Non-alcoholic SteatohepatitisPhase 2NALCATNCT01617772
Atorvastatin, L-Carnitine and Non-Alcoholic Steatohepatitis
A Phase 2 study testing Atorvastatin and L-Carnitine in people with Non-alcoholic Steatohepatitis, run by Tehran University of Medical Sciences at 2 sites in Iran.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Non-alcoholic Steatohepatitis
- What is being tested?
- Atorvastatin and L-Carnitine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 2 sitesIran
- Study dates
- 1 Jan 2016to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- NASH diagnosed on the basis of the following criteria:
- Imaging techniques showing evidence of hepatic steatosis
- Increased alanine transaminase above 1.5 times normal (normal: 20 IU/L for women, 30 for men) on two occasions three months apart.
Who cannot join
- 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
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- Fibroscan score more than 14 kp
- pregnancy, lactation
- Drug addiction
- Reynolds Risk Score > 10%
- Not consenting to the study
Trial locations and contacts
2 sites in 1 country.
Iran2 sites, 1 recruiting
- Active, not recruiting
Pars Cohort Center
Shiraz, Fars
- Recruiting
Masoud Clinic
Tehran, 14117
Shahin Merat, +989171173966, shahin.merat@gmail.com
About this study
Official title: Comparison the Effectiveness of L-Carnitine With Atorvastatin in Non-Alcoholic Steatohepatitis (NASH)
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.
Read the detailed description
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
- Non-alcoholic Steatohepatitis
- Being tested
- Atorvastatin, L-Carnitine, Placebo
- Keywords
- Non-alcoholic steatohepatitis, Atorvastatin, L-Carnitine
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Atorvastatin 20 mg
L-CarnitineDrug
1000mg L-carnitine
PlaceboDrug
Identically looking placebo
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | 20mg atorvastatin daily Receives: Drug: Atorvastatin |
| Carnitine | Experimental | 1000mg L-carnitine daily Receives: Drug: L-Carnitine |
| Atoral | Experimental | 1000mg L-carnitine and 20mg atorvastatin Receives: Drug: Atorvastatin; Drug: L-Carnitine |
| Placebo | Placebo comparator | Identically looking placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in liver stiffness
As measured by Fibroscan
Measured: 2 years
Secondary outcomes (2)
improvement in liver enzyme levels
Difference between last and first measurements
Measured: 2 years
Adverse drug events
questionnaire
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study start1 Jan 2016
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reza Malekzadeh, MD, Study chair, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617772
- Sponsor's protocol ID
- 90-03-37-15428
- Acronym
- NALCAT
- Status last verified
- May 2018
- First submitted
- 8 Jun 2012
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison the Effectiveness of L-Carnitine With Atorvastatin in Non-Alcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT01617772
- Acronym / sponsor ID
- NALCAT / 90-03-37-15428
- Conditions
- Non-alcoholic Steatohepatitis
- Keywords
- Non-alcoholic steatohepatitis, Atorvastatin, L-Carnitine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Drug: Atorvastatin20mg atorvastatin daily |
| Carnitine | Experimental | Drug: L-Carnitine1000mg L-carnitine daily |
| Atoral | Experimental | Drug: Atorvastatin, Drug: L-Carnitine1000mg L-carnitine and 20mg atorvastatin |
| Placebo | Placebo comparator | Drug: PlaceboIdentically looking placebo |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- NASH diagnosed on the basis of the following criteria:
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAtorvastatin 20 mg | Drug | Atoral, Atorvastatin |
| L-Carnitine1000mg L-carnitine | Drug | Atoral, Carnitine |
| PlaceboIdentically looking placebo | Drug | Placebo |
Primary outcome
improvement in liver stiffness
Time frame: 2 years
As measured by Fibroscan
2 secondary outcomes
improvement in liver enzyme levels
Time frame: 2 years
Adverse drug events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reza Malekzadeh, MD study chair
Tehran University of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin and L-Carnitine in people with Non-alcoholic Steatohepatitis, run by Tehran University of Medical Sciences at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shahin Merat, Professor (+98 917 117 3966, merat@tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in liver stiffness (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.