Atorvastatin, L-Carnitine and Non-Alcoholic Steatohepatitis

What Was Tested

This registered phase 2 trial tested L-Carnitine.

The aim of the present study was to compare the effects of simvastatin and L-carnitine coadministration versus simvastatin, L-Carnitine monotherapy on liver transaminases and liver elasticity in NASH patients.

It had four arms (groups): Atorvastatin (experimental), Carnitine (experimental), Atoral (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of disease ranging from steatosis to steatohepatitis (nonalcoholic steatohepatitis, NASH) to cirrhosis.

They occupy a portion of the binding site of Hydroxymethylglutaryl-CoA, blocking access of this substrate to the active site on the enzyme.

It performs a number of essential intracellular and metabolic functions, such as fatty acid transport, detoxification of potentially toxic metabolites, regulation of the mitochondrial acyl-CoA / CoA ratio, and stabilization of cell membranes.

It has a pivotal role in the transport of long chain fatty acids across the inner mitochondrial membrane.

Who Took Part

The registry lists 440 planned participants were the target.

It was open to people of any sex aged from 40 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: NASH diagnosed on the basis of the following criteria:. Imaging techniques showing evidence of hepatic steatosis.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: patients with hepatitis b or c; alcohol ingestion greater than 40 gr per week; abnormal lipid profile (tg\>500 , ldl\>160).

How the Study Was Run

Design: randomized, factorial and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

As a double-blind L-Carnitine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2016-01-01 with completion listed for 2019-10.

It ran at 2 sites in Iran (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example Adverse drug events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 440 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.