Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH)
A Phase 2B, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (FASCINATE-2)
1 other identifier
interventional
168
4 countries
117
Brief Summary
This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy on TVB-2640 in subjects with non-alcoholic steatohepatitis (NASH). Subjects will be randomly assigned toTVB-2640 or matching placebo PO QD for 52 weeks, with the first dose administered on Day 1.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2021
117 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2021
CompletedFirst Posted
Study publicly available on registry
May 28, 2021
CompletedStudy Start
First participant enrolled
August 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2023
CompletedResults Posted
Study results publicly available
May 9, 2025
CompletedMay 9, 2025
April 1, 2025
2.1 years
May 20, 2021
April 28, 2025
April 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) Without Worsening of Fibrosis (by NASH Clinical Research Network [CRN] Fibrosis Score).
Histological improvement is defined as ≥2 points improvement in NAS with ≥1 point improvement in ballooning or inflammation
52 Weeks
Subjects With Resolution of Steatohepatitis and No Worsening of Liver Fibrosis by NASH CRN Fibrosis Score and Histological Improvement in NAS.
NASH resolution defined as absence of fatty liver disease or isolated or simple steatosis without steatohepatitis and a score of either 0 or 1 for inflammation, 0 for ballooning and any value for steatosis and no worsening of liver fibrosis (by NASH CRN fibrosis score). Histological improvement defined as ≥2 point improvement in NAS (with ≥1 point improvement in ballooning or inflammation).
52 Weeks
Secondary Outcomes (4)
Proportion of Subjects Experiencing Fibrosis Improvement of ≥1 Stage by NASH CRN Score Without Worsening of Steatohepatitis
52 Weeks
Proportion of Subjects Experiencing Resolution of Steatohepatitis and no Worsening of Liver Fibrosis (by NASH CRN Fibrosis Score)
52 Weeks
Proportion of Subjects With Improvement in Liver Fibrosis >=1 Stage by NASH CRN Fibrosis Score Without Worsening of Steatohepatitis at 52 Weeks OR Resolution of Steatohepatitis and No Worsening of Liver Fibrosis by NASH CRN Fibrosis Score
52 Weeks
Proportion of MRI-PDFF ≥30% Responders.
52 Weeks
Study Arms (2)
TVB-2640 50 mg
EXPERIMENTALSubjects will receive TVB-2640 PO QD for 52 weeks, with the first dose administered on Day 1.
Placebo
PLACEBO COMPARATORSubjects will receive matching placebo PO QD for 52 weeks, with the first dose administered on Day 1.
Interventions
Eligibility Criteria
You may qualify if:
- Must be willing and able to participate in the study and provide written informed consent.
- Male and female adults ≥18 years of age on the date that written informed consent to take part in the study is provided.
- Body mass index (BMI) ≥23 kg/m2 for Asians and ≥25 kg/m2 for other races.
- Female subjects must be either:
- Not of childbearing potential OR
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy (beta-human chorionic gonadotropin \[β-HCG\]) test during Screening, a negative urine pregnancy test within 24 hours before the first dose of study drug on Day 1, and must agree to perform urine home pregnancy tests monthly between study visits. WOCBP must not be breastfeeding, not plan to become pregnant during the study, and must use birth control.
- Must have liver stiffness measurement ≥8.5 kPa measured by FibroScan and CAP score measured by FibroScan ≥280 dB/m during the Screening period.
- Histologic confirmation of NASH: must have had prior liver biopsy within 180 days before randomization (randomization is within 24 hours of Baseline \[Day1\]) with fibrosis stage F2-F3 and a NAS of ≥4 with at least a score of 1 in each of the following NAS components: steatosis, ballooning degeneration, and lobular inflammation.
You may not qualify if:
- History of harmful alcohol intake for a period of more than 3 consecutive months within 1 year prior to Screening in the judgement of the Investigator.
- Active substance abuse.
- Gain or loss of \>5% of body weight in the 6 months prior to Baseline (Day 1) or \>10% of body weight in the 12 months prior to Screening.
- Type 1 diabetes mellitus by history.
- Uncontrolled T2DM, defined as HbA1c ≥9.5% at Screening.
- Presence of cirrhosis on liver histology (stage 4 fibrosis), according to the judgement of the central reader, and/or cross sectional imaging evidence consistent with cirrhosis and/or portal hypertension.
- Use of glucagon-like peptide-1 (GLP-1) agonists or a sodium-glucose co-transporter-2 (SGLT2) inhibitor, unless on a stable daily dose for at least 6 months prior to the Screening visit date, or on a complex oral anti-diabetic (OAD) regimen (3 or more OADs \[except for a GLP-1 agonist or an SGLT2 inhibitor\]), unless on a stable dose for at least 3 months prior to the Screening visit date.
- Subjects with active or quiescent chronic liver disease of etiologies other than NASH (eg, viral or autoimmune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, and 'autoimmune hepatitis-overlap' syndromes, hemochromatosis, Wilson's disease, alpha 1 antitrypsin deficiency, alcohol-related liver disease, drug-induced liver disease, and/or infiltrative conditions \[eg, sarcoidosis\]).
- Current or historic clinically evident hepatic decompensation event (eg, ascites formation, variceal hemorrhage, hepatic encephalopathy).
- Any subject who has sustained a clinically evident cardiovascular, cerebrovascular, and/or peripheral vascular event during the 12 months prior to anticipated Baseline (Day 1) visit date is not eligible for study participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (117)
North Alabama Health Research
Huntsville, Alabama, 35801, United States
North Alabama GI Research Center
Madison, Alabama, 35758, United States
GI Alliance Arizona Digestive Health-Sun City
Sun City, Arizona, 85351, United States
ARcare Center for Clinical Research, LLC - Conway
Conway, Arkansas, 72032, United States
Arkansas Diagnostic Center
Little Rock, Arkansas, 72205, United States
Liver Wellness Center
Little Rock, Arkansas, 72205, United States
Citrus Valley Gastroenterology
Covina, California, 91723, United States
UCSD, NAFLD Research Center / Altman Clinical and Translational Research Institute
La Jolla, California, 92093, United States
Om Research LLC
Lancaster, California, 93534, United States
Clinical Trials Research
Lincoln, California, 95648, United States
Digestive Health Research of Southern California LLC
Long Beach, California, 90808, United States
Digestive Health Research of Southern California
Long Beach, California, 90808, United States
Catalina Research Institute, LLC
Montclair, California, 91763, United States
United Medical Doctors
Murrieta, California, 92563, United States
Palmtree Clinical Research, INC
Palm Springs, California, 92262, United States
IVGI
Ventura, California, 93003, United States
Gastro Florida
Clearwater, Florida, 33761, United States
Tampa Bay Medical Research, Inc.
Clearwater, Florida, 33761, United States
American Research Institute, Inc
Cutler Bay, Florida, 33157, United States
Top Medical Research, Inc
Cutler Bay, Florida, 33189, United States
Covenant Metabolic Specialists, LLC
Fort Myers, Florida, 33912, United States
Direct Helpers Research Center
Hialeah, Florida, 33012, United States
Miguel A Rebollar, MD PA
Hialeah, Florida, 33012, United States
Global Research Associates
Homestead, Florida, 33030, United States
Ocala GI Research dba Lake Center for Clinical Research, LLC
Lady Lake, Florida, 32159, United States
Accel Research Site - Maitland
Maitland, Florida, 32751, United States
CPMI
Miami, Florida, 33014, United States
University of Miami
Miami, Florida, 33136, United States
Sanchez Clinical Research, Inc
Miami, Florida, 33157, United States
Genoma Research Group, Inc
Miami, Florida, 33173, United States
Panax Clinical Research
Miami Lakes, Florida, 33014, United States
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, 33014, United States
Professional Medical Research
Miramar, Florida, 33025, United States
Ocala GI Research, LLC
Ocala, Florida, 34471, United States
Innovation Medical Research Center, Inc
Palmetto Bay, Florida, 33157, United States
Pensacola GI Research Center, LLC
Pensacola, Florida, 32503, United States
Covenant Metabolic Specialists, LLC
Sarasota, Florida, 34240, United States
Headlands Research Sarasota
Sarasota, Florida, 34243, United States
Conquest Research
Winter Park, Florida, 32789, United States
Summit Clinical Research
Athens, Georgia, 30607, United States
Southeast Clinical Research Center
Dalton, Georgia, 30720, United States
Care Access Research
Fairview Heights, Illinois, 62208, United States
Gastroenterology Health Partners, PLLC
New Albany, Indiana, 47150, United States
Digestive Research Alliance of Michiana
South Bend, Indiana, 46635, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Kansas Medical Clinic, PA
Topeka, Kansas, 66606, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Louisiana Research Center LLC
Shreveport, Louisiana, 71105, United States
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, 21061, United States
Greater Boston Gastroenterology
Boston, Massachusetts, 01702, United States
Greater Boston Gastroenterology
Framingham, Massachusetts, 01702, United States
FC Research LLC
South Dartmouth, Massachusetts, 02747, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
GI Associates Research, LLC
Columbia, Missouri, 65201, United States
Sierra Clinical Research
Las Vegas, Nevada, 89106, United States
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, 899106, United States
Care Access
Yonkers, New York, 10701, United States
University of North Carolina at Chapel Hill. UNC Liver Center
Chapel Hill, North Carolina, 27599, United States
Northeast GI Research Division
Concord, North Carolina, 28027, United States
ACME Medical Specialties PLCC
Lumberton, North Carolina, 28358, United States
Care Access Research
Lumberton, North Carolina, 28358, United States
Lucas Research, Inc.
