CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 target
Drug / intervention
Aramchol +2 moredrug
Likely dose
Aramchol 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01094158
NCT01094158Phase 2Completed
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A Phase II Placebo Controlled Randomised Study of Aramchol on Liver Triglyceride in Patients With Steatosis Due to NAFLD or NASH

Galmed Medical Reserch·interventional·Posted Mar 26, 2010·Updated Jan 31, 2012

In Brief

A Phase 2 clinical trial evaluating Aramchol and Placebo for Non-Alcoholic Fatty Liver Disease and 2 related conditions. Completed, enrolled 60 participants across 11 sites.

Detailed Summary

Primary purpose: Compare the changes in liver triglycerides concentration in the Aramchol versus the placebo arm following three month treatment. Secondary purpose: Comparing liver enzymes, markers of endothelial dysfunction, insulin resistance, SCD1 activity and cholesterol synthesis and lipid levels, between the Aramchol and the placebo arms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, Metabolic Syndrome
CountriesIsrael
CollaboratorsTel-Aviv Sourasky Medical Center, Beilinson Hospital, Petach Tikva,Israel, Meir Medical Center, Kaplan Hospital ,Rehovot,Israel, Soroka Hospital,Beer Sheva,Israel, Hadassah Medical Organization, Hillel Yaffe Medical Center, Rambam Health Care Campus, The Lady Davis Carmel Medical Center, Holy Family Hospital, Nazareth, Israel, Ziv Hospital

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 26, 2010
Enrollment StartNov 1, 2010
Primary CompletionNov 1, 2011
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.3 years ago

Interventions

Aramcholdrug

100mg/d tablets packaged in bottles given orally once a day in the morning within 10 minutes after breakfast for a total period time of 3 months

Aramcholdrug

300 mg/d tablets packaged in bottles given orally once a day in the morning within 10 minutes after breakfast for a total period time of 3 months

Placebodrug

tablets packaged in bottles given orally once a day in the morning within approximately 10 minutes after breakfast