtain normal tissue distribution of \[18F\]NP-59 and confirm calculated radiation dosimetry and optimal uptake time.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Benjamin Viglianti

Lead Sponsor

Trials
2
Recruited
30+

Findings from Research

Fluvastatin effectively lowers LDL cholesterol levels by 22-31% in patients with severe primary hypercholesterolemia and by 19-25% in those with familial hypercholesterolemia, demonstrating its efficacy as a cholesterol-lowering medication.
Fluvastatin is a cost-effective option for managing hypercholesterolemia, priced 40% lower than other statins, and has a favorable safety profile with manageable side effects, including reversible increases in liver enzymes.
A review of current clinical findings with fluvastatin.Garnett, WR.[2019]
In a study of 423 hypercholesterolemic patients, 6 weeks of treatment with fluvastatin significantly reduced harmful lipoprotein particles (apo B, LpE:B, and LpC-III:B) compared to placebo, indicating its efficacy in improving lipid profiles.
Fluvastatin treatment also led to increases in beneficial lipoproteins (apo A-I and LpA-I), suggesting that it not only lowers bad cholesterol but also enhances protective factors against coronary artery disease.
Fluvastatin reduces levels of plasma apo B-containing particles and increases those of LpA-I. European Fluvastatin Study Group.Dallongeville, J., Fruchart, JC., Pfister, P., et al.[2019]
In a study of 24 patients with familial hypercholesterolemia over 104 weeks, fluvastatin significantly reduced total cholesterol by 26.8% and LDL cholesterol by 33.1%, demonstrating its efficacy in managing high cholesterol levels.
The treatment also led to a 35% reduction in the LDL-C: HDL-C ratio, indicating improved cholesterol balance, while increases in HDL cholesterol were observed, although they were variable.
Clinical efficacy of fluvastatin in the long-term treatment of familial hypercholesterolemia.Koizumi, J., Haraki, T., Yagi, K., et al.[2019]

References

A review of current clinical findings with fluvastatin. [2019]
Fluvastatin reduces levels of plasma apo B-containing particles and increases those of LpA-I. European Fluvastatin Study Group. [2019]
Clinical efficacy of fluvastatin in the long-term treatment of familial hypercholesterolemia. [2019]
A Systematic Review and Meta-Analysis of Therapeutic Efficacy and Safety of Alirocumab and Evolocumab on Familial Hypercholesterolemia. [2022]
Efficacy and safety of a combination fluvastatin-bezafibrate treatment for familial hypercholesterolemia: comparative analysis with a fluvastatin-cholestyramine combination. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security