A Study of the Efficacy and Safety of CF102 in the Treatment of Non-Alcoholic Fatty Liver Disease

NCT02927314 | Completed Phase 2

• 1 other identifier: CF102-211LD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in subjects with NAFLD and NASH.

Conditions

Non-alcoholic Steatohepatitis (NASH)

Outcome Measures

Primary Outcomes (2)

• Efficacy of CF102 as determined by change in serum alanine aminotransferase (ALT) levels

  Mean percent change in serum alanine aminotransferase (ALT) levels

  12 weeks

• Efficacy of CF102 as determined by change in magnetic resonance imaging-determined hepatic steatosis

  Percent change from Baseline in hepatic steatosis measured by magnetic resonance imaging-determined proton-density fat-fraction (MRI-PDFF)

  12 weeks

Secondary Outcomes (9)

• Body weight in subjects with NAFLD

  12 weeks

• Waist circumference in subjects with NAFLD

  12 weeks

• HDL cholesterol levels in subjects with NAFLD

  12 weeks

• Normalization of serum ALT levels in subjects with NAFLD

  12 weeks

• Serum aspartate aminotransaminase (AST) levels in subjects with NAFLD

  12 weeks

Other Outcomes (7)

• Serum adiponectin levels

  12 weeks

• Serum leptin levels

  12 weeks

• Serum alpha-2 macroglobulin levels

  12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo tablets orally q12h

Drug: Placebo

CF102 12.5mg

ACTIVE COMPARATOR

CF102 tablets orally q12h

Drug: CF102

CF102 25mg

ACTIVE COMPARATOR

CF102 tablets orally q12h

Drug: CF102

Interventions

CF102 DRUG

orally q12h

Also known as: Cl-IB-MECA

CF102 12.5mg; CF102 25mg

Placebo DRUG

orally q12h

Placebo

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age.
• Diagnosis of NAFLD by non-invasive determination of liver triglyceride concentration, as defined as triglyceride concentration ≥10.0% by NMRS.
• At least 2 of the following:
• Obesity, defined as body mass index (BMI) of ≥25 and ≤40 kg/m2; or waist circumference \>88 and \<200 cm for women or \>102 and \<200 cm for men
• Type II diabetes mellitus, defined by the criteria of the American Diabetes Association (Appendix 1)
• Blood pressure of 130/85 or higher (either systolic or diastolic)
• Hypertriglyceridemia, defined as \>150 mg/dL (\>1.7 mmol/L)
• Reduced high-density lipoprotein (HDL) cholesterol, defined as \<40 mg/dL (\<1.04 mmol/L) in men or \<50 mg/dL (\<1.3 mmol/L) in women.
• Acceptable hepatic metabolic and synthetic function, as indicated at Screening by:
• Serum albumin ≥3.5 gm/dL
• INR ≤1.2
• Serum total bilirubin ≤2.0 mg/dL.
• Absence of cirrhosis, defined as a Fibroscan score of ≤F4 and liver stiffness measurement (LSM) of 7 13 kPa.
• The following laboratory values must be documented at Screening prior to initiation of study drug:
• Absolute neutrophil count \>1.5x109/L

You may not qualify if:

• Presence of ascites, hepatic encephalopathy, or other clinical evidence of cirrhosis.
• Other active acute or chronic liver disease, such as autoimmune hepatitis, hepatitis B, hepatitis C, alcoholic liver disease, or hepatocellular carcinoma at the time of Screening and randomization.
• Familial dyslipidemia.
• Weight loss of \>5% within 6 months prior to Baseline.
• History of bariatric surgery within 5 years of Screening.
• Diabetes mellitus other than Type II.
• Daily alcohol intake \>20 g/day for women and 30 g/day for men (on average per day), as per medical history.
• Treatment with the following anti-diabetic medications: DPP-4 inhibitor unless it was stopped 3 months before Screening, GLP-1 receptor agonists (such as Januvia \[sitagliptin\], Byetta \[incretin\], etc.) unless it was started at least 12 months and on stable dose at least 3 months prior to Screening.
• Metformin, fibrates, statins, insulin, or sulfonylurea unless the dose has been stabilized for the last 1 month prior to Screening.
• More than 7 days of treatment with valproic acid, tamoxifen, methotrexate, amiodarone, rifaximin, other antibiotics, or anti-cholinergic agents within 3 months prior to Screening.
• Uncontrolled or clinically unstable thyroid disease, in the judgment of the Principal Investigator.
• Seropositivity for markers of viral hepatitis or human immunodeficiency virus (HIV) at Screening.
• Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4).
• Angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.
• History of or ongoing cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the QTc (Fridericia) interval to \>450 msec for males or \>470 msec for females.

Sponsors & Collaborators

• Can-Fite BioPharma: lead

Study Sites (3)

Can-Fite Investigational Site #318

Jerusalem, Israel

Location

Can-Fite Investigational Site #319

Nazareth, Israel

Location

Can-Fite Investigational Site #311

Petah Tikva, Israel

Location

Related Publications (2)

• Muthiah MD, Siddiqui MS. Editorial: targeting aberrant hepatic inflammation for treatment of non-alcoholic steatohepatitis. Aliment Pharmacol Ther. 2022 Feb;55(4):483-484. doi: 10.1111/apt.16748. No abstract available.

  PMID: 35092056 DERIVED

• Safadi R, Braun M, Francis A, Milgrom Y, Massarwa M, Hakimian D, Hazou W, Issachar A, Harpaz Z, Farbstein M, Itzhak I, Lev-Cohain N, Bareket-Samish A, Silverman MH, Fishman P. Randomised clinical trial: A phase 2 double-blind study of namodenoson in non-alcoholic fatty liver disease and steatohepatitis. Aliment Pharmacol Ther. 2021 Dec;54(11-12):1405-1415. doi: 10.1111/apt.16664. Epub 2021 Oct 20.

  PMID: 34671996 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

2-chloro-N(6)-(3-iodobenzyl)adenosine-5'-N-methyluronamide

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Michael H Silverman, MD

  Can-Fite BioPharma Ltd

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 25, 2016
• First Posted: October 7, 2016
• Study Start: November 27, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

IL (3)