Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Aramchol meglumine, Aramchol free acid, Arachidyl amido cholanoic acid
Aramchol · 4 trials · 9 indications
absolute % change from baseline to end of study in liver triglycerides to water ratio (fat/water+fat) as measured by MRS
Measure the AUC(0-inf) of orally and intravenously (IV) administered Aramchol
Assess the mass balance recovery of total amounts of radioactivity excreted in urine and feces
Assess the potential metabolites of Aramchol and determine their chemical structure in plasma, urine and fecal samples
AUC from time 0 to the dosing interval tau measured at steady state. Blood was collected at the following time points: before dosing (0 hour) and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 48, 72, 96, 120, 144, 168, 192, and 240 hours
Maximum plasma concentrations (Cmax,ss) Blood was collected at the following time points: before dosing (0 hour) and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 48, 72, 96, 120, 144, 168, 192, and 240 hours
CL/F measured after single dose in Part 1 Blood was collected at the following time points: before dosing (0 hour) and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 48, 72, 96, 120, 144, 168, 192, and 240 hours
| 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. |
| high dose | EXPERIMENTAL | Aramchol 300 mg daily (high dose) |
| low dose | EXPERIMENTAL | 100 mg daily (low dose) |
| Single dose administration of Aramchol in Part 1 and Part 2 | EXPERIMENTAL | 6 subjects received Aramchol in Part 1 and Part 2 of the study |
| Part 1: Mild Hepatic Impairment (Cohort A) | EXPERIMENTAL | 8 mild hepatic impaired subjects |
| Part 1: Moderate Hepatic Impairment (Cohort B) | EXPERIMENTAL | 8 moderate hepatic impaired subjects |
| Part 1: Severe Hepatic Impairment (Cohort C) | EXPERIMENTAL | 8 severe hepatic impaired subjects |
| Part 1: Healthy Volunteers (Cohort D) | EXPERIMENTAL | 15 matched healthy volunteers |
| Part 2: Mild Hepatic Impairment Cohort | EXPERIMENTAL | 4 mild hepatic impaired subjects |
| Part 2: Moderate Hepatic Impairment Cohort | EXPERIMENTAL | 7 moderate hepatic impaired subjects |
| Part 2: Healthy Volunteers Cohort | EXPERIMENTAL | 7 matched healthy volunteers |
| 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. |
| Placebo | DRUG | tablets packaged in bottles given orally once a day in the morning within approximately 10 minutes after breakfast |
| Aramchol free acid tablet 600mg, single dose | DRUG | Aramchol free acid tablet 600mg, single dose |
| Aramchol free acid tablet 300mg, bid | DRUG | Aramchol acid tablet 300mg, bid for 12 days |
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...
Aramchol is an investigational small molecule being studied for fatty liver disease, including non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). It has also been evaluated in hepatic impairment. It is not approved for any indication and remains in clinical development.
Aramchol is being developed by Eocene Ltd., which trades under the ticker EOCN. The company has sponsored Phase 1 and Phase 2 studies of the drug in NASH, fatty liver disease, and hepatic impairment.
Aramchol is in Phase 2 development. Its clinical program includes completed Phase 2 trials in NASH and fatty liver disease, along with completed Phase 1 studies in NASH and hepatic impairment. It is investigational and has not been approved by the FDA.
Aramchol has been studied in completed trials including NCT02279524, a Phase 2 placebo-controlled trial in NASH with 247 patients, and NCT01094158, a Phase 2 study in fatty liver disease and NASH. Phase 1 trials NCT05874336 and NCT04480827 assessed bioavailability, mass balance, and pharmacokinetics in hepatic impairment.
Yes. Aramchol is also referred to as Aramchol meglumine and Aramchol free acid. These names describe different salt or free acid forms of the same investigational compound, and searches for any of them refer to the same drug candidate being developed for fatty liver disease and NASH.