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Lifestyle Versus Ezetimibe Plus Lifestyle in Patients With Non-alcoholic Steatohepatitis

U

University of Palermo

Status and phase

Unknown
Phase 4

Conditions

•Non-alcoholic Steatohepatitis (NASH)

Treatments

Drug: Ezetimibe
Behavioral: Lifestyle

Study type

Interventional

Funder types

Other

Identifiers

NCT01950884
LISTEN
2013-003465-33 (EudraCT Number)

Details and patient eligibility

About

  • NAFLD (Non-alcoholic fatty liver disease) has become the most common cause of liver disease in Western countries (hepatic manifestation of insulin resistance);
  • NAFLD represents a cardiovascular risk factor;
  • Lifestyle modification(weight loss)is the effective medical treatment recommended for NASH (Non-alcoholic Steatohepatitis);
  • Ezetimibe could represent a novel safe treatment for NAFLD (Patel 2006. Here the investigators propose a Randomized Controlled Pilot Trial to evaluate the addictive effect of ezetimibe on liver histology, biochemical and sonographic parameters in a small (n.40) number of NASH patients randomized for 12 months in two arms: lifestyle vs lifestyle+ezetimibe.

Full description

to evaluate the addictive effect of ezetimibe on liver histology, biochemical and sonographic parameters in a small (n.40) number of NASH patients randomized for 12 months in two arms: lifestyle vs lifestyle+ezetimibe.

Enrollment

45 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 1.Patients older 18 years
  • 2.Histological diagnosis of possible or definite NASH, according to Kleiner scorw, within 6 months before randomization -

Exclusion criteria

  • 1)Average alcohol consumption > 20 g per day in women and > 30 g per day in men
  • 2)other causes of chronic liver disease 3) History of or planned gastrointestinal bypass or any additional bariatric surgery/intervention 4)Hepatic cirrhosis with Child-Pugh score of B or C, and/or concomitant HCC 5)Recent(within 6 months) or concomitant use of agents known to cause hepatic steatosis 7)Recent(within 6 months)change in dose/regimen or first treatment with vitamin E, C, betaine, s-adenosylmethionine, ursodeoxycholate, sylimarin, fibrate, statin, pentoxyfilline, angiotensin II inhibitors, orlistat, sibutramine 8)Ongoing or recent therapy (within 6 months) with vitamin D or with medications known to affect vitamin D3 metabolism 9)Any additional condition that might interfere with optimal partecipation in the study, according to Investigators opinion; 10)Be pregnant or breastfeeding.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 2 patient groups

Ezetimibe
Experimental group
Description:
Ezetimibe tablets plus lifestyle
Treatment:
Drug: Ezetimibe
Behavioral: Lifestyle
lifestyle
Active Comparator group
Description:
lifestyle
Treatment:
Behavioral: Lifestyle

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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