A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH
Public ClinicalTrials.gov record NCT02279524. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase IIb, Double Blind Randomized, Controlled Clinical Trial, to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH) - Aramchol 005 Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multicenter, Phase IIb, randomized, double blind, placebo-controlled study designed to evaluate the efficacy and safety of two Aramchol doses in subjects that are 18 to 75 years of age, with Non-Alcoholic Steatohepatitis (NASH) confirmed by liver biopsy performed in a period of 6 months before entering the study, with overweight or obesity and who are pre diabetic or type II diabetic. Eligible subjects will be enrolled into three treatments arms: Aramchol 400 and 600 mg tablets and placebo tablets in ratio 2:2:1. The subjects will be evaluated at study sites for 11 scheduled visits during one year (52 weeks). After completion of the study treatment period, the subjects will be followed for an additional period of 13 weeks without study medication (until visit 11 (week 65)).
Study identification
- NCT ID
- NCT02279524
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 247 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 28, 2015
- Primary completion
- May 21, 2018
- Completion
- May 21, 2018
- Last update posted
- Jul 13, 2021
2015 – 2018
United States locations
- U.S. sites
- 17
- U.S. states
- 6
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Profil Institue for Clinical Research Inc. | Chula Vista | California | 91911 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| California Liver Research Institute | Pasadena | California | 91105 | — |
| Inland Empoire Liver Foundation | Rialto | California | 92377 | — |
| University of California Department of Medicine Division of Gastroenterology | San Diego | California | 92103 | — |
| Orange County Research Center | Tustin | California | 92780 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Mount Sinai | New York | New York | 10029 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Wake Research | Raleigh | North Carolina | 27612 | — |
| Texas Digestive Disease Consultants | Dallas | Texas | 75246 | — |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | — |
| Gastroenterology Consultants of San Antonio | Live Oak | Texas | 78233 | — |
| Texas Liver Institute San Antonio | San Antonio | Texas | 78215 | — |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | — |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 61 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02279524, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 13, 2021 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02279524 live on ClinicalTrials.gov.