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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03938246
Recruitment Status : Completed
First Posted : May 6, 2019
Last Update Posted : October 29, 2021
Sponsor:
Information provided by (Responsible Party):
Sagimet Biosciences Inc.

Study Description
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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 three 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 Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Drug: TVB-2640 Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 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 22, 2019
Actual Primary Completion Date : October 2, 2021
Actual Study Completion Date : October 2, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Arms and Interventions
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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).
 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
Experimental: Cross over to TVB-2640
At Catalina Research Institute, a subset of subjects who received placebo in the single-blind Cohorts 1 and 2 at that site will be recruited to an open label cross over Cohort 3 where they will receive the study drug (TVB-2640 tablet) orally every day for 12-week treatment period. Additional patients from outside the pool of previous placebo subjects may be needed to meet the enrollment target.
 Drug: TVB-2640
Oral dose, tablet, daily dosing


Outcome Measures
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938246


Locations
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Sponsors and Collaborators
Sagimet Biosciences Inc.
Investigators
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Principal Investigator: Rohit Loomba, MD UCSD
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sagimet Biosciences Inc.
ClinicalTrials.gov Identifier: NCT03938246    
Other Study ID Numbers: 3V2640-CLIN-005
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: October 29, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Non-Alcoholic Steatohepatitis
Fatty Liver Disease
Fatty Liver
 Liver Diseases
FASN
Fatty Acid Synthase Inhibitor
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases