MASLDPhase 3FASCINITNCT06692283
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASH
A Phase 3 study testing denifanstat in people with MASLD and MASH, run by Sagimet Biosciences Inc..
Trial summary
A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of denifanstat 50 mg compared to placebo in patients with metabolic dysfunction-associated steatotic liver disease (MALSD)/metabolic dysfunction-associated steatohepatitis (MASH) after 52 weeks of treatment. 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 Jun 2027
- 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
- 1. Willing and able to participate in the study and provide written informed consent.
- 2. Adults between 18 and 75 years of age.
- 3. Body mass index (BMI) ≥23 kg/m2 for Asian patients and ≥25 kg/m2 for patients of other races.
- 4. Presence of metabolic risk factor(s), as follows:
- T2DM
- OR
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- At least 2 out of 4 of the following:
- BMI ≥30 kg/m2,
- 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.
- 5. For patients with T2DM:
- HbA1c ≤9.5%
- If treatment naive: patients must have been diagnosed for at least 12 weeks prior to screening
- 6. Suspected or confirmed diagnosis of MASH or MASLD or non-invasively diagnosed MASH or MASLD
- 7. Stable ALT and AST levels
Who cannot join
- 1. Previous intake of an approved MASH medication
- 2. 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.
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- International normalized ratio (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 m2.
- 3. History of excessive alcohol intake for a period of more than 3 consecutive months within 1 year prior to screening.
- 4. Presence of cirrhosis on liver histology and/or cross-sectional imaging evidence consistent with cirrhosis and/or portal hypertension.
- 5. Current or historical clinically evident hepatic decompensation.
- 6. Evidence of another form of active liver disease.
- 7. Positive serologic evidence of current infectious liver disease.
- 8. MELD score ≥12.
- 9. Planned or history of liver transplantation.
- 10. Prior or planned bariatric surgery.
- 11. 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).
- 12. Any of the following conditions or procedures within 6 months prior to the baseline visit (V1):
- Myocardial infarction
- Cardiac revascularization surgery
- Unstable angina
- Transient ischemic attack, stroke, or cerebrovascular disease
- 13. Unstable or undiagnosed arrhythmias.
- 14. Uncontrolled high BP.
- 15. Malignancy with a complete remission date within 5 years prior to the baseline visit (V1).
- 16. Any current or history of hepatocellular carcinoma.
- 17. Diabetes other than T2DM
- 18. Uncontrolled hypothyroidism.
- 19. Any other known serious disease or other disease which in the Investigator's opinion would exclude the patient from participating in the study.
- 20. Use of a nonpermitted concomitant medication within 30 days or 5 half-lives prior to 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 Metabolic Dysfunction-Associated Steatotic Liver Disease (MALSD)/Metabolic Dysfunction-Associated Steatohepatitis (MASH)
A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of denifanstat 50 mg compared to placebo in patients with metabolic dysfunction-associated steatotic liver disease (MALSD)/metabolic dysfunction-associated steatohepatitis (MASH) after 52 weeks of treatment.
Read the detailed description
Up to 2000 patients will be randomized to receive either denifanstat 50 mg or placebo.
- Conditions
- MASLD, MASH, NASH, Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis, Nonalcoholic Steatohepatitis
- Being tested
- denifanstat, Placebo
- Keywords
- fatty liver, steatohepatitis, steatotic liver
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, 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 group | Role | What they receive |
|---|---|---|
| Denifanstat 50 mg | Experimental | Denifanstat tablet, orally, once daily Receives: Drug: denifanstat |
| Placebo | Placebo comparator | Placebo tablet, orally, once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Outcome Measure: TEAEs
Incidence of treatment-emergent adverse events (TEAEs) in patients with MASLD/MASH treated with denifanstat 50 mg compared to placebo after 52 weeks of treatment.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study startMar 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sagimet Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692283
- Sponsor's protocol ID
- SB2640-CLIN-011
- Acronym
- FASCINIT
- 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
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Denifanstat in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MALSD)/Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- ClinicalTrials.gov ID
- NCT06692283
- Acronym / sponsor ID
- FASCINIT / SB2640-CLIN-011
- Conditions
- MASLD, MASH, NASH, Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis, Nonalcoholic Steatohepatitis
- Keywords
- fatty liver, steatohepatitis, steatotic liver
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sagimet Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of denifanstat 50 mg compared to placebo in patients with metabolic dysfunction-associated steatotic liver disease (MALSD)/metabolic dysfunction-associated steatohepatitis (MASH) after 52 weeks of treatment.
Detailed description
Up to 2000 patients will be randomized to receive either denifanstat 50 mg or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denifanstat 50 mg | Experimental | Drug: denifanstatDenifanstat tablet, orally, once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet, orally, once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 1. Willing and able to participate in the study and provide written informed consent.
- 2. Adults between 18 and 75 years of age.
- 3. Body mass index (BMI) ≥23 kg/m2 for Asian patients and ≥25 kg/m2 for patients of other races.
- T2DM
- OR
Key exclusion criteria (32 listed)
- 1. Previous intake of an approved MASH medication
- ALT and/or AST >5 × ULN.
- ALP ≥2 × ULN.
- Total serum bilirubin concentration >1.3 mg/dL.
- Serum albumin concentration <3.5 g/dL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| denifanstatAlso: TVB-2640Tablet | Drug | Denifanstat 50 mg |
| PlaceboMatching tablet | Drug | Placebo |
Primary outcome
Primary Safety Outcome Measure: TEAEs
Time frame: 52 weeks
Incidence of treatment-emergent adverse events (TEAEs) in patients with MASLD/MASH treated with denifanstat 50 mg compared to placebo after 52 weeks of treatment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing denifanstat in people with MASLD and MASH, 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 16 inclusion and 32 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?
Primary Safety Outcome Measure: TEAEs (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.