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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Study of TVB 2640 in Subjects With Non-Alcoholic Steatohepatitis (NASH)

Clinicaltrials.gov identifier NCT03938246

Recruitment Status Active, not recruiting

First Posted May 6, 2019

Last update posted March 24, 2021

Study Description

Brief 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.

  • Condition or Disease:Non-Alcoholic Fatty Liver Disease
  • Intervention/Treatment: Drug: TVB-2640
    Other: Placebo
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 129 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Subjects will be randomly assigned to experimental or placebo arms.
  • Masking: Single (Participant)
  • Primary Purpose: Treatment
  • Official Title: A Phase 2, Multi-Center, Single-Blind, Randomized, Placebo-Controlled Study of TVB 2640 in Subjects With Non-Alcoholic Steatohepatitis (FASCINATE-1)
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: August 2021
  • Estimated Study Completion Date: September 2021
Arms and interventions
Arm Intervention/treatment
Experimental: TVB-2640
Subjects randomly assigned to receive the study drug will take TVB-2640 tablet orally every day for 12 week treatment period. The dose is to be taken at the same time of the day, with each dose separated by 24 hours (±4 hours). Two dose cohorts of TVB-2640 are planned.
Drug: TVB-2640
Oral dose, tablet, daily dosing
Placebo Comparator: Placebo
Subjects randomly assigned to placebo will receive placebo tablets orally once a day under the same conditions and frequency as described for TVB-2640.
Other: Placebo
Oral dose, tablet, daily dosing
Outcome Measures
  • Primary Outcome Measures: 1. The effect of TVB-2640 versus placebo on the change in hepatic fat fraction from baseline in subjects with NASH by proton-density fat fraction by magnetic resonance imaging. [ Time Frame: 12 weeks ]
    Proton-density Fat Fraction by Magnetic Resonance Imaging
  • 2. The safety of TVB-2640 versus placebo in subjects with NASH, including changes in liver enzymes by monitoring adverse events. [ Time Frame: 12 weeks ]
  • Secondary Outcome Measures: 1. The effect of TVB-2640 versus placebo on the change in triglycerides from baseline in subjects with NASH. [ Time Frame: 12 weeks ]
  • 2. The effect of TVB-2640 versus placebo on the change in low-density lipoprotein cholesterol (LDL-C) from baseline in subjects with NASH. [ Time Frame: 12 weeks ]
  • 3. The effect of TVB-2640 versus placebo on the change in high-density lipoprotein cholesterol (HDL-C) from baseline in subjects with NASH. [ Time Frame: 12 weeks ]
  • 4. The effect of TVB-2640 versus placebo on the change in total cholesterol from baseline in subjects with NASH. [ Time Frame: 12 weeks ]
  • 5. The effect of TVB-2640 versus placebo on the change in NASH and cytokeratin-18 (CK-18) from baseline in subjects with NASH. [ Time Frame: 12 weeks ]
  • 6. The effect of TVB-2640 versus placebo on the change in NASH and fibrosis-4 (FIB-4) from baseline in subjects with NASH. [ Time Frame: 12 weeks ]
  • 7. The effect of TVB-2640 versus placebo on the change in NASH and enhanced liver fibrosis score (ELF) from baseline in subjects with NASH. [ Time Frame: 12 weeks ]
    The Enhanced Liver Fibrosis (ELF) score is a marker set consisting of tissue inhibitor of metalloproteinases 1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP) and hyaluronic acid (HA) showing good correlations with fibrosis stages in chronic liver disease. There are three typical cut-off values: < 7.7 for exclusion of fibrosis, 9.8 for a high specificity identification of fibrosis and 11.3 to discriminate cirrhosis.
  • 8. The effect of TVB-2640 versus placebo on the change in levels of eicosanoids from baseline in subjects with NASH. [ Time Frame: 12 weeks ]
    Eicosanoids are lipid-derived signaling molecules including 5-LOX-derived leukotriene B4 (LTB4), COX-derived prostaglandin E2 (PGE2), and 15-LOX-derived 15-hydroxyeicosatetraenoic acid (15-HETE) and lipoxin A4 (LXA4).
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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.

Contacts and Locations
Contacts
Locations
Show 23 Study Locations
Sponsors and Collaborators

Sagimet Biosciences Inc.

Investigators

Principal Investigator: Rohit Loomba, MD UCSD

More Information
  • Responsible Party: Sagimet Biosciences Inc.
  • ClinicalTrials.gov Identifier: NCT03938246 History of Changes
  • Other Study ID Numbers: 3V2640-CLIN-005
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: March 24, 2021
  • Last Verified: March 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Sagimet Biosciences Inc.: NASH
    Liver Diseases
    FASN
    Fatty Liver
    Fatty Liver Disease
    Non-Alcoholic Steatohepatitis
    Fatty Acid Synthase Inhibitor
  • Additional relevant MeSH terms: Fatty Liver
    Liver Diseases
    Non-alcoholic Fatty Liver Disease