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

NCT02574325 | Unknown Phase 2

• 1 other identifier: ARI-3037MO-006
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (3)

• Efficacy as measured by change in intra hepatic fat content

  Change in intra hepatic fat content by MRI

  24 wks

• Efficacy as measured by change in plasma ALT levels

  Change in plasma ALT levels from baseline

  24 wks

• Efficacy as measured by change in plasma TG levels

  Change in plasma TG levels from baseline

  24 wks

Secondary Outcomes (4)

• Safety as measured by the occurrence of flushing (number of episodes) and itching (number of episodes)

  24 wks

• Safety as measured by effect of ARI-3037MO on on glycemic control

  24 wks

• Safety as measured by effect of ARI-3037MO on serum bilirubin, alkaline phosphatase, Prothrombin time and plasma albumin levels

  24 wks

• Safety as measured by effect of ARI-3037MO on gastrointestinal systems; episodes of nausea, vomiting and diarrhea

  24 wks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

ARI-3037MO

EXPERIMENTAL

ARI-3037MO

Drug: ARI-3037MO

Interventions

Placebo DRUG

Control

Placebo

ARI-3037MO DRUG

Treatment

ARI-3037MO

Eligibility Criteria

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

You may qualify if:

• Male and female patients ≥ 18 years of age at study entry
• Female patients must be of nonchildbearing potential
• Have a stable diet and agree to maintain this diet throughout the study
• Have not gained or lost ≥ 10 lbs (4.5 kg) of body weight within 6months prior to Screening Visit 1
• Have a body mass index (BMI) between 28 and 45 kg.m-2, inclusive
• 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.
• Have HbA1c of \< 9.5
• Have a intrahepatic fat content of ≥ 10% confirmed by liver MRI
• 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

You may not qualify if:

• 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)
• Autoimmune hepatitis
• Primary biliary cirrhosis
• Sclerosing cholangitis
• Hereditary hemochromatosis
• History of chronic / repeat blood transfusion (i.e., ≥ 20 units of blood)
• Alpha-1 anti-trypsin deficiency
• Wilson's disease
• Thyroid disease
• Bariatric surgery within 5 years prior to Screening Visit 1
• Hepatic disease due to substance abuse
• 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
• Currently taking thiazolidines (glitazone therapy, i.e., Rosiglitazone, Pioglitazone)
• Liver biopsy in the past 90 days with negative results for cirrhosis and steatosis
• No evidence of hepatic decompensation or elevated serum bilirubin \> 1.5 times the upper limit of normal

Sponsors & Collaborators

• Arisaph Pharmaceuticals Inc: lead

Study Sites (1)

Gastroenterology & Hepatology CRU, St Louis University

St Louis, Missouri, 63104, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 12, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 8, 2016

Record last verified: 2015-10

Locations

US (1)