Morehead City, North Carolina, 28557, United States
Trial Management Associates, LLC
Wilmington, North Carolina, 28403, United States
Ohio State University
Columbus, Ohio, 43210, United States
DSI Research, LLC - Northridge
Dayton, Ohio, 45414, United States
Care Access Research
Poland, Ohio, 44514, United States
DDSI Clinical Trials
Oklahoma City, Oklahoma, 73112, United States
University of Gastroenterology
Providence, Rhode Island, 02905, United States
Care Access Research
Warwick, Rhode Island, 02886, United States
Ralph H. Johnson Veterans Affairs Medical Center
Charleston, South Carolina, 29401, United States
Columbia Digestive Health Research, LLC
Columbia, South Carolina, 29204, United States
Digestive Disease Research Center LLC
Greenwood, South Carolina, 29646, United States
Rapid City Medical Center, LLP
Rapid City, South Dakota, 57701, United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
Gastro One
Cordova, Tennessee, 38018, United States
Gastro One
Germantown, Tennessee, 38138, United States
Digestive Health Research
Lebanon, Tennessee, 37090, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012, United States
Pinnacle Clinical Research
Austin, Texas, 78557, United States
Apex Mobile Clinical Research, LLC
Bellaire, Texas, 77401, United States
Texas Digestive Disease Consultants - Cedar Park
Cedar Park, Texas, 78613, United States
The Liver Institute at Methodist Health System
Dallas, Texas, 75203, United States
GI Alliance -Texas Digestive Disease Consultants
Dallas, Texas, 75246, United States
South Texas Research Institute
Edinburg, Texas, 78539, United States
Texas Digestive Disease Consultants - Fort Worth
Fort Worth, Texas, 76104, United States
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, 77030, United States
Pioneer Research Solutions
Houston, Texas, 77099, United States
GI Alliance / Texas Digestive Disease Consultants
Lubbock, Texas, 79410, United States
Centex Studies
McAllen, Texas, 78504, United States
ClinRx Research LLC
Plano, Texas, 75023, United States
American Research Corporation
San Antonio, Texas, 78215, United States
Clinical Trials of Texas Inc.
San Antonio, Texas, 78229, United States
Diabetes and Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229, United States
Endeavor Clinical Trials, LLC
San Antonio, Texas, 78229, United States
Pinnacle Clinical Research
San Antonio, Texas, 78240, United States
Sherman Clinical Research
Sherman, Texas, 75092, United States
Impact Research Institute
Waco, Texas, 76710, United States
Digestive Health Research of North Texas
Wichita Falls, Texas, 76301, United States
Care Access
Ogden, Utah, 84403, United States
Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond
Richmond, Virginia, 23226, United States
GI Select Health Research, LLC
Richmond, Virginia, 23236, United States
McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Gastroenterology Consultants of SW Virginia
Roanoke, Virginia, 24014, United States
University of Calgary Liver Unit
Calgary, Alberta, T2N 4Z6, Canada
GI Research Institute
Vancouver, British Columbia, V6Z 2K5, Canada
Office of Dr. Gauthier
North Bay, Ontario, P1B 2H3, Canada
Toronto Liver Centre
Toronto, Ontario, M6H 3M1, Canada
Office of Dr. Gauthier
Toronto, Ontario, M6H-3M1, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Centrum Medyczne Pratia
Katowice, 40-081, Poland
Krakowskie Centrum Medyczne sp z o.o.
Krakow, 31-501, Poland
Hepatology Outpatient Clinic
Śląskie, 41-400, Poland
ID Clinic Arkadiusz Pisula
Śląskie, 41-400, Poland
Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728, Poland
Centrum Medyczne K2J2
Wołomin, 05-200, Poland
FutureMeds
Wroclaw, 50-088, Poland
FDI Clinical Research
San Juan, 00927, Puerto Rico
Related Publications (1)
Loomba R, Bedossa P, Grimmer K, Kemble G, Bruno Martins E, McCulloch W, O'Farrell M, Tsai WW, Cobiella J, Lawitz E, Rudraraju M, Harrison SA. Denifanstat for the treatment of metabolic dysfunction-associated steatohepatitis: a multicentre, double-blind, randomised, placebo-controlled, phase 2b trial. Lancet Gastroenterol Hepatol. 2024 Dec;9(12):1090-1100. doi: 10.1016/S2468-1253(24)00246-2. Epub 2024 Oct 11.
PMID: 39396529BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Results Point of Contact
- Title
- Study Director
- Organization
- Sagimet Biosciences, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2021
First Posted
May 28, 2021
Study Start
August 12, 2021
Primary Completion
October 2, 2023
Study Completion
October 2, 2023
Last Updated
May 9, 2025
Results First Posted
May 9, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share