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MASHPhase 3FASCINATE-3NCT06594523

A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis

A Phase 3 study testing Denifanstat in people with MASH and NASH, run by Sagimet Biosciences Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

A randomized, double-blind, placebo-controlled Phase 3 study to determine if denifanstat 50 mg or 25 mg is effective, as compared to placebo, in resolving MASH without the worsening of fibrosis and/or in fibrosis regression without the worsening of steatohepatitis. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Denifanstat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Mar 2025to Dec 2030
Phase
Phase 3
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to participate in the study and provide written informed consent.
  • Adults between 18 and 75 years of age.
  • Body mass index (BMI) ≥23 kg/m^2 for Asian patients and ≥25 kg/m^2 for patients of other races.
  • Presence of metabolic risk factor(s), as follows:
  • T2DM.
  • OR
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  • 2 out of 4 of the following:
  • BMI ≥30 kg/m^2.
  • Hypertension, or on active antihypertensive treatment.
  • Elevated fasting serum TGs or on active treatment for hypertriglyceridemia.
  • Reduced fasting serum HDL-c or on active treatment for dyslipidemia.
  • For patients with T2DM:
  • HbA1c ≤9.5%.
  • Metformin, insulin, dipeptidyl peptidase-4 inhibitors (DPP4-Is), sodium-glucose transport protein-2 inhibitors (SGLT2-Is), and alpha-glucosidase inhibitors (α-GIs): stable dose for at least 12 weeks prior to qualifying liver biopsy and screening.
  • Sulfonylureas (SUs) and glinides: stable dose with no history of relevant hypoglycemia for at least 12 weeks prior to qualifying liver biopsy and screening.
  • GLP-1 RA: stable dose for at least 18 weeks prior to start of screening.
  • Noncirrhotic, biopsy-proven MASH with:
  • A fibrosis stage of F2 or F3.
  • NAS ≥4 with at least a score of 1 in each of the following NAS components:
  • Steatosis (scored 0 to 3).
  • Hepatocyte ballooning (scored 0 to 2).
  • Lobular inflammation (scored 0 to 3).
  • A qualifying historical liver biopsy within 6 months before the screening visit. Historical biopsy results will be confirmed by central reading.
  • If there is no available historical liver biopsy within this time period, a liver biopsy must be performed during the screening period. Patients should be deemed likely to have MASH F2/F3 fibrosis prior to proceeding to a liver biopsy, as indicated by the following:
  • FibroScan.
  • Liver stiffness measurement (LSM) ≥8.5 kPa.
  • Controlled attenuation parameter (CAP) ≥280 dB/m.
  • Aspartate aminotransferase (AST) >20 U/L.
  • Stable ALT and AST levels.

Who cannot join

  • Previous intake of an approved MASH medication.
  • Exclusionary laboratory values:
  • ALT and/or AST >5 × ULN.
  • ALP ≥2 × ULN.
  • Total serum bilirubin concentration >1.3 mg/dL.
  • Serum albumin concentration <3.5 g/dL.
Show all 33Show fewer
  • INR >1.3 except for patients receiving anticoagulant treatment.
  • Platelet count <140,000/μL.
  • Fasting TG level ≥500 mg/dL.
  • eGFR <45 mL/min/1.73 m^2.
  • History of excessive alcohol intake for a period of more than 3 consecutive months within 1 year prior to screening.
  • Presence of cirrhosis on liver histology according to the assessment of the central reader.
  • Current or historical clinically evident hepatic decompensation.
  • Evidence of another form of active liver disease.
  • Positive serologic evidence of current infectious liver disease.
  • MELD score ≥12.
  • Planned or history of liver transplantation.
  • Prior or planned bariatric surgery.
  • Gain or loss of >5% of body weight in the 3 months or >10% of body weight in the 6 months prior to screening, qualifying liver biopsy, and the baseline visit (V1).
  • Any of the following within 6 months prior to the baseline visit (V1):
  • Myocardial infarction.
  • CABG/PTCA.
  • Unstable angina.
  • Transient ischemic attack, stroke, or cerebrovascular disease.
  • Unstable or undiagnosed arrhythmias.
  • Uncontrolled high BP.
  • Malignancy with a complete remission date within 5 years prior to the baseline visit (V1).
  • Any current or history of hepatocellular carcinoma.
  • Diabetes other than T2DM.
  • Uncontrolled hypothyroidism.
  • Any other known serious disease or other disease which in the Investigator's opinion would exclude the patient from participating in the study.
  • Previous intake of an approved MASH medication, unless there is at least a 6-month wash-out period between the last date of intake of the approved MASH medication and date of screening.
  • Use of a nonpermitted concomitant medication within 30 days or 5 half-lives prior to the qualifying liver biopsy and screening.

