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Metabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver DiseasePhase 2NCT04906421

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

A Phase 2 study testing TVB-2640 in people with Metabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver Disease, run by Sagimet Biosciences Inc. at 117 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TVB-2640
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
168 participants
Where
117 sitesin 4 countries
Study dates
12 Aug 2021to 2 Oct 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • Positive severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) polymerase chain reaction (PCR) test within 30 days before Baseline, history of hospitalization for coronavirus disease-2019 (COVID-19) ), or history of use of oxygen due to COVID-19) <6 months prior to the Screening visit date. Note that previous COVID-19 infection alone is not exclusionary and vaccination against SARS-CoV-2 is allowed. Infection and/or vaccination must be documented.
  • Uncontrolled T2DM, defined as HbA1c ≥9.5% at Screening.
Show all 11Show fewer
  • 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.

Trial locations and contacts

117 sites in 4 countries.

117 sites in 4 countries

United States103 sites

  • Texas Clinical Research Institute, LLC

    Arlington, Texas, 76012

  • Summit Clinical Research

    Athens, Georgia, 30607

  • Pinnacle Clinical Research

    Austin, Texas, 78557

  • Apex Mobile Clinical Research, LLC

    Bellaire, Texas, 77401

  • Greater Boston Gastroenterology

    Boston, Massachusetts, 01702

  • Texas Digestive Disease Consultants - Cedar Park

    Cedar Park, Texas, 78613

  • University of North Carolina at Chapel Hill. UNC Liver Center

    Chapel Hill, North Carolina, 27599

  • Ralph H. Johnson Veterans Affairs Medical Center

    Charleston, South Carolina, 29401

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Gastro Florida

    Clearwater, Florida, 33761

  • Tampa Bay Medical Research, Inc.

    Clearwater, Florida, 33761

  • GI Associates Research, LLC

    Columbia, Missouri, 65201

  • Columbia Digestive Health Research, LLC

    Columbia, South Carolina, 29204

  • Ohio State University

    Columbus, Ohio, 43210

  • Northeast GI Research Division

    Concord, North Carolina, 28027

  • ARcare Center for Clinical Research, LLC - Conway

    Conway, Arkansas, 72032

  • Gastro One

    Cordova, Tennessee, 38018

  • Citrus Valley Gastroenterology

    Covina, California, 91723

  • American Research Institute, Inc

    Cutler Bay, Florida, 33157

  • Top Medical Research, Inc

    Cutler Bay, Florida, 33189

  • The Liver Institute at Methodist Health System

    Dallas, Texas, 75203

  • GI Alliance -Texas Digestive Disease Consultants

    Dallas, Texas, 75246

  • Southeast Clinical Research Center

    Dalton, Georgia, 30720

  • DSI Research, LLC - Northridge

    Dayton, Ohio, 45414

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • South Texas Research Institute

    Edinburg, Texas, 78539

  • Care Access Research

    Fairview Heights, Illinois, 62208

  • Covenant Metabolic Specialists, LLC

    Fort Myers, Florida, 33912

  • Texas Digestive Disease Consultants - Fort Worth

    Fort Worth, Texas, 76104

  • Greater Boston Gastroenterology

    Framingham, Massachusetts, 01702

  • Gastro One

    Germantown, Tennessee, 38138

  • Woodholme Gastroenterology Associates

    Glen Burnie, Maryland, 21061

  • Digestive Disease Research Center LLC

    Greenwood, South Carolina, 29646

  • Direct Helpers Research Center

    Hialeah, Florida, 33012

  • Miguel A Rebollar, MD PA

    Hialeah, Florida, 33012

  • Global Research Associates

    Homestead, Florida, 33030

  • Baylor College of Medicine - Advanced Liver Therapies

    Houston, Texas, 77030

  • Pioneer Research Solutions

    Houston, Texas, 77099

  • North Alabama Health Research

    Huntsville, Alabama, 35801

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • UCSD, NAFLD Research Center / Altman Clinical and Translational Research Institute

    La Jolla, California, 92093

  • Ocala GI Research dba Lake Center for Clinical Research, LLC

    Lady Lake, Florida, 32159

  • Om Research LLC

    Lancaster, California, 93534

  • Sierra Clinical Research

    Las Vegas, Nevada, 89106

  • Jubilee Clinical Research, Inc.

