Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion
Rohit Loomba, MD

Description

Summary

This is a Phase 2 multi-center, randomized, single-blind, placebo-controlled study to evaluate the safety and efficacy of TVB-2640 in subjects with non-alcoholic steatohepatitis (NASH), a type of fatty liver disease. Subjects will be randomly assigned to 1 of 2 treatment groups (TVB- 2640 at one of two doses or placebo). Following randomization, subjects will begin the 12-week treatment period and will receive once daily TVB-2640 or placebo.

Official Title

A Phase 2, Multi-Center, Single-Blind, Randomized, Placebo-Controlled Study of TVB 2640 in Subjects With Non-Alcoholic Steatohepatitis

Keywords

Non-Alcoholic Fatty Liver Disease NASH Non-Alcoholic Steatohepatitis Fatty Liver Disease Fatty Liver Liver Diseases FASN Fatty Acid Synthase Inhibitor TVB-2640

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Aged ≥ 18 years with a body mass index (BMI) ≤40 kg/m2.
  2. Prior liver biopsy within 24 months of randomization with fibrosis Stage 1 to 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:
  3. Steatosis
  4. Ballooning degeneration
  5. Lobular inflammation

AND

  • Confirmation of ≥ 8% liver fat content on MRI-PDFF.

OR, if prior biopsy is not available:

  • Either overweight or obese or diabetic or ALT ≥ 30 U/L or fatty liver on ultrasound and at least one more feature of metabolic syndrome by Adult Treatment Panel III (ATP III) criteria.

AND

  • Magnetic resonance elastography (MRE) ≥ 2.5 kPa and MRI-PDFF ≥ 8% during screening.

You CAN'T join if...

Subjects meeting any of the following criteria are not eligible for enrollment in the study.

  1. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening.

Note: Significant alcohol consumption is defined as average of > 20 g/day in female subjects and > 30 g/day in male subjects.

  1. Type 1 diabetes.
  2. Uncontrolled Type 2 diabetes defined as:
  3. HbA1c ≥ 9.5% during screening. (Subjects with HbA1c ≥ 9.5% may be rescreened).
  4. Basal insulin dose adjustment > 10% within 60 days prior to enrollment.
  5. Requirement for glucagon-like peptide analogue or a complex oral anti-diabetic (OAD) regimen (3 or more OADs) within 6 months of screening.
  6. History of severe hypoglycemia (symptomatic hypoglycemia requiring outside assistance to regain normal neurologic status) within the previous year.

Note: Individual diabetes regimens will be reviewed by Investigator and may be adjusted based on American Diabetes Association guidelines.

  1. Presence of cirrhosis on liver biopsy (Stage 4 fibrosis) or imaging.

Locations

  • University of California San Diego (UCSD) not yet accepting patients
    San Diego California 92037 United States
  • ProSciento accepting new patients
    Chula Vista California 91911 United States

Lead Scientist

  • Rohit Loomba, MD
    Adjunct Professor, Family Medicine and Public Health. Authored (or co-authored) 339 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
3V Biosciences, Inc.
ID
NCT03938246
Phase
Phase 2
Study Type
Interventional
Last Updated