Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion
Principal Investigator
Rohit Loomba, MD (ucsd)
Photo of Rohit Loomba
Rohit Loomba

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 (FASCINATE-1)

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)
    San Diego California 92037 United States
  • ProSciento
    Chula Vista California 91911 United States
  • Clinical Trials Research
    Sacramento California 95821 United States

Lead Scientist at UC Health

  • Rohit Loomba, MD (ucsd)
    Adjunct Professor, Family Medicine And Public Health. Authored (or co-authored) 410 research publications.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sagimet Biosciences Inc.
ID
NCT03938246
Phase
Phase 2
Study Type
Interventional
Last Updated