Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02279524 | A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH | PHASE2 | COMPLETED | 247 | — | — | Apr 29, 2015 | May 22, 2018 | Jul 14, 2021 | 78 | United States, Chile +9 |
absolute % change from baseline to end of study in liver triglycerides to water ratio (fat/water+fat) as measured by MRS
| Arm | Type | Description |
|---|---|---|
| Aramchol 600mg | EXPERIMENTAL | One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg. |
| Aramchol 400mg | EXPERIMENTAL | One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol. |
| Placebo | PLACEBO_COMPARATOR | Two tablet of Aramchol matching placebo. |
| Name | Type | Description |
|---|---|---|
| Aramchol | DRUG | Subjects will be administered Aramchol as follows: * One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol. * One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg. * Two tablet of Aramchol matching placebo. The tablets should be taken orally in the morning within 30 min after breakfast with a glass of water (250 ml). Subjects are allowed to omit study drugs up to 3 consecutive days during the study. |
Inclusion Criteria: 1. Male or female age 18 to 75 years. 2. BMI between 25kg/m2 to 40kg/m2 or waist circumference between 88 cm to 200 cm for women, and between 102 cm to 200 cm for men. If there is deviation above the upper limit, please consult the MRI center, to ensure that the machine is suita...