    Las Vegas, Nevada, 899106

  • Digestive Health Research

    Lebanon, Tennessee, 37090

  • Clinical Trials Research

    Lincoln, California, 95648

  • Arkansas Diagnostic Center

    Little Rock, Arkansas, 72205

  • Liver Wellness Center

    Little Rock, Arkansas, 72205

  • Digestive Health Research of Southern California LLC

    Long Beach, California, 90808

  • Digestive Health Research of Southern California

    Long Beach, California, 90808

  • GI Alliance / Texas Digestive Disease Consultants

    Lubbock, Texas, 79410

  • ACME Medical Specialties PLCC

    Lumberton, North Carolina, 28358

  • Care Access Research

    Lumberton, North Carolina, 28358

  • North Alabama GI Research Center

    Madison, Alabama, 35758

  • Accel Research Site - Maitland

    Maitland, Florida, 32751

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • Centex Studies

    McAllen, Texas, 78504

  • CPMI

    Miami, Florida, 33014

  • University of Miami

    Miami, Florida, 33136

  • Sanchez Clinical Research, Inc

    Miami, Florida, 33157

  • Genoma Research Group, Inc

    Miami, Florida, 33173

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

  • San Marcus Research Clinic, Inc.

    Miami Lakes, Florida, 33014

  • Professional Medical Research

    Miramar, Florida, 33025

  • Catalina Research Institute, LLC

    Montclair, California, 91763

  • Lucas Research, Inc.

    Morehead City, North Carolina, 28557

  • United Medical Doctors

    Murrieta, California, 92563

  • Gastroenterology Health Partners, PLLC

    New Albany, Indiana, 47150

  • Ocala GI Research, LLC

    Ocala, Florida, 34471

  • Care Access

    Ogden, Utah, 84403

  • DDSI Clinical Trials

    Oklahoma City, Oklahoma, 73112

  • Palmtree Clinical Research, INC

    Palm Springs, California, 92262

  • Innovation Medical Research Center, Inc

    Palmetto Bay, Florida, 33157

  • Pensacola GI Research Center, LLC

    Pensacola, Florida, 32503

  • ClinRx Research LLC

    Plano, Texas, 75023

  • Care Access Research

    Poland, Ohio, 44514

  • University of Gastroenterology

    Providence, Rhode Island, 02905

  • Rapid City Medical Center, LLP

    Rapid City, South Dakota, 57701

  • Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond

    Richmond, Virginia, 23226

  • GI Select Health Research, LLC

    Richmond, Virginia, 23236

  • McGuire VA Medical Center

    Richmond, Virginia, 23249

  • Gastroenterology Consultants of SW Virginia

    Roanoke, Virginia, 24014

  • American Research Corporation

    San Antonio, Texas, 78215

  • Clinical Trials of Texas Inc.

    San Antonio, Texas, 78229

  • Diabetes and Glandular Disease Clinic, P.A.

    San Antonio, Texas, 78229

  • Endeavor Clinical Trials, LLC

    San Antonio, Texas, 78229

  • Pinnacle Clinical Research

    San Antonio, Texas, 78240

  • Covenant Metabolic Specialists, LLC

    Sarasota, Florida, 34240

  • Headlands Research Sarasota

    Sarasota, Florida, 34243

  • Sherman Clinical Research

    Sherman, Texas, 75092

  • Louisiana Research Center LLC

    Shreveport, Louisiana, 71105

  • Digestive Research Alliance of Michiana

    South Bend, Indiana, 46635

  • FC Research LLC

    South Dartmouth, Massachusetts, 02747

  • GI Alliance Arizona Digestive Health-Sun City

    Sun City, Arizona, 85351

  • Kansas Medical Clinic, PA

    Topeka, Kansas, 66606

  • IVGI

    Ventura, California, 93003

  • Impact Research Institute

    Waco, Texas, 76710

  • Care Access Research

    Warwick, Rhode Island, 02886

  • Digestive Health Research of North Texas

    Wichita Falls, Texas, 76301

  • Trial Management Associates, LLC

    Wilmington, North Carolina, 28403

  • Conquest Research

    Winter Park, Florida, 32789

  • Care Access

    Yonkers, New York, 10701

Other trials in United States

Poland7 sites

  • Centrum Medyczne Pratia

    Katowice, 40-081

  • Krakowskie Centrum Medyczne sp z o.o.

