A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASH

NCT06692283 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: SB2640-CLIN-011
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

MASLD; MASH; NASH; Metabolic Dysfunction-Associated Steatotic Liver Disease; Metabolic Dysfunction-Associated Steatohepatitis; Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver

Keywords

fatty liver; steatohepatitis; steatotic liver

Outcome Measures

Primary Outcomes (1)

• 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.

  52 weeks

Study Arms (2)

Denifanstat 50 mg

EXPERIMENTAL

Denifanstat tablet, orally, once daily

Drug: denifanstat

Placebo

PLACEBO COMPARATOR

Placebo tablet, orally, once daily

Drug: Placebo

Interventions

denifanstat DRUG

Tablet

Also known as: TVB-2640

Denifanstat 50 mg

Placebo DRUG

Matching tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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/m2 for Asian patients and ≥25 kg/m2 for patients of other races.
• \. Presence of metabolic risk factor(s), as follows:
• T2DM
• 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.
• \. For patients with T2DM:
• HbA1c ≤9.5%
• If treatment naive: patients must have been diagnosed for at least 12 weeks prior to screening
• \. Suspected or confirmed diagnosis of MASH or MASLD or non-invasively diagnosed MASH or MASLD
• \. Stable ALT and AST levels

You may not qualify if:

• \. 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.
• 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.
• \. 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 and/or cross-sectional imaging evidence consistent with cirrhosis and/or portal hypertension.
• \. 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.

Sponsors & Collaborators

• Sagimet Biosciences Inc.: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Interventions

TVB-2640

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: November 18, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share