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A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis | Clinical Trials | Clareo Health

WITHDRAWNPHASE3

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

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)

NCT06594523•Sagimet Biosciences Inc.

View on ClinicalTrials.gov

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.

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).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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/m\^2 for Asian patients and ≥25 kg/m\^2 for patients of other races.
•4. Presence of metabolic risk factor(s), as follows:
•1. T2DM.
•OR
•2. 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.
+19 more criteria

Exclusion Criteria

•1. Previous intake of an approved MASH medication.
•2. Exclusionary laboratory values:
•1. ALT and/or AST \>5 × ULN.
•2. ALP ≥2 × ULN.
•3. Total serum bilirubin concentration \>1.3 mg/dL.
•4. Serum albumin concentration \<3.5 g/dL.
•5. INR \>1.3 except for patients receiving anticoagulant treatment.
•6. Platelet count \<140,000/μL.
•7. Fasting TG level ≥500 mg/dL.
•8. eGFR \<45 mL/min/1.73 m\^2.
+23 more criteria

Key Dates

Start Date

March 1, 2025

Primary Completion Date

December 1, 2030

Completion Date

December 1, 2030

Last Updated

May 15, 2025

Conditions

MASHNASHMetabolic Dysfunction-associated SteatohepatitisNoncirrhotic Metabolic Dysfunction-associated SteatohepatitisNonalcoholic SteatohepatitisNonalcoholic Fatty Liver

Interventions

Denifanstat

DRUG

Placebo

DRUG

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Metabolic Dysfunction Associated Steatohepatitis (MASH)Liver Fibrosis

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RECRUITINGPHASE3

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

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NASH With FibrosisMASH With Fibrosis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Study of the Link Between MASH ( Metabolic Dysfunction-Associated Steatohepatitis) and MAMs (Mitochondria-Associated Membranes ) Alteration in Patients Undergoing Bariatric Surgery - MAMBA

Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients

Evaluation of Non-Invasive Tests for Metabolic Liver Disease

Vonafexor in Patients With Impaired Renal Function and Suspected MASH (Metabolic Dysfunction-associated Steatohepatitis)