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Fatty Acid Synthase Inhibitor

TVB-2640 for Non-alcoholic Fatty Liver Disease

Phase 2
Waitlist Available
Research Sponsored by Sagimet Biosciences Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will study whether TVB-2640 is safe and effective in people with non-alcoholic steatohepatitis (NASH). Participants will be given the drug or a placebo pill to take once a day for 52 weeks.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Histological improvement in nonalcoholic fatty liver disease (NAFLD) activity score (NAS) without worsening of fibrosis (by NASH Clinical Research Network [CRN] fibrosis score) at Week 52
Resolution of steatohepatitis and no worsening of liver fibrosis (by NASH CRN fibrosis score).
Safety and tolerability of PO QD doses of TVB-2640 in subjects with confirmed NASH and liver fibrosis evaluated by incidence of treatment emergent adverse events (TEAEs)
Secondary outcome measures
Proportion of subjects who achieve a 30% reduction in liver fat content as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at Week 26.

Side effects data

From 2021 Phase 2 trial • 25 Patients • NCT03032484
78%
Palmar plantar erythrodysesthesia syndrome
65%
Mucositis
57%
Hypertension
52%
Dry Eye
30%
Fatigue
22%
Muscle weakness
22%
alopecia
22%
Skin infection
17%
Arthralgia
17%
Myalgia
13%
Allergic rhinitis
13%
Constipation
13%
Hoarseness
13%
Parestheisa
13%
Elevated ALT/AST
13%
Headache
13%
Depression
13%
Dysphasia
9%
Upper respiratory tract infection
9%
Urinary Tract Infection
9%
Cognitive Disturbance
9%
Conjunctivitis
9%
Diarrhea
9%
Dry Mouth
9%
Dry Skin
9%
Limb edema
9%
Hypokalemia
9%
Pruritis
4%
Acute kidney injury
4%
Anorexia
4%
Aphasia
4%
Bronchitis
4%
Confusion
4%
Increased Creatinine
4%
Thromboembolic event
4%
Vomiting
4%
Wound infection
4%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab and TVB-2640

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TVB-2640 50 mgExperimental Treatment1 Intervention
Subjects will receive TVB-2640 PO QD for 52 weeks, with the first dose administered on Day 1.
Group II: PlaceboPlacebo Group1 Intervention
Subjects will receive matching placebo PO QD for 52 weeks, with the first dose administered on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TVB-2640
2019
Completed Phase 2
~550

Find a Location

Who is running the clinical trial?

Sagimet Biosciences Inc.Lead Sponsor
7 Previous Clinical Trials
454 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
190 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

TVB-2640 (Fatty Acid Synthase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04906421 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: TVB-2640 50 mg, Placebo
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: TVB-2640 Highlights & Side Effects. Trial Name: NCT04906421 — Phase 2
TVB-2640 (Fatty Acid Synthase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04906421 — Phase 2
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT04906421 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many sites are currently administering this trial?

"Impact Research Institute in Waco, Texas, Jubilee Clinical Research Inc. in Las Vegas, Nevada and University of Gastroenterology in Providence Rhode island are among the 100 sites that form part of this clinical trial's infrastructure."

Answered by AI

Are there any opportunities to join this research initiative at present?

"According to clinicaltrials.gov, this experiment is no longer accepting volunteers at this time as it was last modified on September 30th 2022. Fortunately, there are 370 other medical trials currently recruiting participants."

Answered by AI

Does TVB-2640 pose health risks to those using it therapeutically?

"Data regarding TVB-2640's efficacy was limited, thus our team assigned a score of 2 reflecting the relative lack of clinical data supporting its safety."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Florida
Other
Texas
How old are they?
18 - 65
What site did they apply to?
Clinical Trials Research
Direct Helpers Research Center
Digestive Health Research of Southern California LLC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

Why did patients apply to this trial?

I'm interested in health improvement. My Dad died of liver cancer, I don't want to.
PatientReceived no prior treatments
IIn the past diagnosed with fatty liver perscibed pharmacy cod liver oil not taking it currently from 2008-2010.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

If I’m selected and I receive the medication and not the placebo how soon do lab tests show improvement?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH)
2021. "Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04906421.
~43 spots leftby May 2025
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