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A Study to Assess ARI-3037MO on Hepatic Fat Metabolism in Patients With Dysglycemia and Evidence of Hepatic Steatosis

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ClinicalTrials.gov Identifier: NCT02574325
Recruitment Status : Unknown
Verified October 2015 by Arisaph Pharmaceuticals Inc.
Recruitment status was:  Active, not recruiting
First Posted : October 12, 2015
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
Arisaph Pharmaceuticals Inc

Brief Summary:
Primary objective To investigate the effect of a 24-week, twice daily dosing regimen of ARI-3037MO compared to placebo on plasma triglyceride (TG) levels, liver enzymes and hepatic fat content in patients with dysglycemia and hepatic steatosis due to nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). Secondary Objective To investigate the safety and tolerability of a 24-week, twice daily dosing regimen of ARI-3037MO compared to placebo in patients with dysglycemia and evidence of NAFLD or NASH.

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis Drug: Placebo Drug: ARI-3037MO Phase 2

Detailed Description:

This randomized,double-blind, placebo-controlled study will enroll 36 men and women with a diagnosis of NAFLD orNASH. The study will be conducted over a period of approximately 28 wks and will include:a Screening Phase (Days -14to -1); a 24-week long Treatment Phase, during which patients will be randomly assigned to receive ARI-3037MO or placebo; an End-of-study Visit (ESV) scheduled 2 wks after the end of the Treatment Phase The Screening Phase will include 2 visits. Visit 1:There will be an initial assessment of a patient's eligibility for participation in the study. A complete medical history will be obtained and prospective study patients will undergo physical examinations and laboratory evaluations. For patients who have had a liver biopsy in the 6months prior to Visit 1, the histology findings, i.e., NAS, steatosis score and fibrosis score will be recorded. Visit 2:Approximately 1 week after Visit 1, and after the results of clinical laboratory screening test results have been reviewed by the Principal Investigator (PI), patients will be contacted to advise them of their eligibility to continue in the study. Eligible patients will undergo liver magnetic resonance imaging (MRI) to assess intrahepatic fat content. Treatment Phase Patients with MRI results showing intrahepatic fat content of ≥10% will be entered into the Treatment Phase of the study. The Treatment Phase will include 4 outpatient visits over a period of 24 weeks. Visit 3:Patients will be randomly assigned to receive ARI-3037MO or placebo on Day 1 of a 24-week long outpatient treatment period. Baseline assessments, including FibroTest®, FibroScan® and clinical laboratory tests, will be performed, and patients will take study drug twice daily. Visits 4, 5 and 6: During the Treatment Phase, patients will visit the study clinic at 4, 12 and 24 weeks (± 4 days) after Day 1 for evaluations and examinations and to collect study drug. Twenty-four weeks after the start of dosing, at the end of the Treatment Phase, patients will undergo a follow-up MRI and FibroScan† to assess change from baseline in intrahepatic fat content and liver fibrosis, respectively.

†If FibroScan equipment is available at the study site End-of-Study Visit Visit 7:An ESV will occur 2 weeks (± 4 days) after the end of the Treatment Phase.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Control

Experimental: ARI-3037MO
ARI-3037MO
Drug: ARI-3037MO
Treatment




Primary Outcome Measures :
  1. Efficacy as measured by change in intra hepatic fat content [ Time Frame: 24 wks ]
    Change in intra hepatic fat content by MRI

  2. Efficacy as measured by change in plasma ALT levels [ Time Frame: 24 wks ]
    Change in plasma ALT levels from baseline

  3. Efficacy as measured by change in plasma TG levels [ Time Frame: 24 wks ]
    Change in plasma TG levels from baseline


Secondary Outcome Measures :
  1. Safety as measured by the occurrence of flushing (number of episodes) and itching (number of episodes) [ Time Frame: 24 wks ]
    Occurrence of cutaneous symptoms

  2. Safety as measured by effect of ARI-3037MO on on glycemic control [ Time Frame: 24 wks ]
    Change in HbA1c levels from baseline

  3. Safety as measured by effect of ARI-3037MO on serum bilirubin, alkaline phosphatase, Prothrombin time and plasma albumin levels [ Time Frame: 24 wks ]
    Change of liver function tests from baseline

  4. Safety as measured by effect of ARI-3037MO on gastrointestinal systems; episodes of nausea, vomiting and diarrhea [ Time Frame: 24 wks ]
    occurrence of GI symptoms



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients ≥ 18 years of age at study entry
  2. Female patients must be of nonchildbearing potential
  3. Have a stable diet and agree to maintain this diet throughout the study
  4. Have not gained or lost ≥ 10 lbs (4.5 kg) of body weight within 6months prior to Screening Visit 1
  5. Have a body mass index (BMI) between 28 and 45 kg.m-2, inclusive
  6. Have elevated alanine aminotransferase (ALT) levels. For men: 50 IU/L to 250 IU/L, inclusive. For women: 40 IU/L to 240 IU/L, inclusive.
  7. Have HbA1c of < 9.5
  8. Have a intrahepatic fat content of ≥ 10% confirmed by liver MRI
  9. If taking antidiabetic therapies (excluding thiazolidines as per exclusion Criterion No. 13), i.e., metformin, sulfonylureas, dipeptidyl peptidase-4 inhibitors, insulin; must be on a stable dose for at least 3months prior to Screening Visit 1. Similarly, if taking lipid lowering therapies; must be on a stable dose for at least 3 months prior to Screening Visit 1.
  10. Understands the study requirements and the treatment procedures, is willing to comply with all protocol-required evaluations and provides written informed consent before any study specific tests or procedures are performed

Exclusion Criteria:

  1. A history of hepatic disease such as chronic hepatitis C virus or concurrent active hepatitis B virus (i.e., serum positive for hepatitis B surface antigen)
  2. Autoimmune hepatitis
  3. Primary biliary cirrhosis
  4. Sclerosing cholangitis
  5. Hereditary hemochromatosis
  6. History of chronic / repeat blood transfusion (i.e., ≥ 20 units of blood)
  7. Alpha-1 anti-trypsin deficiency
  8. Wilson's disease
  9. Thyroid disease
  10. Bariatric surgery within 5 years prior to Screening Visit 1
  11. Hepatic disease due to substance abuse
  12. Have any concurrent disease or condition not listed above that, in the opinion of the PI, would make the patient unsuitable for participation in the study
  13. Currently taking thiazolidines (glitazone therapy, i.e., Rosiglitazone, Pioglitazone)
  14. Liver biopsy in the past 90 days with negative results for cirrhosis and steatosis
  15. No evidence of hepatic decompensation or elevated serum bilirubin > 1.5 times the upper limit of normal
  16. Estimated glomerular filtration rate < 60 mL/min according to the Modification of Diet in Renal Disease equation
  17. Known substance abuse
  18. Current smoker or a history of smoking (> 10 cigarettes, > 3 cigars or > 3 pipes/day)
  19. Current consumption of > 3 units of alcohol per day (> 21 units per week) for men and > 2 units of alcohol per day (> 14 units per week) for women
  20. Currently participating in another clinical study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574325


Locations
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United States, Missouri
Gastroenterology & Hepatology CRU, St Louis University
St Louis, Missouri, United States, 63104
Sponsors and Collaborators
Arisaph Pharmaceuticals Inc

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Responsible Party: Arisaph Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT02574325     History of Changes
Other Study ID Numbers: ARI-3037MO-006
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: October 2015

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases