Atorvastatin, L-Carnitine and Non-Alcoholic Steatohepatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of Atorvastatin v. Placebo on HCC Risk

NCT05028829

Liver Fibroses Cirrhosis

RECRUITING PHASE2

A Phase 2b Study of Icosabutate in Fatty Liver Disease

NCT04052516

Non Alcoholic Steatohepatitis (NASH)

COMPLETED PHASE2

Nonalcoholic Fatty Liver Disease (NAFLD) Pharmacological Treatment: Metformin Versus Atorvastatin

NCT01544751

Nonalcoholic Fatty Liver Disease (NAFLD)

UNKNOWN NA

LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)

NCT04328077

NASH - Nonalcoholic Steatohepatitis

COMPLETED PHASE2

Evaluation of the Effectiveness of the Use of a Carnitine-Orotate Complex and Biphenyl Dimethyl Dicarboxylate in the Pathogenetic Therapy of Metabolic-associated Fatty Liver Disease: a Prospective Cohort Study

NCT06078722

Metabolic-associated Fatty Liver Disease (MAFLD)

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of disease ranging from steatosis to steatohepatitis (nonalcoholic steatohepatitis, NASH) to cirrhosis. Statins are competitive inhibitors of Hydroxymethylglutaryl-CoA reductase, the rate-limiting step in cholesterol biosynthesis. They occupy a portion of the binding site of Hydroxymethylglutaryl-CoA, blocking access of this substrate to the active site on the enzyme. A reduction in intrahepatic cholesterol leads to an increase in LDL receptor turnover that results from an enhanced rate of hepatic LDL receptor cycling. On the other hand recent studies have implicated several important cellular processes and signaling pathways that are affected by abnormal lipid metabolism, resulting in specific biochemical, histological, and clinical changes associated with NAFLD.

Maybe statins, as lipid lowering agents, and through their effect in reduction of intrahepatic cholesterol, can affect the abnormal lipid metabolism in NASH.

L- carnitine, can improve the outcome of NASH, because it reduces lipid levels, limits oxidative stress, and modulates inflammatory responses . 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-alcoholic Steatohepatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Atorvastatin

20mg atorvastatin daily

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Atorvastatin 20 mg

Carnitine

1000mg L-carnitine daily

Group Type EXPERIMENTAL

L-Carnitine

Intervention Type DRUG

1000mg L-carnitine

Atoral

1000mg L-carnitine and 20mg atorvastatin

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Atorvastatin 20 mg

L-Carnitine

Intervention Type DRUG

1000mg L-carnitine

Placebo

Identically looking placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Identically looking placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Atorvastatin

Atorvastatin 20 mg

Intervention Type DRUG

L-Carnitine

1000mg L-carnitine

Intervention Type DRUG

Placebo

Identically looking placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* NASH diagnosed on the basis of the following criteria:

1. Imaging techniques showing evidence of hepatic steatosis
2. Increased alanine transaminase above 1.5 times normal (normal: 20 IU/L for women, 30 for men) on two occasions three months apart.

Exclusion Criteria

* Patients with hepatitis B or C
* alanine transaminase \> 300 IU/L
* Participants presenting one or more causes commonly associated with secondary NAFLD (drugs, surgical procedures, environmental toxins, or total parenteral nutrition)
* Alcohol ingestion greater than 40 gr per week
* Abnormal Lipid profile (TG\>500 , LDL\>160)
* Patients with hypertension, diabetes mellitus, coronary heart disease
* Fibroscan score more than 14 kp
* pregnancy, lactation
* Drug addiction
* Reynolds Risk Score \> 10%
* Not consenting to the study

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No