A Phase 3/4 Clinical Study to Evaluate the Efficacy and Safety of Aramchol Versus Placebo in Subjects With NASH (ARMOR)

A Phase 3/4, Multinational, Multicenter, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With Nonalcoholic Steatohepatitis (NASH) The ARMOR Study

Sponsors

Lead Sponsor: Galmed Research and Development, Ltd.

Source Galmed Pharmaceuticals Ltd
Brief Summary

A double-blind placebo controlled randomized Phase 3/4 study in subjects with nonalcoholic steatohepatitis (NASH) and fibrosis stages 2-3 who are overweight or obese and have prediabetes or type 2 diabetes.

The primary objectives 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.

Overall Status Recruiting
Start Date September 23, 2019
Completion Date December 2024
Primary Completion Date June 2022
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
To evaluate the effect of Aramchol compared to placebo on liver histology by assessing the following primary endpoints: 52 weeks
To evaluate the effect of Aramchol compared to placebo on composite long-term outcome at End of Study, latest at 5 years from last subject's randomization
Enrollment 2000
Condition
Intervention

Intervention Type: Drug

Intervention Name: Aramchol

Description: Aramchol 300 mg BID

Arm Group Label: Aramchol

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo BID

Arm Group Label: Placebo

Eligibility

Criteria:

Key Inclusion Criteria:

1. Male or female age 18 to 75 years

2. 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)

3. 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)

4. Fibrosis Stage must be 2 or 3

5. Body mass index (BMI) between 25kg/m2 and 40 kg/m2

6. AST>20 IU/L

7. Type 2 diabetes mellitus or prediabetes

8. For subjects with type 2 diabetes, glycemia must be controlled

9. Females of childbearing potential must practice a highly effective method of contraception throughout the study period and for 1 month after treatment discontinuation.

10. Able to understand the nature of the study and to provide signature of the written informed consent.

Key Exclusion Criteria:

1. Histologically documented liver cirrhosis (fibrosis stage 4)

2. Inability or unwillingness to undergo a liver biopsy

3. Abnormal synthetic liver function

4. ALT or AST >5× upper limit of normal (ULN)

5. Platelet count < 150,000mm3

6. Alkaline phosphatase ≥2× ULN

7. Known or suspected hepatocellular carcinoma (HCC)

8. Model for End-Stage Liver Disease (MELD) score > 12

9. Prior history or presence of decompensated liver disease

10. Other (acute or chronic) coexisting liver disease based on medical history and/or centralized review of liver histology)

11. Known alcohol and/or any other drug abuse or dependence in the last five years

12. Weight loss of more than 5% within 3 months prior to screening

13. History of bariatric surgery within 5 years of liver biopsy or planned surgery for weight reduction

14. Treatment with drugs that may cause NAFLD within 12 months prior to liver biopsy

15. Treatment with some anti-diabetic medications; Unless started prior to biopsy (timeframe depending on drug) and stable

16. Current or planned treatment with immunosuppressive drugs

17. Evidence of any other unstable or untreated clinically significant disease

18. Uncontrolled hypertension

19. Any other condition that in the opinion of the Investigator warrants exclusion from the study

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Contact

Last Name: Galmed

Phone: +972-3-6938448

Email: [email protected]

Location
Facility: Status:
The Public Health Trust of Miami-Dade County, Florida, dba the Jackson Health System | Miami, Florida, 33136, United States Recruiting
Texas Clinical Research Institute, LLC | Arlington, Texas, 76012, United States Recruiting
Location Countries

United States

Verification Date

July 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Aramchol

Type: Experimental

Description: Aramchol 300 mg oral tablet

Label: Placebo

Type: Placebo Comparator

Description: Placebo matching oral tablet

Acronym ARMOR
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov