Single and Multiple Dose PK of Aramchol from an Aramchol Meglumine Tablet
Research type
Research Study
Full title
A Phase 1 open-label clinical trial in healthy adult volunteers to evaluate the exposure of aramchol from 2 different single doses of an aramchol meglumine tablet, and to compare the exposure at steady state from a selected dose of aramchol meglumine given once daily to that from a 300 mg dose of aramchol free acid tablets given twice daily.
IRAS ID
1013148
Contact name
Irit Gliko-Kabir
Contact email
Sponsor organisation
Galmed Research and Development Ltd
Clinicaltrials.gov Identifier
Research summary
The trial medicine is an experimental treatment for treating metabolic dysfunction-associated steatohepatitis (MASH), a type of fatty liver disease which causes inflammation and scarring. If the disease progresses it can cause permanent liver damage, liver failure (where the liver stops working properly) and liver cancer. There are currently no available treatments for MASH, but the results of early clinical trials suggest that aramchol reduces liver fat and liver scarring in people with MASH, so it may be a useful treatment.
We’re doing this trial in healthy volunteers to find out the blood levels and side effects of the tablet form of aramchol, called aramchol meglumine (AM), and to compare it to the existing tablet form of aramchol, called aramchol free acid.
This is a 2 parts trial in healthy men and women, aged 18-55. In Part A, 12 participants will have 2 sessions where they’ll receive a single oral dose of AM in each session. In Part B, up to 20 participants (grouped into 2 groups of 10) will have a single period of residence in the study unit where they’ll receive either twice-daily doses of aramchol free acid for 10 days, or a once-daily dose of AM for 10 days.
In Part A participants will take about 4 weeks to finish the trial. They’ll make up to 11 outpatient visits, and stay on the ward for 3 nights in each of the two sessions. In Part B, participants will take up to 4 weeks to finish the trial. They’ll make up to 1 outpatient visit, and stay on the ward for 11 nights in a row.
A pharmaceutical company called Galmed Research and Development Ltd is funding the trial.
The trial will take place at 1 centre in London.REC name
London - London Bridge Research Ethics Committee
REC reference
25/LO/0775
Date of REC Opinion
24 Nov 2025
REC opinion
Further Information Favourable Opinion