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

NCT04104321 | Suspended Phase 3 Results DMC FDA Drug

• 1 other identifier: Aramchol-018
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Nonalcoholic Steatohepatitis (NASH)

Keywords

fibrosis; liver fibrosis; diabetes; obesity

Outcome Measures

Primary Outcomes (3)

• Open Label Part: Improvement of Fibrosis Based on Liver Biopsy

  Improvement of fibrosis was defined by the following: 1. One stage or more reduction in fibrosis stage as assesed by the NASH-CRN classification 2. Ranked paired assessment between post-baseline compared to baseline biopsies (i,proved, worsened or stable fibrosis) 3. Reduction in the the continous phenotypic Fibrosis composite severity (Ph-FCS) score ≥0.3 in absolute value or ≥25% in relative value

  Up to 72 or 120 weeks

• Double Blind Part: To Evaluate the Effect of Aramchol Compared to Placebo on Liver Histology by Assessing the Following Primary Endpoints. Study Was Suspended and Thus Results Are Expected 2027

  * Resolution of NASH defined as the Proportion (%) of subjects with resolution of NASH (defined by Ballooning of 0 and inflammation 0-1) and no worsening of liver fibrosis, or * Improvement in Fibrosis defined as the Proportion (%) of subjects with improvement in liver fibrosis greater than or equal to one stage and no worsening of steatohepatitis.

  72 weeks

• Double Blind Part: To Evaluate the Effect of Aramchol Compared to Placebo on Composite Long-term Outcome Study Was Suspended so Results Expected 2027

  Proportion (%) of subjects experiencing at least 1 of the following events: All-cause mortality, Liver transplant, Histological progression to cirrhosis, MELD score \>15, Hospitalization due to hepatic decompensation event(s).

  at End of Study, latest at 5 years from last subject's randomization

Study Arms (2)

Aramchol free acid

EXPERIMENTAL

Aramchol 300 mg oral tablet

Drug: Aramchol free acid

Placebo

PLACEBO COMPARATOR

Placebo matching oral tablet

Drug: Placebo

Interventions

Aramchol free acid DRUG

Aramchol 300 mg BID

Also known as: Two tablets of Aramchol free acid

Aramchol free acid

Placebo DRUG

Placebo BID

Also known as: Two tablet of Aramchol matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age 18 to 75 years
• Histological confirmation of NASH on a diagnostic liver biopsy by central reading of the slides (biopsy obtained within 6 months prior to randomization or during the screening period)
• Total NAS Score 4 or more with at least 1 in each component of the NAS Score (steatosis ≥1 AND inflammation ≥1 AND ballooning ≥1)
• Fibrosis Stage must be 2 or 3 (Open-Label Part may include up to 30 subjects with fibrosis stage 1)
• Body mass index (BMI) between 25kg/m2 and 40 kg/m2 (Open Label part: BMI \<40 kg/m2)
• AST\>20 IU/L
• For subjects with type 2 diabetes, glycemia must be controlled
• Females of childbearing potential must practice a highly effective method of contraception throughout the study period and for 1 month after treatment discontinuation.
• Able to understand the nature of the study and to provide signature of the written informed consent.

You may not qualify if:

• Histologically documented liver cirrhosis (fibrosis stage 4)
• Inability or unwillingness to undergo a liver biopsy
• Abnormal synthetic liver function
• ALT or AST \>5× upper limit of normal (ULN)
• Platelet count \< 150,000mm3
• Alkaline phosphatase ≥2× ULN
• Known or suspected hepatocellular carcinoma (HCC)
• Model for End-Stage Liver Disease (MELD) score \> 12
• Prior history or presence of decompensated liver disease
• Other (acute or chronic) coexisting liver disease based on medical history and/or centralized review of liver histology)
• Known alcohol and/or any other drug abuse or dependence in the last five years
• Weight loss of more than 5% within 3 months prior to screening
• History of bariatric surgery within 5 years of liver biopsy or planned surgery for weight reduction
• Treatment with drugs that may cause NAFLD within 12 months prior to liver biopsy
• Treatment with some anti-diabetic medications; Unless started prior to biopsy (timeframe depending on drug) and stable

Sponsors & Collaborators

• Galmed Research and Development, Ltd.: lead

Study Sites (2)

The Public Health Trust of Miami-Dade County, Florida, dba the Jackson Health System

Miami, Florida, 33136, United States

Location

Texas Clinical Research Institute, LLC

Arlington, Texas, 76012, United States

Location

Related Publications (1)

• Ratziu V, Yilmaz Y, Lazas D, Friedman SL, Lackner C, Behling C, Cummings OW, Chen L, Petitjean M, Gilgun-Sherki Y, Gorfine T, Kadosh S, Eyal E, Sanyal AJ. Aramchol improves hepatic fibrosis in metabolic dysfunction-associated steatohepatitis: Results of multimodality assessment using both conventional and digital pathology. Hepatology. 2025 Mar 1;81(3):932-946. doi: 10.1097/HEP.0000000000000980. Epub 2024 Jun 25.

  PMID: 38916482 RESULT

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fibrosis; Liver Cirrhosis; Diabetes Mellitus; Obesity

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Results Point of Contact

• Title: Dr. Yossi Gilgun-Sherki
• Organization: Galmed Pharmaceuticals

yossigs@galmedpharma.com

0543314054

Study Officials

• Yossi Gilgun-Sherki, PhD, MBA

  Executive Drug Development Consultant

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In the Open Label part of the study, there will be a single group of 150 subjects (expected) all receiving Aramchol 300mg BID.

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 26, 2019
• Study Start: September 23, 2019
• Primary Completion: December 8, 2022
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 11, 2026
• Results First Posted: December 16, 2024

Record last verified: 2026-01

Locations

US (2)