    Krakow, 31-501

  • Hepatology Outpatient Clinic

    Śląskie, 41-400

  • ID Clinic Arkadiusz Pisula

    Śląskie, 41-400

  • Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728

  • Centrum Medyczne K2J2

    Wołomin, 05-200

  • FutureMeds

    Wroclaw, 50-088

Other trials in Poland

Canada6 sites

  • University of Calgary Liver Unit

    Calgary, Alberta, T2N 4Z6

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • Office of Dr. Gauthier

    North Bay, Ontario, P1B 2H3

  • Toronto Liver Centre

    Toronto, Ontario, M6H 3M1

  • Office of Dr. Gauthier

    Toronto, Ontario, M6H-3M1

  • GI Research Institute

    Vancouver, British Columbia, V6Z 2K5

Other trials in Canada

Puerto Rico1 site

  • FDI Clinical Research

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: 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)

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.

Read the detailed description

The indication nonalcoholic steatohepatitis [NASH]) is now referred to as metabolic dysfunction-associated steatohepatitis (MASH) and is characterized by hepatocyte necrosis, chronic inflammation, and resultant fibrosis formation.

Being tested
TVB-2640, Placebo
Keywords
NASH, Nonalcoholic Steatohepatitis, Fatty Liver Disease, Biopsy Confirmed, FASN, Fatty Liver, Liver Disease, Digestive System Diseases, MASH, Metabolic dysfunction-associated steatohepatitis
Medical subject headings
Non-alcoholic Fatty Liver Disease, Fatty Liver, Liver Diseases, Digestive System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TVB-2640Drug

    Oral dose, tablet

  • PlaceboOther

    Oral dose, tablet

Study groups in NCT04906421
Study groupRoleWhat they receive
TVB-2640 50 mgExperimentalSubjects will receive TVB-2640 PO QD for 52 weeks, with the first dose administered on Day 1.
Receives: Drug: TVB-2640
PlaceboPlacebo comparatorSubjects will receive matching placebo PO QD for 52 weeks, with the first dose administered on Day 1.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 52 Weeks

  2. 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).

    Measured: 52 Weeks

Secondary outcomes (4)

  1. Proportion of Subjects Experiencing Fibrosis Improvement of ≥1 Stage by NASH CRN Score Without Worsening of Steatohepatitis

    Proportion of subjects experiencing fibrosis improvement of ≥1 stage by NASH CRN score Without worsening of steatohepatitis (defined as no increase in NAS for ballooning, inflammation, or steatosis) at 52 weeks.

    Measured: 52 Weeks

  2. Proportion of Subjects Experiencing Resolution of Steatohepatitis and no Worsening of Liver Fibrosis (by NASH CRN Fibrosis Score)

    Resolution of steatohepatitis is defined as absence of fatty liver disease or isolated or simple steatosis without steatohepatitis and a NAS of 0 or 1 for inflammation, 0 for ballooning, and any value for steatosis.

    Measured: 52 Weeks

  3. 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

    No increase in NAS for ballooning, inflammation or steatosis.

    Measured: 52 Weeks

  4. Proportion of MRI-PDFF ≥30% Responders.

    MRI PDFF ≥30% responder is defined as a subject with ≥8% liver fat content at Baseline who achieves a relative reduction from Baseline in MRI-PDFF ≥30%.

    Measured: 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2021
  2. Study start12 Aug 2021
  3. Primary completion2 Oct 2023
  4. Study completion2 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects with liver fibrosis stage F2-F3, will be enrolled and randomized in a 2:1 ratio to receive TVB-2640, or placebo PO QD
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04906421
Sponsor's protocol ID
SB2640-CLIN-007
Status last verified
Apr 2025
First submitted
20 May 2021
Last updated
9 May 2025
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39396529

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TVB-2640 in people with Metabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver Disease, run by Sagimet Biosciences Inc. at 117 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States, Poland, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) Without Worsening of Fibrosis (by NASH Clinical Research Network [CRN] Fibrosis Score). (time frame: 52 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04906421, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.

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