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Denifanstat in Patients With Noncirrhotic Metabolic Dysfunction-associated Steatohepatitis (MASH) and F2/F3 Fibrosis (FASCINATE-3)

A randomized, double-blind, placebo-controlled Phase 3 study to determine if denifanstat 50 mg or 25 mg is effective, as compared to placebo, in resolving MASH without the worsening of fibrosis and/or in fibrosis regression without the worsening of steatohepatitis.

Read the detailed description

Approximately 1260 patients (including at least 60% of F3 patients) will be enrolled to receive either denifanstat 50 mg (580 patients), placebo (580 patients), or denifanstat 25 mg (100 patients).

Being tested
Denifanstat, Placebo
Keywords
fibrosis, fatty liver, steatohepatitis
Medical subject headings
Non-alcoholic Fatty Liver Disease, Fibrosis, Fatty Liver

What participants receive

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

  • DenifanstatDrug

    Also called TVB-2640

    Tablet

  • PlaceboDrug

    Matching Tablet

Study groups in NCT06594523
Study groupRoleWhat they receive
Denifanstat 50 mgExperimentalDenifanstat tablet, orally, once daily
Receives: Drug: Denifanstat
Denifanstat 25 mgExperimentalDenifanstat tablet, orally, once daily
Receives: Drug: Denifanstat
PlaceboPlacebo comparatorPlacebo tablet, orally, once daily
Receives: Drug: Placebo

What is being measured

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

  1. Dual Primary Efficacy Endpoint 1: Interim Analysis: MASH Resolution (denifanstat 50 mg compared to placebo)

    Proportion of patients who achieve MASH resolution (defined as NAS* of 0 for ballooning, and 0 or 1 for inflammation) without worsening of fibrosis stage at Week 52.

    *NAS: nonalcoholic fatty liver disease activity score

    Measured: 52 weeks

  2. Dual Primary Efficacy Endpoint 2: Interim Analysis: Improvement in Fibrosis (denifanstat 50 mg compared to placebo)

    Proportion of patients who achieve at least a 1-point improvement in fibrosis stage and without worsening of steatohepatitis (defined as no increase in NAS* for ballooning, inflammation, or steatosis) at Week 52.

    Measured: 52 weeks

  3. Primary Endpoint: End of Study Analysis: Liver-related Composite Clinical Outcome (denifanstat 50 mg compared to placebo)

    Time to first occurrence of any event from the following composite clinical outcome: death from any cause; histopathologic progression to cirrhosis; liver transplant; Model for End-Stage Liver Disease (MELD) score ≥15; Liver decompensation event defined by: Ascites requiring chronic diuretic treatment, Hepatic encephalopathy grade 2 or above requiring at least a 24-hour hospitalization, Variceal hemorrhage requiring hospitalization and transfusion of blood.

    Measured: 234 weeks

Timeline

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

  1. First posted19 Sep 2024
  2. Study startMar 2025 (estimated)
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Why it stopped: Business decision

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06594523
Sponsor's protocol ID
SB2640-CLIN-010
Acronym
FASCINATE-3
Status last verified
May 2025
First submitted
10 Sep 2024
Last updated
15 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dembitz V, James SC, Gallipoli P. Targeting lipid metabolism in acute myeloid leukemia: biological insights and therapeutic opportunities. Leukemia. 2025 Aug;39(8):1814-1823. doi: 10.1038/s41375-025-02645-z. Epub 2025 May 22.

    PubMed 40404984

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Denifanstat in people with MASH and NASH, run by Sagimet Biosciences Inc..

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 29 inclusion and 33 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: withdrawn, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Dual Primary Efficacy Endpoint 1: Interim Analysis: MASH Resolution (denifanstat 50 mg compared to placebo) (time frame: 52 weeks). The study lists 3 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 NCT06594523, 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 15 May 2025.

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