NCT04104321

A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR)

A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy PK, Kinetics and Safety of Aramchol in Nonalcoholic Steatohepatitis (NASH) With Open-Label Part

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Galmed Research and Development, Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

An Open-Label Part was added: This part will enroll in selected sites which are less affected by the COVID-19 pandemic. 150 subjects with NASH and fibrosis confirmed by liver histology (F1-F3) will be randomized into 3 groups according to the post-baseline biopsy. The objective of the Open-Label Part is: * To evaluate the safety and PK of twice daily administration (BID) of Aramchol 300mg in subjects with NASH and liver fibrosis. * To explore the kinetics of histological outcome measures and Non-Invasive Tests (NITs) associated with NASH and fibrosis for the treatment duration of 24, 48 and 72 weeks. All patients will be allocated to Aramchol. Double Blind Part: This part is double blind, placebo controlled randomized in subjects with NASH and fibrosis stages 2-3 who are overweight or obese and have prediabetes or type 2 diabetes. The primary objectives of this part of the study are to evaluate the effect of Aramchol as compared to placebo on NASH resolution, fibrosis improvement and clinical outcomes related to progression of liver disease. Subjects will be randomized to receive Aramchol 300mg BID or matching placebo in a 2:1 randomization ratio. This double-blind phase of the study will recruit patients once the study will be continued.

Detailed description

A total of 150 subjects, including those already randomized to Aramchol 300 mg BID or Placebo, were to be randomized in a ratio of 1:1:1 to receive Aramchol 300 mg BID in the open-label (OL) part according to the grouping below: Group A: The post-baseline liver biopsy was to be conducted at Week 24 Group B: The post-baseline liver biopsy was to be conducted at Week 48 Group C: The post-baseline liver biopsy was to be conducted at Week 72 In order to more comprehensively explore the kinetics of histological outcome measures (e.g., are there subjects who did not show improvement in outcome at Weeks 24, 48, or 72, but improved with longer duration of treatment), a second post-baseline liver biopsy sample was to be collected for subjects whose post-baseline liver biopsy at Weeks 24 or 48, or 72 did not show at least one stage improvement in fibrosis (fibrosis non-responders). The second post-baseline liver biopsy sample was to be collected one year later (i.e., at Weeks 72 or 96 or 120, respectively). Subjects already randomized and ongoing in the PC part were given the option to switch to the OL part

Conditions

• Nonalcoholic Steatohepatitis (NASH)

Interventions

Type	Name	Description
DRUG	Aramchol free acid	Aramchol 300 mg BID
DRUG	Placebo	Placebo BID

Timeline

• Start date: 2019-09-23
• Primary completion: 2022-12-08
• Completion: 2027-06-30
• First posted: 2019-09-26
• Last updated: 2026-02-11
• Results posted: 2024-12-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study