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)

Sagimet Biosciences Inc.0 sites2,000 target enrollmentMarch 2025

Interventionsdenifanstat Placebo

Overview

Phase: Phase 3
Intervention: denifanstat
Conditions: Not specified
Sponsor: Sagimet Biosciences Inc.
Enrollment: 2000
Primary Endpoint: Primary Safety Outcome Measure: TEAEs
Status: Withdrawn
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Detailed Description

Up to 2000 patients will be randomized to receive either denifanstat 50 mg or placebo.

Registry

clinicaltrials.gov

Start Date

March 2025

End Date

June 2027

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sagimet Biosciences Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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:
•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:

Exclusion Criteria

•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.
•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 m

Arms & Interventions

Denifanstat 50 mg

Denifanstat tablet, orally, once daily

Intervention: denifanstat

Placebo

Placebo tablet, orally, once daily

Intervention: Placebo

Outcomes

Primary Outcomes

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.