Montclair, California 91763

  • Alcoholic Fatty Liver Disease

Purpose:

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 three doses or placebo). Following randomization, subjects will begin the 12-week treatment period and will receive once daily TVB-2640 or placebo.


Criteria:

Inclusion Criteria: 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: - Steatosis - Ballooning degeneration - 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. Exclusion Criteria: 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. 2. Type 1 diabetes. 3. Uncontrolled Type 2 diabetes defined as: - HbA1c ≥ 9.5% during screening. (Subjects with HbA1c ≥ 9.5% may be rescreened). - Basal insulin dose adjustment > 10% within 60 days prior to enrollment. - Requirement for glucagon-like peptide analogue or a complex oral anti-diabetic (OAD) regimen (3 or more OADs) within 6 months of screening. - 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. 4. Presence of cirrhosis on liver biopsy (Stage 4 fibrosis) or imaging.


NCT ID:

NCT03938246


Primary Contact:

Principal Investigator
Rohit Loomba, MD
UCSD

Study Director: Sagimet Biosciences Inc.
Phone: 650-561-8675
Email: sitecontact@sagimet.com


Backup Contact:

N/A


Location Contact:

Montclair, California 91763
United States

Rizawana Mohseni

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 18, 2021

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