Study Evaluating Efficacy and Safety of Aramchol in NASH Patients
Research type
Research Study
Full title
A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects with Nonalcoholic Steatohepatitis (NASH) with Open-Label Part to Evaluate the Safety, PK and Treatment Response Kinetics of Aramchol. The ARMOR Study
IRAS ID
271261
Contact name
Quentin Anstee
Contact email
Sponsor organisation
Galmed Research and Development, Ltd.
Eudract number
2019-002073-56
Duration of Study in the UK
7 years, 0 months, 0 days
Research summary
Research Summary:
This research is studying Aramchol, an investigational new drug made by Galmed Pharmaceuticals Ltd., as a possible treatment for Nonalcoholic Steatohepatitis (NASH). NASH is a chronic liver disease caused by the build-up of too much fat in the liver, along with inflammation and liver damage. As NASH progresses, it may cause scarring of the liver and liver failure. The purpose is to evaluate the effect of twice daily Aramchol 300mg on NASH and NASH-related complications compared to placebo and to examine its safety. This study would enrol a total of 2000 participants at approximately 200 clinical sites worldwide. Participants would be assigned to either receive Aramachol or Placebo at a ratio of 2:1. Participation is expected to be from 5-8 years. Participants will receive study drug (Aramachol or placebo) at each study visit once they are randomised onto the study and they will be provided with enough study drug until their next visit and instructed to take one tablet in the morning after a meal and one tablet in the evening after a meal. Screening may take up to 8 weeks. The baseline visit is the first visit where study drug would be given. There are then visits at weeks 4, 8, 12, 24, 36 & 52 (1yr). After the first year visits would be every 4 months up to 7 years.
This is a Phase 3, Multinational, Multicenter, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Participants (NASH)Summary of Research:
A total of 1326 women were enrolled; 658 were randomly assigned to receive whole-breast irradiation and 668 to receive no irradiation. The cumulative incidence of local breast cancer recurrence within the first 10 years was 9.5% (95% confidence interval [CI], 6.8 to 12.3) in the no-radiotherapy group and 0.9% (95% CI, 0.1 to 1.7) in the radiotherapy group Although local recurrence was more common in the group that did not receive radiotherapy, the 10-year incidence of distant recurrence as the first event was not higher in the no-radiotherapy group than in the radiotherapy group, at 1.6% (95% CI, 0.4 to 2.8) and 3.0% (95% CI, 1.4 to 4.5), respectively. Overall survival at 10 years was almost identical in the two groups, at 80.8% (95% CI, 77.2 to 84.3) with no radiotherapy and 80.7% (95% CI, 76.9 to 84.3) with radiotherapy.Omission of radiotherapy was associated with an increased incidence of local recurrence but had no detrimental effect on distant recurrence as the first event or overall survival among women 65 years of age or older with low-risk, hormone receptor–positive early breast cancer.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0357
Date of REC Opinion
6 Jan 2020
REC opinion
Further Information Favourable Opinion